CITRIC ACID MONOHYDRATE
UNII 2968PHW8QP

Substance Identification & Data

This profile provides standardized clinical and technical data for Citric Acid Monohydrate, uniquely identified by the FDA Unique Ingredient Identifier (UNII) 2968PHW8QP.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 5949-29-1 and the RxNorm Concept ID (RxCUI) 221079. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.

FDA UNII Code
2968PHW8QP
CAS Registry Number
5949-29-1
RxNorm Concept ID
221079

Detailed Substance Profile

Preferred Name
CITRIC ACID MONOHYDRATE
Official standardized name for this substance within the FDA UNII nomenclature system.
Molecular Formula
2968PHW8QP
The specific atomic composition represented as a molecular structure string.
InChIKey
C6H8O7.H2O
International Chemical Identifier digital signature for unique molecular identification.
SMILES String
YASYEJJMZJALEJ-UHFFFAOYSA-N
Line notation for describing the chemical structure and connectivity of atoms.
NCI Thesaurus
C47452
National Cancer Institute reference terminology for clinical and research data.
PubChem CID
22230
Unique identification number in the NCBI database of chemical substances.
Substance Type
chemical
ISO 11238 classification category (e.g., Chemical, Polymer, Protein).
Ingredient Role
C(CC(=O)O)(CC(=O)O)(C(=O)O)O.O

Synonyms and Nomenclature

This section provides a complete list of nomenclature and identifier mappings for Citric Acid Monohydrate. 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.

FDA Official Name

CITRIC ACID

Common Names & Synonyms

1,2,3-PROPANETRICARBOXYLIC ACID, 2 HYDROXY-, MONOHYDRATE
2-HYDROXY-1,2,3-PROPANE-TRICARBOXYLIC ACID, MONOHYDRATE
ACIDUM CITRICUM MONOHYDRATE [WHO-IP LATIN]
B1650 [LANGUAL]
CITRATE [II]
CITRATE [VANDF]
CITRIC ACID [EP MONOGRAPH]
CITRIC ACID [GREEN BOOK]
CITRIC ACID [II]
CITRIC ACID [ORANGE BOOK]
CITRIC ACID [VANDF]
CITRIC ACID BP
CITRIC ACID HYDRATE [JAN]
CITRIC ACID MONOHYDRATE [EP IMPURITY]
CITRIC ACID MONOHYDRATE [EP MONOGRAPH]
CITRIC ACID MONOHYDRATE [II]
CITRIC ACID MONOHYDRATE [MART.]
CITRIC ACID MONOHYDRATE [MI]
CITRIC ACID MONOHYDRATE [USP MONOGRAPH]
CITRIC ACID MONOHYDRATE [VANDF]
CITRIC ACID MONOHYDRATE [WHO-DD]
CITRIC ACID MONOHYDRATE [WHO-IP]
CITRIC ACID, HYDROUS
CITRIC ACID, HYDROUS [II]
CITRIC ACID,HYDROUS
CITRIC ACID,HYDROUS [VANDF]
TAUROLOCK COMPONENT CITRATE

Systematic Nomenclature

2-HYDROXY-1,2,3-PROPANE-TRICARBOXYLIC ACID
CITRATE
CITRIC ACID MONOHYDRATE

Technical Codes

E-330
INS NO.330
INS-330

NDC Products Containing CITRIC ACID MONOHYDRATE

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. 11
→ Alcon Laboratories, Inc. 2
→ Allergan, Inc. 3
→ Amneal Pharmaceuticals of New York LLC 2
→ Bausch Health US LLC 1
→ Bausch Health US, LLC 2
→ Boiron 2
→ C.B. Fleet Company, Inc. 2
→ E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 2
→ E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC 1
→ E.R. Squibb & Sons, L.L.C. 3
→ Fougera Pharmaceuticals, LLC 1
→ GlaxoSmithKline LLC 2
→ Haleon US Holdings LLC 14
→ Hikma Pharmaceuticals USA 2
→ Hikma Pharmaceuticals USA Inc. 23
→ Hikma Pharmaceuticals USA, Inc. 9
→ L Perrigo Company 1
→ L. Perrigo Company 7
→ Laboratoires Boiron 4
→ Merck Sharp & Dohme LLC 11
→ Mission Pharmacal Company 3
→ Novartis Pharmaceuticals Corporation 6
→ PAI Holdings, LLC 3
→ PAI Holdings, LLC dba PAI Pharma 36
→ Parke-Davis Div of Pfizer Inc 1
→ Person and Covey 7
→ Pfizer Laboratories Div Pfizer Inc 4
→ Pharmaceutical Associates, Inc. 3
→ Pharmacia & Upjohn Company LLC 4
→ Roerig 6
→ Teva Pharmaceuticals USA, Inc. 13
→ West-Ward Pharmaceuticals Corp 2
→ Xttrium Laboratories, Inc. 5
→ sanofi-aventis U.S. LLC 2

AbbVie Inc.

NDC Product
Human Prescription Drug

Humira
NDC 0074-0124

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

Humira
NDC 0074-0243

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

Humira
NDC 0074-0554

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

Humira
NDC 0074-0616

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

Humira
NDC 0074-0817

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

Humira
NDC 0074-1539

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

Humira
NDC 0074-2540

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

Humira
NDC 0074-3799

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

Kaletra
NDC 0074-3956

Generic Name
Lopinavir And Ritonavir
Dosage Form
Solution
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Humira
NDC 0074-4339

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

Kaletra
NDC 0074-6799

Generic Name
Lopinavir And Ritonavir
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing

Alcon Laboratories, Inc.

NDC Product
Human Prescription Drug

Betadine
NDC 0065-0411

Generic Name
Povidone-iodine
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 Prescription Drug

Lumigan
NDC 0023-3205

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

Latisse
NDC 0023-3616

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

Amneal Pharmaceuticals of New York LLC

NDC Product
Human Prescription Drug

Budesonide Inhalation
NDC 0115-1687

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

Budesonide Inhalation
NDC 0115-1689

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

Bausch Health US LLC

NDC Product
Human Prescription Drug

Xerese
NDC 0187-5104

Generic Name
Acyclovir And Hydrocortisone
Dosage Form
Cream
Route
Topical
Marketing
NDA
Active Listing

Bausch Health US, LLC

NDC Product
Human Prescription Drug

Zelapar
NDC 0187-0453

Generic Name
Selegiline Hydrochloride
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Caladryl Clear
NDC 0187-5466

Generic Name
Pramoxine Hydrochloride And Zinc Acetate
Dosage Form
Lotion
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Boiron

NDC Product
Human Otc Drug

Arnicare Leg Cramps
NDC 0220-9073

Generic Name
Arnica Montana, Lactic Acid, L-, Zinc Oxide
Dosage Form
Tablet
Route
Oral
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing
NDC Product
Human Otc Drug

Chestal Cold And Cough Honey
NDC 0220-9121

Generic Name
Solanum Dulcamara Top, Ferrosoferric Phosphate, Goldenseal, ...
Dosage Form
Syrup
Route
Oral
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing

C.B. Fleet Company, Inc.

NDC Product
Human Otc Drug

Pedia-lax
NDC 0132-0113

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

Fleet
NDC 0132-0402

Generic Name
Docusate Sodium
Dosage Form
Capsule, Liquid Filled
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

NDC Product
Human Prescription Drug

Clobetasol Propionate (emollient)
NDC 0168-0301

Generic Name
Clobetasol Propionate
Dosage Form
Cream
Route
Topical
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Fluticasone Propionate
NDC 0168-0332

Generic Name
Fluticasone Propionate
Dosage Form
Cream
Route
Topical
Marketing
ANDA
Active Listing

E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC

NDC Product
Human Prescription Drug

Fluocinonide
NDC 0168-0134

Generic Name
Fluocinonide
Dosage Form
Solution
Route
Topical
Marketing
ANDA
Active Listing

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

NDC Product
Human Prescription Drug

Baraclude
NDC 0003-1614

Generic Name
Entecavir
Dosage Form
Solution
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Empliciti
NDC 0003-2291

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

Empliciti
NDC 0003-4522

Generic Name
Elotuzumab
Dosage Form
Injection, Powder, Lyophilized, For Solution
Route
Intravenous
Marketing
BLA
Active Listing

Fougera Pharmaceuticals, LLC

NDC Product
Human Prescription Drug

Fluocinolone Acetonide
NDC 0168-0059

Generic Name
Fluocinolone Acetonide
Dosage Form
Solution
Route
Topical
Marketing
ANDA
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
NDC Product
Human Prescription Drug

Blenrep
NDC 0173-0913

Generic Name
Belantamab Mafodotin
Dosage Form
Injection, Powder, For Solution
Route
Intravenous
Marketing
BLA
Active Listing

Haleon US Holdings LLC

NDC Product
Human Otc Drug

Citrucel
NDC 0135-0089

Generic Name
Methylcellulose
Dosage Form
Powder, For Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Citrucel
NDC 0135-0090

Generic Name
Methylcellulose
Dosage Form
Powder, For Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Tums Chewy Bites
NDC 0135-0183

Generic Name
Calcium Carbonate
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Tums Chewy Bites Berry Shake
NDC 0135-0184

Generic Name
Calcium Carbonate
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Tums Chewy Bites Raspberry Lemonade
NDC 0135-0188

Generic Name
Calcium Carbonate
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Tums Chewy Bites
NDC 0135-0606

Generic Name
Calcium Carbonate
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Tums Chewy Bites
NDC 0135-0618

Generic Name
Calcium Carbonate
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Tums Chewy Bites Peppermint
NDC 0135-0623

Generic Name
Calcium Carbonate
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Tums Chewy Bites With Gas Relief
NDC 0135-0624

Generic Name
Calcium Carbonate And Simethicone
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Tums Chewy Bites Mixed Fruit
NDC 0135-0641

Generic Name
Calcium Carbonate
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Tums Chewy Bites Orange And Cream Es
NDC 0135-0642

Generic Name
Calcium Carbonate
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Hikma Pharmaceuticals USA

NDC Product
Human Prescription Drug

Methadone Hydrochloride
NDC 0054-0391

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

Methadone Hydrochloride
NDC 0054-0392

Generic Name
Methadone Hydrochloride
Dosage Form
Concentrate
Route
Oral
Marketing
ANDA
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

Morphine Sulfate
NDC 0054-0517

Generic Name
Morphine Sulfate
Dosage Form
Solution
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Dicyclomine Hydrochloride
NDC 0054-0622

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

Butorphanol Tartrate
NDC 0054-3090

Generic Name
Butorphanol Tartrate
Dosage Form
Spray, Metered
Route
Nasal
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Methadone Hydrochloride
NDC 0054-3553

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

Prednisone Intensol
NDC 0054-3721

Generic Name
Prednisone Intensol
Dosage Form
Solution, Concentrate
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Prednisone
NDC 0054-3722

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

Propranolol Hydrochloride
NDC 0054-3727

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

Propranolol Hydrochloride
NDC 0054-3730

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

Prednisone
NDC 0054-8724

Generic Name
Prednisone
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Prednisone
NDC 0054-8739

Generic Name
Prednisone
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Prednisone
NDC 0054-8740

Generic Name
Prednisone
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Micafungin
NDC 0143-9361

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

Micafungin
NDC 0143-9362

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

Labetalol Hcl In Sodium Chloride
NDC 0143-9363

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

Labetalol Hcl In Sodium Chloride
NDC 0143-9364

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

Labetalol Hcl In Sodium Chloride
NDC 0143-9365

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

Labetalol Hcl In Dextrose
NDC 0143-9366

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

Etoposide
NDC 0143-9376

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

Etoposide
NDC 0143-9510

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

Etoposide
NDC 0143-9511

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

Etoposide
NDC 0143-9512

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

Linezolid
NDC 0143-9534

Generic Name
Linezolid
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
ANDA
Active Listing

Hikma Pharmaceuticals USA, Inc.

NDC Product
Human Prescription Drug

Dexamethasone Intensol
NDC 0054-3176

Generic Name
Dexamethasone Intensol
Dosage Form
Solution, Concentrate
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Dexamethasone
NDC 0054-3177

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

Dexamethasone
NDC 0054-8174

Generic Name
Dexamethasone
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Dexamethasone
NDC 0054-8175

Generic Name
Dexamethasone
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Dexamethasone
NDC 0054-8176

Generic Name
Dexamethasone
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Dexamethasone
NDC 0054-8179

Generic Name
Dexamethasone
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Dexamethasone
NDC 0054-8180

Generic Name
Dexamethasone
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Dexamethasone
NDC 0054-8181

Generic Name
Dexamethasone
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Dexamethasone
NDC 0054-8183

Generic Name
Dexamethasone
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing

L Perrigo Company

NDC Product
Human Otc Drug

Mederma Pm
NDC 0113-4124

Generic Name
Dimethicone
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

L. Perrigo Company

NDC Product
Human Otc Drug

Nasonex
NDC 0113-1720

Generic Name
Mometasone Furoate
Dosage Form
Spray, Metered
Route
Nasal
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Childrens Nasonex
NDC 0113-1999

Generic Name
Mometasone Furoate
Dosage Form
Spray, Metered
Route
Nasal
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Minoxidil
NDC 0113-5129

Generic Name
Minoxidil
Dosage Form
Aerosol, Foam
Route
Topical
Marketing
ANDA
Active Listing

Laboratoires Boiron

NDC Product
Human Otc Drug

Chestal
NDC 0220-9032

Generic Name
Antimony Potassium Tartrate, Bryonia Alba Root, Protortonia ...
Dosage Form
Syrup
Route
Oral
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing
NDC Product
Human Otc Drug

Chestal For Children
NDC 0220-9033

Generic Name
Antimony Potassium Tartrate, Bryonia Alba Root, Protortonia ...
Dosage Form
Syrup
Route
Oral
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing
NDC Product
Human Otc Drug

Chestal Cough And Cold
NDC 0220-9067

Generic Name
Solanum Dulcamara Top, Ferrum Phosphoricum, Goldenseal, Pota...
Dosage Form
Syrup
Route
Oral
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing
NDC Product
Human Otc Drug

Chestal Childrens Cough And Cold
NDC 0220-9068

Generic Name
Solanum Dulcamara Top, Ferrum Phosphoricum, Goldenseal, Pota...
Dosage Form
Syrup
Route
Oral
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing

Merck Sharp & Dohme LLC

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

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

Tice Bcg
NDC 0052-0602

Generic Name
Bacillus Calmette-guerin
Dosage Form
Powder, For Suspension
Route
Intravesical
Marketing
BLA
Active Listing
NDC Product
Vaccine

Bcg Vaccine
NDC 0052-0603

Generic Name
Bacillus Calmette-guerin Substrain Tice Live Antigen
Dosage Form
Injection, Powder, Lyophilized, For Solution
Route
Percutaneous
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

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

Mission Pharmacal Company

NDC Product
Human Prescription Drug

Ovace Plus
NDC 0178-0485

Generic Name
Sulfacetamide Sodium
Dosage Form
Shampoo
Route
Topical
Marketing
UNAPPROVED DRUG OTHER
Active Listing
NDC Product
Human Prescription Drug

Ovace
NDC 0178-0499

Generic Name
Sulfacetamide Sodium
Dosage Form
Liquid
Route
Topical
Marketing
UNAPPROVED DRUG OTHER
Active Listing
NDC Product
Human Prescription Drug

Ovace Plus
NDC 0178-0630

Generic Name
Sodium Sulfacetamide
Dosage Form
Liquid
Route
Topical
Marketing
UNAPPROVED DRUG OTHER
Active Listing

Novartis Pharmaceuticals Corporation

NDC Product
Human Prescription Drug

Tegretol
NDC 0078-0508

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

Tegretol
NDC 0078-0509

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

Tegretol Xr
NDC 0078-0510

Generic Name
Carbamazepine
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Tegretol Xr
NDC 0078-0511

Generic Name
Carbamazepine
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Tegretol Xr
NDC 0078-0512

Generic Name
Carbamazepine
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Adakveo
NDC 0078-0883

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

PAI Holdings, LLC

NDC Product
Human Otc Drug

Guaifenesin And Codeine Phosphate
NDC 0121-0775

Generic Name
Guaifenesin And Codeine Phosphate
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Guaifenesin And Codeine Phosphate
NDC 0121-1550

Generic Name
Guaifenesin And Codeine Phosphate
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Guaifenesin And Codeine Phosphate
NDC 0121-1775

Generic Name
Guaifenesin And Codeine Phosphate
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

PAI Holdings, LLC dba PAI Pharma

NDC Product
Human Prescription Drug

Diphenhydramine Hydrochloride
NDC 0121-0489

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

Metoclopramide
NDC 0121-0576

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

Guaifenesin Dm
NDC 0121-0638

Generic Name
Guaifenesin And Dextromethorphan
Dosage Form
Syrup
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Prescription Drug

Amantadine Hydrochloride
NDC 0121-0646

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

Acetaminophen
NDC 0121-0657

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

Trihexyphenidyl Hydrochloride
NDC 0121-0658

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

Ethosuximide
NDC 0121-0670

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

Valproic Acid
NDC 0121-0675

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

Potassium Citrate And Citric Acid
NDC 0121-0676

Generic Name
Potassium Citrate And Citric Acid Monohydrate
Dosage Form
Solution
Route
Oral
Marketing
UNAPPROVED DRUG OTHER
Active Listing
NDC Product
Human Prescription Drug

Tricitrates
NDC 0121-0677

Generic Name
Potassium Citrate, Sodium Citrate, And Citric Acid Monohydra...
Dosage Form
Solution
Route
Oral
Marketing
UNAPPROVED DRUG OTHER
Active Listing
NDC Product
Human Prescription Drug

Nortriptyline Hydrochloride
NDC 0121-0678

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

Calcium Carbonate
NDC 0121-0766

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

Levetiracetam
NDC 0121-0799

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

Theophylline
NDC 0121-0820

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

Oxycodone Hydrochloride
NDC 0121-0827

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

Nystatin
NDC 0121-0868

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

Morphine Sulfate
NDC 0121-0904

Generic Name
Morphine Sulfate
Dosage Form
Solution
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Diphenhydramine Hydrochloride
NDC 0121-0978

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

Promethazine Dm
NDC 0121-1070

Generic Name
Promethazine Hydrochloride And Dextromethorphan Hydrobromide
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Brivaracetam
NDC 0121-1074

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

Guaifenesin Dm
NDC 0121-1276

Generic Name
Guaifenesin And Dextromethorphan
Dosage Form
Syrup
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Acetaminophen
NDC 0121-1314

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

Valproic Acid
NDC 0121-1350

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

Metoclopramide
NDC 0121-1576

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

Levetiracetam
NDC 0121-1598

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

Childrens Acetaminophen
NDC 0121-1781

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

Acetaminophen
NDC 0121-1971

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

Levetiracetam
NDC 0121-2397

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

Valproic Acid
NDC 0121-4675

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

Calcium Carbonate
NDC 0121-4766

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

Levetiracetam
NDC 0121-4799

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

Theophylline
NDC 0121-4820

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

Oxycodone Hydrochloride
NDC 0121-4827

Generic Name
Oxycodone Hydrochloride
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Parke-Davis Div of Pfizer Inc

NDC Product
Human Prescription Drug

Zarontin
NDC 0071-2418

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

Person and Covey

NDC Product
Human Otc Drug

Solbar Sunscreen 40 Zinc
NDC 0096-0691

Generic Name
Sunscreen
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Solbar Sunscreen 40 Shield
NDC 0096-0692

Generic Name
Sunscreen
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Solbar Sunscreen 50 Fifty
NDC 0096-0693

Generic Name
Sunscreen
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Dhs Body Wash
NDC 0096-0742

Generic Name
Zinc Pyrithione
Dosage Form
Liquid
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Dhs Zinc
NDC 0096-0811

Generic Name
Pyrithione Zinc
Dosage Form
Shampoo
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Dhs Tar
NDC 0096-0813

Generic Name
Coal Tar
Dosage Form
Shampoo
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Dhs Body Wash
NDC 0096-0814

Generic Name
Zinc Pyrithione Wash
Dosage Form
Liquid
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Pfizer Laboratories Div Pfizer Inc

NDC Product
Human Prescription Drug

Zithromax
NDC 0069-0400

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

Zithromax
NDC 0069-3150

Generic Name
Azithromycin Dihydrate
Dosage Form
Injection, Powder, Lyophilized, For Solution
Route
Intravenous
Marketing
NDA
Active Listing

Pharmaceutical Associates, Inc.

NDC Product
Human Prescription Drug

Nystatin
NDC 0121-0810

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

Propranolol Hydrochloride
NDC 0121-0908

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

Nystatin
NDC 0121-4810

Generic Name
Nystatin
Dosage Form
Suspension
Route
Oral
Marketing
ANDA
Active Listing

Pharmacia & Upjohn Company LLC

NDC Product
Human Prescription Drug

Zyvox
NDC 0009-5136

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

Zyvox
NDC 0009-5140

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

Nicotrol
NDC 0009-5401

Generic Name
Nicotine
Dosage Form
Spray, Metered
Route
Nasal
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Zyvox
NDC 0009-7807

Generic Name
Linezolid
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
NDA
Active Listing

Roerig

NDC Product
Human Prescription Drug

Pfizerpen
NDC 0049-0420

Generic Name
Penicillin G Potassium
Dosage Form
Powder, For Solution
Route
Intramuscular; Intrapleural; Intrathecal; Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Pfizerpen
NDC 0049-0430

Generic Name
Penicillin G Potassium
Dosage Form
Powder, For Solution
Route
Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Pfizerpen
NDC 0049-0520

Generic Name
Penicillin G Potassium
Dosage Form
Powder, For Solution
Route
Intramuscular; Intrapleural; Intrathecal; Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Pfizerpen
NDC 0049-0520

Generic Name
Penicillin G Potassium
Dosage Form
Powder, For Solution
Route
Intramuscular; Intrapleural; Intrathecal; Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Pfizerpen
NDC 0049-0530

Generic Name
Penicillin G Potassium
Dosage Form
Powder, For Solution
Route
Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Pfizerpen
NDC 0049-0530

Generic Name
Penicillin G Potassium
Dosage Form
Powder, For Solution
Route
Intravenous
Marketing
ANDA
Active Listing

Teva Pharmaceuticals USA, Inc.

NDC Product
Human Prescription Drug

Fluocinonide
NDC 0093-0262

Generic Name
Fluocinonide
Dosage Form
Cream
Route
Topical
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Fluocinonide
NDC 0093-0263

Generic Name
Fluocinonide
Dosage Form
Cream
Route
Topical
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Fluocinonide
NDC 0093-0264

Generic Name
Fluocinonide
Dosage Form
Ointment
Route
Topical
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Buprenorphine
NDC 0093-3656

Generic Name
Buprenorphine
Dosage Form
Patch, Extended Release
Route
Transdermal
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Buprenorphine
NDC 0093-3657

Generic Name
Buprenorphine
Dosage Form
Patch, Extended Release
Route
Transdermal
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Buprenorphine
NDC 0093-3658

Generic Name
Buprenorphine
Dosage Form
Patch, Extended Release
Route
Transdermal
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Buprenorphine
NDC 0093-3659

Generic Name
Buprenorphine
Dosage Form
Patch, Extended Release
Route
Transdermal
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Formoterol Fumarate
NDC 0093-4061

Generic Name
Formoterol Fumarate
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

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 Otc Drug

Dyna-hex 2
NDC 0116-1021

Generic Name
Chlorhexidine Gluconate
Dosage Form
Liquid
Route
Topical
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Dyna-hex 2
NDC 0116-1022

Generic Name
Chlorhexidine Gluconate 2%
Dosage Form
Solution
Route
Topical
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Dyna-hex 2
NDC 0116-1022

Generic Name
Chlorhexidine Gluconate 2%
Dosage Form
Solution
Route
Topical
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Lidocaine Hydrochloride
NDC 0116-4027

Generic Name
Lidocaine Hydrochloride
Dosage Form
Solution
Route
Oral; Topical
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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