TRISODIUM CITRATE DIHYDRATE
UNII B22547B95K

Substance Identification & Data

This profile provides standardized clinical and technical data for Trisodium Citrate Dihydrate, uniquely identified by the FDA Unique Ingredient Identifier (UNII) B22547B95K.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 6132-04-3 and the RxNorm Concept ID (RxCUI) 221163. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.

FDA UNII Code
B22547B95K
CAS Registry Number
6132-04-3
RxNorm Concept ID
221163

Detailed Substance Profile

Preferred Name
TRISODIUM CITRATE DIHYDRATE
Official standardized name for this substance within the FDA UNII nomenclature system.
Molecular Formula
B22547B95K
The specific atomic composition represented as a molecular structure string.
InChIKey
C6H5O7.3Na.2H2O
International Chemical Identifier digital signature for unique molecular identification.
SMILES String
NLJMYIDDQXHKNR-UHFFFAOYSA-K
Line notation for describing the chemical structure and connectivity of atoms.
NCI Thesaurus
C66642
National Cancer Institute reference terminology for clinical and research data.
PubChem CID
71474
Unique identification number in the NCBI database of chemical substances.
Substance Type
chemical
ISO 11238 classification category (e.g., Chemical, Polymer, Protein).
Ingredient Role
[Na+].[O-]C(CC(CC([O-])=O)(O)C(=O)[O-])=O.O.[Na+].[Na+].O

Synonyms and Nomenclature

This section provides a complete list of nomenclature and identifier mappings for Trisodium Citrate Dihydrate. Identifiers are organized into official regulatory terms, commercial trade names, and technical systematic synonyms used to ensure accurate identification across clinical pharmaceutical databases, regulatory filings, and electronic health records.

Common Names & Synonyms

1,2,3-PROPANETRICARBOXYLIC ACID, 2-HYDROXY-, TRISODIUM SALT, DIHYDRATE
CITRIC ACID, TRISODIUM SALT, DIHYDRATE
NATRII CITRAS, DEHYDRATE [WHO-IP LATIN]
SODIUM CITRATE [EP MONOGRAPH]
SODIUM CITRATE [FHFI]
SODIUM CITRATE DIHYDRATE [EP monograph]
SODIUM CITRATE DIHYDRATE [MI]
SODIUM CITRATE DIHYDRATE [VANDF]
SODIUM CITRATE DIHYDRATE [WHO-DD]
SODIUM CITRATE HYDRATE [JAN]
SODIUM CITRATE HYDROUS
SODIUM CITRATE HYDROUS [II]
SODIUM CITRATE, DIHYDRATE [WHO-IP]
TRISODIUM CITRATE DIHYDRATE [II]
TRISODIUM CITRATE DIHYDRATE [USP MONOGRAPH]

Systematic Nomenclature

SODIUM CITRATE DIHYDRATE
SODIUM CITRATE HYDRATE
SODIUM CITRATE, DIHYDRATE
TRISODIUM CITRATE DIHYDRATE

Technical Codes

FEMA NO. 3026
N-1560

NDC Products Containing TRISODIUM CITRATE DIHYDRATE

This unique ingredient identifier is listed as an ingredient or substance in the following products in the NDC directory:

Manufacturer Quick Index

Note: Due to the high number of listings (500), only Active Listings are currently displayed. Display is limited to the first 200 products.
→ AbbVie Inc. 1
→ Actavis Pharma, Inc. 5
→ Alcon Laboratories, Inc. 2
→ Allergan, Inc. 8
→ Amphastar Pharmaceuticals, Inc. 2
→ Baxter Healthcare Corporation 15
→ Crown Laboratories, Inc. 1
→ E.R. Squibb & Sons, L.L.C. 3
→ Eli Lilly and Company 13
→ Genentech, Inc. 1
→ GlaxoSmithKline LLC 1
→ Haleon US Holdings LLC 1
→ Henry Schein, Inc. 6
→ Hikma Pharmaceuticals USA Inc. 12
→ Hospira, Inc. 14
→ Lannett Company, Inc. 1
→ Merck Sharp & Dohme LLC 14
→ Mylan Pharmaceuticals Inc. 5
→ PAI Holdings, LLC dba PAI Pharma 9
→ PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma 2
→ Padagis US LLC 1
→ Pfizer Laboratories Div Pfizer Inc 2
→ Roerig 2
→ Sandoz Inc 13
→ SpecGx LLC 2
→ Teva Pharmaceuticals USA, Inc. 13
→ WALGREENS CO. 5
→ Walgreen Company 17
→ Walgreens 21
→ West-Ward Pharmaceuticals Corp 2
→ Xttrium Laboratories, Inc 2
→ Xttrium Laboratories, Inc. 2
→ sanofi-aventis U.S. LLC 2

AbbVie Inc.

NDC Product
Human Prescription Drug

Vuity
NDC 0074-7098

Generic Name
Pilocarpine Hydrochloride
Dosage Form
Solution/ Drops
Route
Ophthalmic
Marketing
NDA
Active Listing

Actavis Pharma, Inc.

NDC Product
Human Prescription Drug

Buprenorphine
NDC 0228-3153

Generic Name
Buprenorphine
Dosage Form
Tablet
Route
Sublingual
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Buprenorphine And Naloxone
NDC 0228-3154

Generic Name
Buprenorphine And Naloxone
Dosage Form
Tablet
Route
Sublingual
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Buprenorphine And Naloxone
NDC 0228-3155

Generic Name
Buprenorphine And Naloxone
Dosage Form
Tablet
Route
Sublingual
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Buprenorphine
NDC 0228-3156

Generic Name
Buprenorphine
Dosage Form
Tablet
Route
Sublingual
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Levetiracetam
NDC 0472-0235

Generic Name
Levetiracetam
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Alcon Laboratories, Inc.

NDC Product
Human Prescription Drug

Miostat
NDC 0065-0023

Generic Name
Carbachol
Dosage Form
Solution
Route
Ophthalmic
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Inveltys
NDC 0065-9307

Generic Name
Loteprednol Etabonate
Dosage Form
Suspension
Route
Ophthalmic
Marketing
NDA
Active Listing

Allergan, Inc.

NDC Product
Human Otc Drug

Refresh Tears Pf
NDC 0023-3110

Generic Name
Carboxymethylcellulose Sodium, Glycerin
Dosage Form
Solution/ Drops
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Refresh Optive
NDC 0023-3240

Generic Name
Carboxymethylcellulose Sodium And Glycerin
Dosage Form
Solution/ Drops
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Refresh Optive
NDC 0023-3416

Generic Name
Carboxymethylcellulose Sodium, Glycerin
Dosage Form
Solution/ Drops
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Prescription Drug

Acuvail
NDC 0023-3507

Generic Name
Ketorolac Tromethamine
Dosage Form
Solution/ Drops
Route
Ophthalmic
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Refresh Relieva Pf Xtra
NDC 0023-3782

Generic Name
Carboxymethylcellulose Sodium And Glycerin
Dosage Form
Solution/ Drops
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Refresh Optive Drops
NDC 0023-5459

Generic Name
Carboxymethylcellulose Sodium And Glycerin
Dosage Form
Solution/ Drops
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Refresh Relieva
NDC 0023-6630

Generic Name
Carboxymethylcellulose Sodium, Glycerin
Dosage Form
Solution/ Drops
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Refresh Relieva Preservative Free
NDC 0023-6634

Generic Name
Carboxymethylcellulose Sodium And Glycerin
Dosage Form
Solution/ Drops
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing

Amphastar Pharmaceuticals, Inc.

NDC Product
Human Prescription Drug

Isoproterenol Hydrochloride
NDC 0548-9501

Generic Name
Isoproterenol Hydrochloride
Dosage Form
Injection, Solution
Route
Intracardiac; Intramuscular; Intravenous; Subcutaneous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Isoproterenol Hydrochloride
NDC 0548-9502

Generic Name
Isoproterenol Hydrochloride
Dosage Form
Injection, Solution
Route
Intracardiac; Intramuscular; Intravenous; Subcutaneous
Marketing
ANDA
Active Listing

Baxter Healthcare Corporation

NDC Product
Human Prescription Drug

Oxacillin
NDC 0338-1015

Generic Name
Oxacillin
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Nafcillin
NDC 0338-1019

Generic Name
Nafcillin
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Penicillin G Potassium
NDC 0338-1021

Generic Name
Penicillin G
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Penicillin G Potassium
NDC 0338-1023

Generic Name
Penicillin G
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Penicillin G Potassium
NDC 0338-1025

Generic Name
Penicillin G
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Plasma Derivative

Tisseel Fibrin Sealant
NDC 0338-4210

Generic Name
Fibrinogen Human, Human Thrombin
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Plasma Derivative

Tisseel Fibrin Sealant
NDC 0338-4211

Generic Name
Fibrinogen Human, Human Thrombin
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Plasma Derivative

Tisseel Fibrin Sealant
NDC 0338-4212

Generic Name
Fibrinogen Human, Human Thrombin
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Plasma Derivative

Tisseel Fibrin Sealant
NDC 0338-4301

Generic Name
Fibrinogen Human, Human Thrombin
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Plasma Derivative

Tisseel Fibrin Sealant
NDC 0338-4302

Generic Name
Fibrinogen Human, Human Thrombin
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Plasma Derivative

Tisseel Fibrin Sealant
NDC 0338-4303

Generic Name
Fibrinogen Human, Human Thrombin
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Micafungin In Sodium Chloride
NDC 0338-9051

Generic Name
Micafungin In Sodium Chloride
Dosage Form
Injection
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Micafungin In Sodium Chloride
NDC 0338-9053

Generic Name
Micafungin In Sodium Chloride
Dosage Form
Injection
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Micafungin In Sodium Chloride
NDC 0338-9055

Generic Name
Micafungin In Sodium Chloride
Dosage Form
Injection
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Anticoagulant Sodium Citrate
NDC 0338-9669

Generic Name
Trisodium Citrate Dihydrate
Dosage Form
Solution
Route
Extracorporeal
Marketing
NDA
Active Listing

Crown Laboratories, Inc.

NDC Product
Human Otc Drug

Panoxyl Clarifying Exfoliant
NDC 0316-0296

Generic Name
Salicylic Acid
Dosage Form
Liquid
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

E.R. Squibb & Sons, L.L.C.

NDC Product
Human Prescription Drug

Opdivo
NDC 0003-3734

Generic Name
Nivolumab
Dosage Form
Injection
Route
Intravenous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Opdivo
NDC 0003-3772

Generic Name
Nivolumab
Dosage Form
Injection
Route
Intravenous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Opdivo
NDC 0003-3774

Generic Name
Nivolumab
Dosage Form
Injection
Route
Intravenous
Marketing
BLA
Active Listing

Eli Lilly and Company

NDC Product
Human Prescription Drug

Trulicity
NDC 0002-1433

Generic Name
Dulaglutide
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Trulicity
NDC 0002-1434

Generic Name
Dulaglutide
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Taltz
NDC 0002-1445

Generic Name
Ixekizumab
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Trulicity
NDC 0002-2236

Generic Name
Dulaglutide
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Trulicity
NDC 0002-3182

Generic Name
Dulaglutide
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Omvoh
NDC 0002-7575

Generic Name
Mirikizumab-mrkz
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Taltz
NDC 0002-7724

Generic Name
Ixekizumab
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Lyumjev
NDC 0002-7726

Generic Name
Insulin Lispro-aabc
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Lyumjev
NDC 0002-7728

Generic Name
Insulin Lispro-aabc
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Omvoh
NDC 0002-8011

Generic Name
Mirikizumab-mrkz
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Lyumjev Kwikpen
NDC 0002-8207

Generic Name
Insulin Lispro-aabc
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Lyumjev Kwikpen
NDC 0002-8228

Generic Name
Insulin Lispro-aabc
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Lyumjev Junior Kwikpen
NDC 0002-8351

Generic Name
Insulin Lispro-aabc
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing

Genentech, Inc.

NDC Product
Human Prescription Drug

Cellcept
NDC 0004-0261

Generic Name
Mycophenolate Mofetil
Dosage Form
Powder, For Suspension
Route
Oral
Marketing
NDA
Active Listing

GlaxoSmithKline LLC

NDC Product
Human Prescription Drug

Jemperli
NDC 0173-0898

Generic Name
Dostarlimab
Dosage Form
Injection
Route
Intravenous
Marketing
BLA
Active Listing

Haleon US Holdings LLC

NDC Product
Human Otc Drug

Abreva Rapid Pain Relief
NDC 0135-0400

Generic Name
Glycerin, Lidocaine
Dosage Form
Gel
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Henry Schein, Inc.

NDC Product
Human Prescription Drug

Nalbuphine Hydrochloride
NDC 0404-9766

Generic Name
Nalbuphine Hydrochloride
Dosage Form
Injection
Route
Intramuscular; Intravenous; Subcutaneous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Nalbuphine Hydrochloride
NDC 0404-9767

Generic Name
Nalbuphine Hydrochloride
Dosage Form
Injection
Route
Intramuscular; Intravenous; Subconjunctival
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Ondansetron
NDC 0404-9930

Generic Name
Ondansetron
Dosage Form
Injection
Route
Intramuscular; Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Phenylephrine Hydrochloride
NDC 0404-9931

Generic Name
Phenylephrine Hydrochloride
Dosage Form
Injection
Route
Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Dopamine Hydrochloride
NDC 0404-9981

Generic Name
Dopamine Hydrochloride
Dosage Form
Injection, Solution, Concentrate
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Dopamine Hydrochloride
NDC 0404-9982

Generic Name
Dopamine Hydrochloride
Dosage Form
Injection, Solution, Concentrate
Route
Intravenous
Marketing
NDA
Active Listing

Hikma Pharmaceuticals USA Inc.

NDC Product
Human Prescription Drug

Posaconazole
NDC 0054-0449

Generic Name
Posaconazole
Dosage Form
Suspension
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Amoxicillin
NDC 0143-9886

Generic Name
Amoxicillin
Dosage Form
Powder, For Suspension
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Amoxicillin
NDC 0143-9887

Generic Name
Amoxicillin
Dosage Form
Powder, For Suspension
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Amoxicillin
NDC 0143-9888

Generic Name
Amoxicillin
Dosage Form
Powder, For Suspension
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Amoxicillin
NDC 0143-9889

Generic Name
Amoxicillin
Dosage Form
Powder, For Suspension
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Ondansetron
NDC 0641-6078

Generic Name
Ondansetron
Dosage Form
Injection
Route
Intramuscular; Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Ondansetron
NDC 0641-6079

Generic Name
Ondansetron
Dosage Form
Injection
Route
Intramuscular; Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Ondansetron
NDC 0641-6080

Generic Name
Ondansetron
Dosage Form
Injection
Route
Intramuscular; Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Phenylephrine Hydrochloride
NDC 0641-6142

Generic Name
Phenylephrine Hydrochloride
Dosage Form
Injection
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Phenylephrine Hydrochloride
NDC 0641-6229

Generic Name
Phenylephrine Hydrochloride
Dosage Form
Injection
Route
Intravenous
Marketing
NDA
Active Listing

Hospira, Inc.

NDC Product
Human Prescription Drug

Ondansetron
NDC 0409-0009

Generic Name
Ondansetron
Dosage Form
Injection, Solution
Route
Intramuscular; Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Nalbuphine Hydrochloride
NDC 0409-1463

Generic Name
Nalbuphine Hydrochloride
Dosage Form
Injection, Solution
Route
Intramuscular; Intravenous; Subcutaneous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Nalbuphine Hydrochloride
NDC 0409-1463

Generic Name
Nalbuphine Hydrochloride
Dosage Form
Injection, Solution
Route
Intramuscular; Intravenous; Subcutaneous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Nalbuphine Hydrochloride
NDC 0409-1464

Generic Name
Nalbuphine Hydrochloride
Dosage Form
Injection, Solution
Route
Intramuscular; Intravenous; Subcutaneous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Nalbuphine Hydrochloride
NDC 0409-1465

Generic Name
Nalbuphine Hydrochloride
Dosage Form
Injection, Solution
Route
Intramuscular; Intravenous; Subcutaneous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Nalbuphine Hydrochloride
NDC 0409-1467

Generic Name
Nalbuphine Hydrochloride
Dosage Form
Injection, Solution
Route
Intramuscular; Intravenous; Subcutaneous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Butorphanol Tartrate
NDC 0409-1623

Generic Name
Butorphanol Tartrate
Dosage Form
Injection, Solution
Route
Intramuscular; Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Butorphanol Tartrate
NDC 0409-1626

Generic Name
Butorphanol Tartrate
Dosage Form
Injection, Solution
Route
Intramuscular; Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Ondansetron
NDC 0409-2271

Generic Name
Ondansetron
Dosage Form
Injection, Solution
Route
Intramuscular; Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Diltiazem Hydrochloride
NDC 0409-4350

Generic Name
Diltiazem Hydrochloride
Dosage Form
Injection, Powder, Lyophilized, For Solution
Route
Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Ondansetron
NDC 0409-4755

Generic Name
Ondansetron
Dosage Form
Injection, Solution
Route
Intramuscular; Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Ondansetron
NDC 0409-4759

Generic Name
Ondansetron
Dosage Form
Injection, Solution
Route
Intramuscular; Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Dopamine Hydrochloride
NDC 0409-5820

Generic Name
Dopamine Hydrochloride
Dosage Form
Injection, Solution, Concentrate
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Dopamine Hydrochloride
NDC 0409-9104

Generic Name
Dopamine Hydrochloride
Dosage Form
Injection, Solution, Concentrate
Route
Intravenous
Marketing
NDA
Active Listing

Lannett Company, Inc.

NDC Product
Human Prescription Drug

Mycophenolate Mofetil
NDC 0527-5160

Generic Name
Mycophenolate Mofetil
Dosage Form
Powder, For Suspension
Route
Oral
Marketing
ANDA
Active Listing

Merck Sharp & Dohme LLC

NDC Product
Human Prescription Drug

Isentress
NDC 0006-0473

Generic Name
Raltegravir
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Isentress
NDC 0006-0477

Generic Name
Raltegravir
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Zinplava
NDC 0006-3025

Generic Name
Bezlotoxumab
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Isentress
NDC 0006-3080

Generic Name
Raltegravir
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Isentress
NDC 0006-3603

Generic Name
Raltegravir
Dosage Form
Granule, For Suspension
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Winrevair
NDC 0006-5087

Generic Name
Sotatercept-csrk
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Winrevair
NDC 0006-5088

Generic Name
Sotatercept-csrk
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Winrevair
NDC 0006-5090

Generic Name
Sotatercept-csrk
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Winrevair
NDC 0006-5091

Generic Name
Sotatercept-csrk
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Noxafil
NDC 0085-1328

Generic Name
Posaconazole
Dosage Form
Suspension
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Temodar
NDC 0085-1381

Generic Name
Temozolomide
Dosage Form
Injection, Powder, Lyophilized, For Solution
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Noxafil
NDC 0085-2224

Generic Name
Posaconazole
Dosage Form
Powder, For Suspension
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Noxafil
NDC 0085-4324

Generic Name
Posaconazole
Dosage Form
Tablet, Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Noxafil
NDC 0085-4331

Generic Name
Posaconazole
Dosage Form
Solution
Route
Intravenous
Marketing
NDA
Active Listing

Mylan Pharmaceuticals Inc.

NDC Product
Human Prescription Drug

Formoterol Fumarate
NDC 0378-1631

Generic Name
Formoterol Fumarate Dihydrate
Dosage Form
Solution
Route
Respiratory (inhalation)
Marketing
NDA AUTHORIZED GENERIC
Active Listing
NDC Product
Human Prescription Drug

Buprenorphine And Naloxone
NDC 0378-8765

Generic Name
Buprenorphine And Naloxone
Dosage Form
Film
Route
Buccal; Sublingual
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Buprenorphine And Naloxone
NDC 0378-8766

Generic Name
Buprenorphine And Naloxone
Dosage Form
Film
Route
Buccal; Sublingual
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Buprenorphine And Naloxone
NDC 0378-8767

Generic Name
Buprenorphine And Naloxone
Dosage Form
Film
Route
Buccal; Sublingual
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Buprenorphine And Naloxone
NDC 0378-8768

Generic Name
Buprenorphine And Naloxone
Dosage Form
Film
Route
Buccal; Sublingual
Marketing
ANDA
Active Listing

PAI Holdings, LLC dba PAI Pharma

NDC Product
Human Prescription Drug

Ondansetron
NDC 0121-0882

Generic Name
Ondansetron
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Milk Of Magnesia Concentrate
NDC 0121-0940

Generic Name
Magnesium Hydroxide
Dosage Form
Suspension
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Prescription Drug

Potassium Chloride
NDC 0121-0948

Generic Name
Potassium Chloride
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Potassium Chloride
NDC 0121-1896

Generic Name
Potassium Chloride
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Potassium Chloride
NDC 0121-2847

Generic Name
Potassium Chloride
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Potassium Chloride
NDC 0121-4948

Generic Name
Potassium Chloride
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma

NDC Product
Human Prescription Drug

Buprenorphine Hydrochloride
NDC 0121-1019

Generic Name
Buprenorphine Hydrochloride
Dosage Form
Tablet
Route
Sublingual
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Buprenorphine Hydrochloride
NDC 0121-2038

Generic Name
Buprenorphine Hydrochloride
Dosage Form
Tablet
Route
Sublingual
Marketing
ANDA
Active Listing

Padagis US LLC

NDC Product
Human Prescription Drug

Spironolactone
NDC 0574-1133

Generic Name
Spironolactone
Dosage Form
Suspension
Route
Oral
Marketing
NDA AUTHORIZED GENERIC
Active Listing

Pfizer Laboratories Div Pfizer Inc

NDC Product
Human Prescription Drug

Ngenla
NDC 0069-0505

Generic Name
Somatrogon-ghla
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Ngenla
NDC 0069-0520

Generic Name
Somatrogon-ghla
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing

Roerig

NDC Product
Human Prescription Drug

Vfend
NDC 0049-3160

Generic Name
Voriconazole
Dosage Form
Powder, For Suspension
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Diflucan
NDC 0049-3450

Generic Name
Fluconazole
Dosage Form
Powder, For Suspension
Route
Oral
Marketing
NDA
Active Listing

Sandoz Inc

NDC Product
Human Prescription Drug

Palonosetron Hydrochloride
NDC 0781-3312

Generic Name
Palonosetron Hydrochloride
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Palonosetron Hydrochloride
NDC 0781-3415

Generic Name
Palonosetron Hydrochloride
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Phenylephrine Hydrochloride
NDC 0781-3422

Generic Name
Phenylephrine Hydrochloride
Dosage Form
Injection
Route
Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Linezolid
NDC 0781-3431

Generic Name
Linezolid
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Linezolid
NDC 0781-3433

Generic Name
Linezolid
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Phenylephrine Hydrochloride
NDC 0781-3458

Generic Name
Phenylephrine Hydrochloride
Dosage Form
Injection
Route
Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Phenylephrine Hydrochloride
NDC 0781-3466

Generic Name
Phenylephrine Hydrochloride
Dosage Form
Injection
Route
Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Budesonide
NDC 0781-7515

Generic Name
Budesonide
Dosage Form
Suspension
Route
Respiratory (inhalation)
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Budesonide
NDC 0781-7516

Generic Name
Budesonide
Dosage Form
Suspension
Route
Respiratory (inhalation)
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Budesonide
NDC 0781-7517

Generic Name
Budesonide
Dosage Form
Suspension
Route
Respiratory (inhalation)
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Phenylephrine Hydrochloride
NDC 0781-9226

Generic Name
Phenylephrine Hydrochloride
Dosage Form
Injection
Route
Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Phenylephrine Hydrochloride
NDC 0781-9227

Generic Name
Phenylephrine Hydrochloride
Dosage Form
Injection
Route
Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Phenylephrine Hydrochloride
NDC 0781-9228

Generic Name
Phenylephrine Hydrochloride
Dosage Form
Injection
Route
Intravenous
Marketing
ANDA
Active Listing

SpecGx LLC

NDC Product
Human Prescription Drug

Methadose
NDC 0406-0527

Generic Name
Methadone Hydrochloride
Dosage Form
Concentrate
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Methadose Sugar-free
NDC 0406-8725

Generic Name
Methadone Hydrochloride
Dosage Form
Concentrate
Route
Oral
Marketing
NDA
Active Listing

Teva Pharmaceuticals USA, Inc.

NDC Product
Human Prescription Drug

Levalbuterol
NDC 0093-4145

Generic Name
Levalbuterol
Dosage Form
Solution
Route
Respiratory (inhalation)
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Levalbuterol
NDC 0093-4146

Generic Name
Levalbuterol
Dosage Form
Solution
Route
Respiratory (inhalation)
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Levalbuterol
NDC 0093-4148

Generic Name
Levalbuterol
Dosage Form
Solution
Route
Respiratory (inhalation)
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Erythromycin
NDC 0093-5571

Generic Name
Erythromycin
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Drug For Further Processing

NDC 0093-5571

Generic Name
Erythromycin
Dosage Form
Tablet, Film Coated
Route
N/A
Marketing
DRUG FOR FURTHER PROCESSING
Active Listing
NDC Product
Drug For Further Processing

NDC 0093-5572

Generic Name
Erythromycin
Dosage Form
Tablet, Film Coated
Route
N/A
Marketing
DRUG FOR FURTHER PROCESSING
Active Listing
NDC Product
Human Prescription Drug

Erythromycin
NDC 0093-5572

Generic Name
Erythromycin
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Arformoterol Tartrate
NDC 0093-5955

Generic Name
Arformoterol Tartrate
Dosage Form
Solution
Route
Respiratory (inhalation)
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Budesonide
NDC 0093-6815

Generic Name
Budesonide
Dosage Form
Suspension
Route
Respiratory (inhalation)
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Budesonide
NDC 0093-6815

Generic Name
Budesonide
Dosage Form
Suspension
Route
Respiratory (inhalation)
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Budesonide
NDC 0093-6816

Generic Name
Budesonide
Dosage Form
Suspension
Route
Respiratory (inhalation)
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Budesonide
NDC 0093-6816

Generic Name
Budesonide
Dosage Form
Suspension
Route
Respiratory (inhalation)
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Budesonide
NDC 0093-6817

Generic Name
Budesonide
Dosage Form
Suspension
Route
Respiratory (inhalation)
Marketing
ANDA
Active Listing

WALGREENS CO.

NDC Product
Human Otc Drug

Walgreens Nighttime Allergy Relief
NDC 0363-6251

Generic Name
Doxylamine Succinate
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Walgreenchildrens Pain Fever
NDC 0363-6950

Generic Name
Acetaminophen
Dosage Form
Suspension
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Walgreen Childrens Pain Plus Fever
NDC 0363-6958

Generic Name
Acetaminophen
Dosage Form
Suspension
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Walgreen Company

NDC Product
Human Otc Drug

Tussin Dm Max Nighttime
NDC 0363-1043

Generic Name
Dextromethorphan Hbr, Doxylamine Succinate
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Childrens Mucus Cough And Congestion Relief
NDC 0363-1056

Generic Name
Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Cold And Flu Day, Night
NDC 0363-1213

Generic Name
Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, P...
Dosage Form
Kit
Route
N/A
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Cold And Flu Daytime Nighttime Severe
NDC 0363-4278

Generic Name
Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephr...
Dosage Form
Kit
Route
N/A
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Nasal Decongestant Pe
NDC 0363-4531

Generic Name
Phenylephrine Hcl
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Sinus Pe Congestion
NDC 0363-4534

Generic Name
Diphenhydramine Hcl, Phenylephrine Hcl
Dosage Form
Kit
Route
N/A
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Severe Congestion And Cough
NDC 0363-8004

Generic Name
Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Cold, Flu And Sore Throat
NDC 0363-8005

Generic Name
Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephr...
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Childrens Allergy Relief
NDC 0363-8018

Generic Name
Diphenhydramine Hcl
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Sleep Aid
NDC 0363-8020

Generic Name
Diphenhydramine Hcl
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Dm Max
NDC 0363-8031

Generic Name
Dextromethorphan Hbr, Guaifenesin
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Cold And Flu
NDC 0363-9042

Generic Name
Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephr...
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Childrens Cold
NDC 0363-9057

Generic Name
Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Sleep Aid Plus Pain Relief
NDC 0363-9074

Generic Name
Acetaminophen, Diphenhydramine Hcl
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Cold And Flu Day
NDC 0363-9912

Generic Name
Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Cold And Flu Night
NDC 0363-9913

Generic Name
Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Walgreens

NDC Product
Human Otc Drug

Cold And Congestion Childrens Nighttime
NDC 0363-0058

Generic Name
Diphenhydramine Hci, Phenylephrine Hcl
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Wal Dryl Childrens Allergy
NDC 0363-0092

Generic Name
Diphenhydramine Hydrochloride
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Mucus Relief All In One Maximum Strength
NDC 0363-0886

Generic Name
Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephr...
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Cold And Flu Nighttime
NDC 0363-3430

Generic Name
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Suc...
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Cough Cold And Sore Throat Childrens
NDC 0363-4050

Generic Name
Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephr...
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Nighttime Cough
NDC 0363-4990

Generic Name
Dextromethorphan Hbr, Doxylamine Succinate
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Walgreens
NDC 0363-6502

Generic Name
Hemorrhoidal Cooling Gel
Dosage Form
Gel
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Mucus Relief All In One Maximum Strength
NDC 0363-9130

Generic Name
Acetaminophen, Diphenhydramine Hcl Phenylephrine Hcl
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Sleep Aid
NDC 0363-9236

Generic Name
Diphenhydramine Hcl
Dosage Form
Chewable Gel
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Childrens Daytime Mucus
NDC 0363-9358

Generic Name
Dextromethorphan Hbr
Dosage Form
Chewable Gel
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Childrens Nighttime Mucus
NDC 0363-9360

Generic Name
Dextromethorphan Hbr Doxylamine Succinate
Dosage Form
Chewable Gel
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Daytime Nighttime Chewable
NDC 0363-9393

Generic Name
Dextromethorphan Hbr Doxylamine Succinate
Dosage Form
Kit
Route
N/A
Marketing
OTC MONOGRAPH DRUG
Active Listing

West-Ward Pharmaceuticals Corp

NDC Product
Human Prescription Drug

Ondansetron
NDC 0143-9890

Generic Name
Ondansetron
Dosage Form
Injection
Route
Intramuscular; Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Ondansetron
NDC 0143-9891

Generic Name
Ondansetron
Dosage Form
Injection
Route
Intramuscular; Intravenous
Marketing
ANDA
Active Listing

Xttrium Laboratories, Inc

NDC Product
Human Prescription Drug

Amantadine
NDC 0116-4010

Generic Name
Amantadine
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Xttrium Laboratories, Inc.

NDC Product
Human Prescription Drug

Megestrol Acetate
NDC 0116-4011

Generic Name
Megestrol Acetate
Dosage Form
Suspension
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Promethazine Hydrochloride
NDC 0116-4023

Generic Name
Promethazine Hydrochloride
Dosage Form
Syrup
Route
Oral
Marketing
ANDA
Active Listing

sanofi-aventis U.S. LLC

NDC Product
Human Prescription Drug

Zaltrap
NDC 0024-5840

Generic Name
Ziv-aflibercept
Dosage Form
Solution, Concentrate
Route
Intravenous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Zaltrap
NDC 0024-5841

Generic Name
Ziv-aflibercept
Dosage Form
Solution, Concentrate
Route
Intravenous
Marketing
BLA
Active Listing

External Clinical & Regulatory Resources

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