MONOBASIC POTASSIUM PHOSPHATE
UNII 4J9FJ0HL51

Substance Identification & Data

This profile provides standardized clinical and technical data for Monobasic Potassium Phosphate, uniquely identified by the FDA Unique Ingredient Identifier (UNII) 4J9FJ0HL51.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 7778-77-0 and the RxNorm Concept ID (RxCUI) 55019. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.

FDA UNII Code
4J9FJ0HL51
CAS Registry Number
7778-77-0
RxNorm Concept ID
55019

Detailed Substance Profile

Preferred Name
MONOBASIC POTASSIUM PHOSPHATE
Official standardized name for this substance within the FDA UNII nomenclature system.
Molecular Formula
4J9FJ0HL51
The specific atomic composition represented as a molecular structure string.
InChIKey
K.H2O4P
International Chemical Identifier digital signature for unique molecular identification.
SMILES String
GNSKLFRGEWLPPA-UHFFFAOYSA-M
Line notation for describing the chemical structure and connectivity of atoms.
NCI Thesaurus
C61900
National Cancer Institute reference terminology for clinical and research data.
PubChem CID
24506
Unique identification number in the NCBI database of chemical substances.
Substance Type
chemical
ISO 11238 classification category (e.g., Chemical, Polymer, Protein).
Ingredient Role
P([O-])(=O)(O)O.[K+]

Synonyms and Nomenclature

This section provides a complete list of nomenclature and identifier mappings for Monobasic Potassium Phosphate. 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

MONOBASIC POTASSIUM PHOSPHATE
MONOBASIC POTASSIUM PHOSPHATE [MART.]
MONOBASIC POTASSIUM PHOSPHATE [USP-RS]
PHOSPHORIC ACID, MONOPOTASSIUM SALT
POTASSIUM ACID PHOSPHATE
POTASSIUM BIPHOSPHATE
POTASSIUM DIHYDROGEN PHOSPHATE [EP MONOGRAPH]
POTASSIUM PHOSPHATE MONOBASIC
POTASSIUM PHOSPHATE MONOBASIC (ANHYDROUS)
POTASSIUM PHOSPHATE MONOBASIC [WHO-DD]
POTASSIUM PHOSPHATE, MONOBASIC
POTASSIUM PHOSPHATE, MONOBASIC [FCC]
POTASSIUM PHOSPHATE, MONOBASIC [HSDB]
POTASSIUM PHOSPHATE, MONOBASIC [II]
POTASSIUM PHOSPHATE, MONOBASIC [JAN]
POTASSIUM PHOSPHATE, MONOBASIC [MI]
POTASSIUM PHOSPHATE, MONOBASIC [ORANGE BOOK]
POTASSIUM PHOSPHATE,MONOBASIC [VANDF]
TIS-U-SOL COMPONENT POTASSIUM PHOSPHATE, MONOBASIC

Brand / Trade Names

POTASSIUM PHOSPHATES COMPONENT MONOBASIC POTASSIUM PHOSPHATE

Systematic Nomenclature

MONOPOTASSIUM DIHYDROGEN MONOPHOSPHATE
MONOPOTASSIUM DIHYDROGEN ORTHOPHOSPHATE
MONOPOTASSIUM DIHYDROGEN PHOSPHATE
MONOPOTASSIUM MONOPHOSPHATE
MONOPOTASSIUM ORTHOPHOSPHATE
MONOPOTASSIUM PHOSPHATE
POTASSIUM DIHYDROGEN ORTHOPHOSPHATE
POTASSIUM DIHYDROGEN PHOSPHATE

Technical Codes

E-340(I)
INS NO.340(I)
INS-340(I)

NDC Products Containing MONOBASIC POTASSIUM PHOSPHATE

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 (231), only Active Listings are currently displayed.
→ A-S Medication Solutions 3
→ ATLANTIC BIOLOGICALS CORP. 1
→ Accord Healthcare Inc. 1
→ Acrotech Biopharma Inc 1
→ Alnylam Pharmaceuticals, Inc. 1
→ Altor BioScience, LLC, an indirect wholly-owned subsidiary of ImmunityBio, Inc. 1
→ American Regent, Inc. 3
→ Amneal Pharmaceuticals LLC 2
→ Amneal Pharmaceuticals NY LLC 1
→ Amneal Pharmaceuticals Private Limited 5
→ Atlantic Biologicals Corp 1
→ B. Braun Medical Inc. 1
→ Bamboo US BidCo LLC 1
→ Bausch & Lomb Incorporated 2
→ Bavarian Nordic A/S 1
→ Baxter Healthcare Company 1
→ Baxter Healthcare Corporation 1
→ Beach Products, Inc. 3
→ BioComp Pharma, Inc. 1
→ Biocompatibles, Inc. 2
→ BluePoint Laboratories 3
→ Bryant Ranch Prepack 2
→ Camber Pharmaceuticals, Inc. 1
→ Caplin Steriles Limited 3
→ Cipla USA Inc. 4
→ Derma Care Research Labs, LLC 2
→ Dr. Reddy's Laboratories Inc. 1
→ Dr.Reddy's Laboratories Limited 1
→ Edenbridge Pharmaceuticals LLC. 2
→ Elevate Oral Care 4
→ Eugia US LLC 3
→ Florida Pharmaceutical Products, LLC. 1
→ Fresenius Kabi USA, LLC 5
→ GLENMARK PHARMACEUTICALS INC., USA 3
→ GVS TM INC 1
→ Geiss, Destin & Dunn, Inc 1
→ Genzyme Corporation 2
→ Gland Pharma Limited 1
→ GlaxoSmithKline Biologicals SA 4
→ Hikma Pharmaceuticals USA Inc. 2
→ Hospira, Inc. 1
→ ICU Medical Inc. 1
→ INNOVATIVE SAFETY SUPPLY INC. 1
→ Immedica Pharma US Inc. 2
→ Janssen Products, LP 1
→ Kesin Pharma 1
→ Krystal Biotech, Inc. 1
→ L'Oreal USA Products Inc 3
→ LG H&H Co.,Ltd. 2
→ Lannett Company, Inc. 2
→ MedImmune, LLC 1
→ Meitheal Pharmaceuticals Inc. 3
→ Merck Sharp & Dohme LLC 2
→ Methapharm, Inc 2
→ Mylan Institutional LLC 2
→ Nivagen Pharmaceuticals, Inc. 1
→ Northstar Rx LLC 1
→ Novadoz Pharmaceuticals LLC 3
→ Novartis Pharmaceuticals Corporation 2
→ On Target Laboratories, Inc. 1
→ PAI Holdings, LLC dba PAI Pharma 3
→ PTC Therapeutics, Inc. 1
→ Padagis Israel Pharmaceuticals Ltd 1
→ Pfizer Laboratories Div Pfizer Inc 2
→ Photocure Inc. 1
→ Prasco Laboratories 2
→ Preferred Pharmaceuticals Inc. 1
→ Preferred Pharmaceuticals, Inc. 1
→ Private Beauty Label and Wellness 1
→ Proficient Rx LP 1
→ Qilu Pharmaceutical Co., Ltd. 1
→ REMEDYREPACK INC. 1
→ Redpharm Drug 1
→ Rising Pharma Holdings, Inc. 2
→ Sagent Pharmaceuticals 1
→ Sarepta Therapeutics, Inc. 4
→ Sato Pharmaceutical Co., Ltd. 1
→ Seroyal USA 2
→ Somerset Therapeutics, LLC 3
→ SpecGx LLC 1
→ Sun Pharmaceutical Industries, Inc. 1
→ Tai Guk Pharm. Co., Ltd. 1
→ Tai Guk Pharma. Co., Ltd. 1
→ Takeda Pharmaceuticals America, Inc. 1
→ Tommie Copper, Inc. 3
→ Tonix Medicines, Inc. 1
→ USpharma Ltd 1
→ Upsher-Smith Laboratories, LLC 1
→ Uriel Pharmacy Inc. 1
→ Zyla Life Sciences US LLC 1

A-S Medication Solutions

NDC Product
Human Prescription Drug

Prednisolone Sodium Phosphate
NDC 50090-1582

Generic Name
Prednisolone Sodium Phosphate
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Vaccine

Shingrix
NDC 50090-3372

Generic Name
Zoster Vaccine Recombinant, Adjuvanted
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Vaccine

Shingrix
NDC 50090-7919

Generic Name
Zoster Vaccine Recombinant, Adjuvanted
Dosage Form
Injection, Solution
Route
Intramuscular
Marketing
BLA
Active Listing

ATLANTIC BIOLOGICALS CORP.

NDC Product
Human Prescription Drug

Prednisolone Sodium Phosphate
NDC 17856-0815

Generic Name
Prednisolone Sodium Phosphate
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Accord Healthcare Inc.

NDC Product
Human Prescription Drug

Decitabine
NDC 16729-224

Generic Name
Decitabine
Dosage Form
Injection, Powder, Lyophilized, For Solution
Route
Intravenous
Marketing
ANDA
Active Listing

Acrotech Biopharma Inc

NDC Product
Human Prescription Drug

Zevalin
NDC 72893-007

Generic Name
Ibritumomab Tiuxetan
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing

Alnylam Pharmaceuticals, Inc.

NDC Product
Human Prescription Drug

Onpattro
NDC 71336-1000

Generic Name
Patisiran
Dosage Form
Injection, Lipid Complex
Route
Intravenous
Marketing
NDA
Active Listing

Altor BioScience, LLC, an indirect wholly-owned subsidiary of ImmunityBio, Inc.

NDC Product
Human Prescription Drug

Anktiva
NDC 81481-803

Generic Name
Nogapendekin Alfa Inbakicept-pmln
Dosage Form
Solution
Route
Intravesical
Marketing
BLA
Active Listing

American Regent, Inc.

NDC Product
Human Prescription Drug

Potassium Phosphates
NDC 0517-2051

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

Potassium Phosphates
NDC 0517-2102

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

Potassium Phosphates
NDC 0517-2505

Generic Name
Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
ANDA
Active Listing

Amneal Pharmaceuticals LLC

NDC Product
Human Prescription Drug

Decitabine
NDC 70121-1644

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

Potassium Phosphates
NDC 70121-1722

Generic Name
Potassium Phosphates In Sodium Chloride
Dosage Form
Injection
Route
Intravenous
Marketing
NDA
Active Listing

Amneal Pharmaceuticals NY LLC

NDC Product
Human Prescription Drug

Prednisolone Sodium Phosphate
NDC 69238-2122

Generic Name
Prednisolone Sodium Phosphate
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Amneal Pharmaceuticals Private Limited

NDC Product
Human Prescription Drug

Potassium Phosphates
NDC 80830-1691

Generic Name
Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic ...
Dosage Form
Solution, Concentrate
Route
Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Potassium Phosphates
NDC 80830-1691

Generic Name
Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic ...
Dosage Form
Solution, Concentrate
Route
Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Potassium Phosphates
NDC 80830-1691

Generic Name
Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic ...
Dosage Form
Solution, Concentrate
Route
Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Potassium Phosphates
NDC 80830-1692

Generic Name
Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic ...
Dosage Form
Solution, Concentrate
Route
Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Potassium Phosphates
NDC 80830-1693

Generic Name
Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic ...
Dosage Form
Solution, Concentrate
Route
Intravenous
Marketing
ANDA
Active Listing

Atlantic Biologicals Corp

NDC Product
Human Prescription Drug

Prednisolone Sodium Phosphate
NDC 17856-8815

Generic Name
Prednisolone Sodium Phosphate
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

B. Braun Medical Inc.

NDC Product
Human Prescription Drug

Isolyte S Ph 7.4
NDC 0264-7707

Generic Name
Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium...
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
NDA
Active Listing

Bamboo US BidCo LLC

NDC Product
Vaccine

Flucelvax
NDC 83703-084

Generic Name
Influenza A Virus A/georgia/12/2022 Cvr-167 (h1n1) Antigen (...
Dosage Form
Injection, Suspension
Route
Intramuscular
Marketing
BLA
Active Listing

Bausch & Lomb Incorporated

NDC Product
Human Prescription Drug

Vitrase
NDC 24208-002

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

Levobunolol Hydrochloride
NDC 24208-505

Generic Name
Levobunolol Hydrochloride
Dosage Form
Solution/ Drops
Route
Ophthalmic
Marketing
ANDA
Active Listing

Bavarian Nordic A/S

NDC Product
Vaccine

Vimkunya
NDC 50632-018

Generic Name
Chikungunya Vaccine, Recombinant
Dosage Form
Injection, Suspension
Route
Intramuscular
Marketing
BLA
Active Listing

Baxter Healthcare Company

NDC Product
Human Prescription Drug

Dextrose And Electrolyte No. 48
NDC 0338-0143

Generic Name
Sodium Lactate, Potassium Chloride, Magnesium Chloride, Mono...
Dosage Form
Injection
Route
Intravenous
Marketing
NDA
Active Listing

Baxter Healthcare Corporation

NDC Product
Human Prescription Drug

Tis-u-sol
NDC 0338-0190

Generic Name
Sodium Chloride, Potassium Chloride, Magnesium Sulfate, Sodi...
Dosage Form
Irrigant
Route
Irrigation
Marketing
NDA
Active Listing

Beach Products, Inc.

NDC Product
Human Prescription Drug

K Phos Original
NDC 0486-1111

Generic Name
Potassium Phosphate, Monobasic
Dosage Form
Tablet, Soluble
Route
Oral
Marketing
UNAPPROVED DRUG OTHER
Active Listing
NDC Product
Human Prescription Drug

K Phos Neutral
NDC 0486-1125

Generic Name
Sodium Phosphate, Dibasic, Anhydrous, Potassium Phosphate, M...
Dosage Form
Tablet, Coated
Route
Oral
Marketing
UNAPPROVED DRUG OTHER
Active Listing
NDC Product
Human Prescription Drug

K-phos No. 2
NDC 0486-1134

Generic Name
Potassium Phosphate, Monobasic And Sodium Phosphate, Monobas...
Dosage Form
Tablet, Coated
Route
Oral
Marketing
UNAPPROVED DRUG OTHER
Active Listing

BioComp Pharma, Inc.

Biocompatibles, Inc.

NDC Product
Human Prescription Drug

Varithena
NDC 60635-118

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

Varithena
NDC 60635-133

Generic Name
Polidocanol
Dosage Form
Kit
Route
N/A
Marketing
NDA
Active Listing

BluePoint Laboratories

NDC Product
Human Prescription Drug

Decitabine
NDC 68001-573

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

Decitabine
NDC 68001-618

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

Decitabine
NDC 68001-642

Generic Name
Decitabine
Dosage Form
Injection, Powder, Lyophilized, For Solution
Route
Intravenous
Marketing
ANDA
Active Listing

Bryant Ranch Prepack

NDC Product
Human Prescription Drug

Sumatriptan
NDC 63629-8701

Generic Name
Sumatriptan
Dosage Form
Spray
Route
Nasal
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Sumatriptan
NDC 63629-8703

Generic Name
Sumatriptan
Dosage Form
Spray
Route
Nasal
Marketing
ANDA
Active Listing

Camber Pharmaceuticals, Inc.

NDC Product
Human Prescription Drug

Decitabine
NDC 31722-304

Generic Name
Decitabine
Dosage Form
Injection, Powder, Lyophilized, For Solution
Route
Intravenous
Marketing
ANDA
Active Listing

Caplin Steriles Limited

NDC Product
Human Prescription Drug

Potassium Phosphates
NDC 65145-194

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

Potassium Phosphates
NDC 65145-195

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

Potassium Phosphates
NDC 65145-196

Generic Name
Potassium Phosphates
Dosage Form
Injection, Solution, Concentrate
Route
Intravenous
Marketing
ANDA
Active Listing

Cipla USA Inc.

NDC Product
Human Prescription Drug

Potassium Phosphates
NDC 69097-055

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

Potassium Phosphates
NDC 69097-077

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

Potassium Phosphates
NDC 69097-078

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

Sumatriptan
NDC 69097-644

Generic Name
Sumatriptan
Dosage Form
Spray
Route
Nasal
Marketing
ANDA
Active Listing

Derma Care Research Labs, LLC

NDC Product
Human Otc Drug

Warrior Arthritis Relief
NDC 72839-213

Generic Name
Trolamin Salicylate 10%
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Dch Arthritis Relief
NDC 72839-214

Generic Name
Trolamin Salicylate 10%
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Dr. Reddy's Laboratories Inc.

NDC Product
Human Prescription Drug

Decitabine
NDC 43598-427

Generic Name
Decitabine
Dosage Form
Injection, Powder, Lyophilized, For Solution
Route
Intravenous
Marketing
ANDA
Active Listing

Dr.Reddy's Laboratories Limited

NDC Product
Human Prescription Drug

Decitabine
NDC 55111-556

Generic Name
Decitabine
Dosage Form
Injection, Powder, Lyophilized, For Solution
Route
Intravenous
Marketing
ANDA
Active Listing

Edenbridge Pharmaceuticals LLC.

NDC Product
Human Prescription Drug

Prednisolone Sodium Phosphate
NDC 42799-812

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

Prednisolone Sodium Phosphate
NDC 42799-813

Generic Name
Prednisolone Sodium Phosphate
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Elevate Oral Care

NDC Product
Human Prescription Drug

Fluorimax 5000 Sensitive
NDC 57511-0503

Generic Name
1.1% Sodium Fluoride With 5% Potassium Nitrate Toothpaste
Dosage Form
Paste, Dentifrice
Route
Topical
Marketing
UNAPPROVED DRUG OTHER
Active Listing
NDC Product
Human Prescription Drug

Fluorimax 5000 Sensitive
NDC 57511-0503

Generic Name
1.1% Sodium Fluoride With 5% Potassium Nitrate Toothpaste
Dosage Form
Paste, Dentifrice
Route
Topical
Marketing
UNAPPROVED DRUG OTHER
Active Listing
NDC Product
Human Prescription Drug

Fluorimax 5000
NDC 57511-0504

Generic Name
1.1% Sodium Fluoride Toothpaste
Dosage Form
Paste, Dentifrice
Route
Topical
Marketing
UNAPPROVED DRUG OTHER
Active Listing
NDC Product
Human Prescription Drug

Fluorimax 5000
NDC 57511-0504

Generic Name
1.1% Sodium Fluoride Toothpaste
Dosage Form
Paste, Dentifrice
Route
Topical
Marketing
UNAPPROVED DRUG OTHER
Active Listing

Eugia US LLC

NDC Product
Human Prescription Drug

Isosulfan Blue
NDC 55150-240

Generic Name
Isosulfan Blue
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Isosulfan Blue
NDC 55150-240

Generic Name
Isosulfan Blue
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Decitabine
NDC 55150-376

Generic Name
Decitabine
Dosage Form
Injection, Powder, Lyophilized, For Solution
Route
Intravenous
Marketing
ANDA
Active Listing

Florida Pharmaceutical Products, LLC.

NDC Product
Human Prescription Drug

Sumatriptan
NDC 71921-170

Generic Name
Sumatriptan
Dosage Form
Spray
Route
Nasal
Marketing
ANDA
Active Listing

Fresenius Kabi USA, LLC

NDC Product
Human Prescription Drug

Potassium Phosphates
NDC 65219-052

Generic Name
Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic
Dosage Form
Injection, Solution, Concentrate
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Potassium Phosphates
NDC 65219-054

Generic Name
Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic
Dosage Form
Injection, Solution, Concentrate
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Potassium Phosphates
NDC 65219-056

Generic Name
Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic
Dosage Form
Injection, Solution, Concentrate
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Potassium Phosphates
NDC 65219-656

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

Potassium Phosphates
NDC 65219-658

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

GLENMARK PHARMACEUTICALS INC., USA

NDC Product
Human Prescription Drug

Potassium Phosphates
NDC 68462-786

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

Potassium Phosphates
NDC 68462-787

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

Potassium Phosphates
NDC 68462-788

Generic Name
Potassium Phosphates
Dosage Form
Injection, Solution, Concentrate
Route
Intravenous
Marketing
ANDA
Active Listing

GVS TM INC

NDC Product
Human Prescription Drug

Cp2d
NDC 87069-455

Generic Name
Cp2d
Dosage Form
Solution
Route
Intravenous
Marketing
NDA
Active Listing

Geiss, Destin & Dunn, Inc

NDC Product
Human Otc Drug

Arthritis Relief Goodsense
NDC 50804-207

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

Genzyme Corporation

NDC Product
Human Prescription Drug

Lemtrada
NDC 58468-0200

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

Campath
NDC 58468-0357

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

Gland Pharma Limited

NDC Product
Human Prescription Drug

Decitabine
NDC 68083-528

Generic Name
Decitabine
Dosage Form
Injection, Powder, Lyophilized, For Solution
Route
Intravenous
Marketing
ANDA
Active Listing

GlaxoSmithKline Biologicals SA

NDC Product
Vaccine

Penmenvy
NDC 58160-757

Generic Name
Meningococcal (groups A, B, C, W And Y)
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Vaccine

Shingrix
NDC 58160-823

Generic Name
Zoster Vaccine Recombinant, Adjuvanted
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Vaccine

Arexvy
NDC 58160-848

Generic Name
Respiratory Syncytial Virus Vaccine Recombinant, Adjuvanted
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Vaccine

Menveo
NDC 58160-955

Generic Name
Meningococcal (groups A, C, Y And W-135) Oligosaccharide Dip...
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing

Hikma Pharmaceuticals USA Inc.

NDC Product
Human Prescription Drug

Diskets
NDC 0054-4538

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

Decitabine
NDC 0143-9385

Generic Name
Decitabine
Dosage Form
Injection, Powder, Lyophilized, For Solution
Route
Intravenous
Marketing
ANDA
Active Listing

Hospira, Inc.

NDC Product
Human Prescription Drug

Potassium Phosphates
NDC 0409-0032

Generic Name
Potassium Phosphates
Dosage Form
Injection, Solution, Concentrate
Route
Intravenous
Marketing
ANDA
Active Listing

ICU Medical Inc.

NDC Product
Human Prescription Drug

Ionosol Mb And Dextrose
NDC 0990-7372

Generic Name
Dextrose Monohydrate, Sodium Lactate, Potassium Chloride, Ma...
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
NDA
Active Listing

INNOVATIVE SAFETY SUPPLY INC.

NDC Product
Human Otc Drug

Ph Neutral Emergency Eyewash
NDC 72598-095

Generic Name
Water
Dosage Form
Liquid
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing

Immedica Pharma US Inc.

NDC Product
Human Prescription Drug

Loargys
NDC 81583-102

Generic Name
Pegzilarginase-nbln
Dosage Form
Injection
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Loargys
NDC 81583-105

Generic Name
Pegzilarginase-nbln
Dosage Form
Injection
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing

Janssen Products, LP

NDC Product
Human Prescription Drug

Yondelis
NDC 59676-610

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

Kesin Pharma

NDC Product
Human Prescription Drug

Prednisolone Sodium Phosphate
NDC 81033-021

Generic Name
Prednisolone Sodium Phosphate
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Krystal Biotech, Inc.

NDC Product
Human Prescription Drug

Vyjuvek
NDC 82194-510

Generic Name
Vyjuvek
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing

L'Oreal USA Products Inc

LG H&H Co.,Ltd.

Lannett Company, Inc.

NDC Product
Human Prescription Drug

Sumatriptan
NDC 0527-1818

Generic Name
Sumatriptan
Dosage Form
Spray
Route
Nasal
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Sumatriptan
NDC 0527-1859

Generic Name
Sumatriptan
Dosage Form
Spray
Route
Nasal
Marketing
ANDA
Active Listing

MedImmune, LLC

NDC Product
Vaccine

Flumist
NDC 66019-112

Generic Name
Influenza Vaccine Live Intranasal
Dosage Form
Spray
Route
Nasal
Marketing
BLA
Active Listing

Meitheal Pharmaceuticals Inc.

NDC Product
Human Prescription Drug

Decitabine
NDC 71288-119

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

Decitabine
NDC 71288-119

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

Isosulfan Blue
NDC 71288-805

Generic Name
Isosulfan Blue
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
ANDA
Active Listing

Merck Sharp & Dohme LLC

NDC Product
Vaccine

Proquad
NDC 0006-4171

Generic Name
Measles, Mumps, Rubella And Varicella Virus Vaccine Live
Dosage Form
Injection, Powder, Lyophilized, For Suspension
Route
Intramuscular; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Vaccine

Varivax
NDC 0006-4827

Generic Name
Varicella Virus Vaccine Live
Dosage Form
Injection, Powder, Lyophilized, For Suspension
Route
Subcutaneous
Marketing
BLA
Active Listing

Methapharm, Inc

NDC Product
Human Prescription Drug

Asclera
NDC 67850-140

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

Asclera
NDC 67850-141

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

Mylan Institutional LLC

NDC Product
Human Prescription Drug

Isosulfan Blue
NDC 67457-220

Generic Name
Isosulfan Blue
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Decitabine
NDC 67457-316

Generic Name
Decitabine
Dosage Form
Injection, Powder, Lyophilized, For Solution
Route
Intravenous
Marketing
ANDA
Active Listing

Nivagen Pharmaceuticals, Inc.

NDC Product
Human Prescription Drug

Decitabine
NDC 75834-190

Generic Name
Decitabine
Dosage Form
Injection, Powder, Lyophilized, For Solution
Route
Intravenous
Marketing
ANDA
Active Listing

Northstar Rx LLC

NDC Product
Human Prescription Drug

Decitabine
NDC 72603-107

Generic Name
Decitabine
Dosage Form
Injection, Powder, Lyophilized, For Solution
Route
Intravenous
Marketing
ANDA
Active Listing

Novadoz Pharmaceuticals LLC

NDC Product
Human Prescription Drug

Decitabine
NDC 72205-031

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

Decitabine
NDC 72205-036

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

Isosulfan Blue
NDC 72205-195

Generic Name
Isosulfan Blue
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
ANDA
Active Listing

Novartis Pharmaceuticals Corporation

NDC Product
Human Prescription Drug

Simulect
NDC 0078-0331

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

Simulect
NDC 0078-0393

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

On Target Laboratories, Inc.

NDC Product
Human Prescription Drug

Cytalux
NDC 81052-138

Generic Name
Pafolacianine Injection
Dosage Form
Injection
Route
Intravenous
Marketing
NDA
Active Listing

PAI Holdings, LLC dba PAI Pharma

NDC Product
Human Prescription Drug

Prednisolone Sodium Phosphate
NDC 0121-0759

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

Prednisolone Sodium Phosphate
NDC 0121-0773

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

Prednisolone Sodium Phosphate
NDC 0121-0777

Generic Name
Prednisolone Sodium Phosphate
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

PTC Therapeutics, Inc.

NDC Product
Human Prescription Drug

Kebilidi
NDC 52856-601

Generic Name
Eladocagene Exuparvovec-tneq
Dosage Form
Suspension
Route
Intracerebral
Marketing
BLA
Active Listing

Padagis Israel Pharmaceuticals Ltd

NDC Product
Human Prescription Drug

Sumatriptan
NDC 45802-598

Generic Name
Sumatriptan
Dosage Form
Spray
Route
Nasal
Marketing
ANDA
Active Listing

Pfizer Laboratories Div Pfizer Inc

NDC Product
Vaccine

Ticovac
NDC 0069-0297

Generic Name
Tick-borne Encephalitis Vaccine
Dosage Form
Injection
Route
Intramuscular
Marketing
BLA
Active Listing
NDC Product
Vaccine

Ticovac
NDC 0069-0411

Generic Name
Tick-borne Encephalitis Vaccine
Dosage Form
Injection
Route
Intramuscular
Marketing
BLA
Active Listing

Photocure Inc.

NDC Product
Human Prescription Drug

Cysview
NDC 10511-3001

Generic Name
Hexaminolevulinate Hydrochloride
Dosage Form
Kit
Route
N/A
Marketing
NDA
Active Listing

Prasco Laboratories

NDC Product
Human Prescription Drug

Sumatriptan
NDC 66993-081

Generic Name
Sumatriptan
Dosage Form
Spray
Route
Nasal
Marketing
NDA AUTHORIZED GENERIC
Active Listing
NDC Product
Human Prescription Drug

Sumatriptan
NDC 66993-082

Generic Name
Sumatriptan
Dosage Form
Spray
Route
Nasal
Marketing
NDA AUTHORIZED GENERIC
Active Listing

Preferred Pharmaceuticals Inc.

NDC Product
Human Prescription Drug

Prednisolone Sodium Phosphate
NDC 68788-4046

Generic Name
Prednisolone Sodium Phosphate
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Preferred Pharmaceuticals, Inc.

NDC Product
Human Prescription Drug

Prednisolone Sodium Phosphate
NDC 68788-7708

Generic Name
Prednisolone Sodium Phosphate
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Private Beauty Label and Wellness

NDC Product
Human Otc Drug

Dermachange Arthritis Relief
NDC 83520-214

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

Proficient Rx LP

NDC Product
Human Prescription Drug

Prednisolone Sodium Phosphate
NDC 63187-215

Generic Name
Prednisolone Sodium Phosphate
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Qilu Pharmaceutical Co., Ltd.

NDC Product
Human Prescription Drug

Decitabine
NDC 67184-0535

Generic Name
Decitabine
Dosage Form
Injection, Powder, Lyophilized, For Solution
Route
Intravenous
Marketing
ANDA
Active Listing

REMEDYREPACK INC.

NDC Product
Human Prescription Drug

Prednisolone Sodium Phosphate
NDC 70518-4524

Generic Name
Prednisolone Sodium Phosphate
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Redpharm Drug

NDC Product
Human Prescription Drug

Prednisolone Sodium Phosphate
NDC 67296-2134

Generic Name
Prednisolone Sodium Phosphate
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Rising Pharma Holdings, Inc.

NDC Product
Human Otc Drug

Jointiva
NDC 57237-355

Generic Name
Trolamine Salicylate 10%
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Prescription Drug

Phospha 250 Neutral
NDC 64980-729

Generic Name
Dibasic Sodium Phosphate, Monobasic Potassium Phosphate And ...
Dosage Form
Tablet
Route
Oral
Marketing
UNAPPROVED DRUG OTHER
Active Listing

Sagent Pharmaceuticals

NDC Product
Human Prescription Drug

Decitabine
NDC 25021-219

Generic Name
Decitabine
Dosage Form
Injection, Powder, Lyophilized, For Solution
Route
Intravenous
Marketing
ANDA
Active Listing

Sarepta Therapeutics, Inc.

NDC Product
Human Prescription Drug

Amondys 45
NDC 60923-227

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

Exondys 51
NDC 60923-284

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

Exondys 51
NDC 60923-363

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

Vyondys 53
NDC 60923-465

Generic Name
Golodirsen
Dosage Form
Injection
Route
Intravenous
Marketing
NDA
Active Listing

Sato Pharmaceutical Co., Ltd.

NDC Product
Human Otc Drug

Nazal
NDC 49873-057

Generic Name
Naphazoline Hydrochloride
Dosage Form
Liquid
Route
Nasal
Marketing
OTC MONOGRAPH DRUG
Active Listing

Seroyal USA

NDC Product
Human Otc Drug

Ferrum Phosphoricum 6x
NDC 62106-1053

Generic Name
Hydrated Iron Iii Phosphate
Dosage Form
Tablet
Route
Sublingual
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing
NDC Product
Human Otc Drug

Kalium Phosphoricum 6x
NDC 62106-1055

Generic Name
Potassium Dihydrogen Phosphate
Dosage Form
Tablet
Route
Sublingual
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing

Somerset Therapeutics, LLC

NDC Product
Human Prescription Drug

Isosulfan Blue
NDC 70069-221

Generic Name
Isosulfan Blue
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Potassium Phosphate
NDC 70069-746

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

Potassium Phosphate
NDC 70069-747

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

SpecGx LLC

NDC Product
Human Prescription Drug

Methadone Hydrochloride
NDC 0406-2540

Generic Name
Methadone Hydrochloride
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing

Sun Pharmaceutical Industries, Inc.

NDC Product
Human Prescription Drug

Decitabine
NDC 47335-361

Generic Name
Decitabine
Dosage Form
Kit
Route
N/A
Marketing
NDA
Active Listing

Tai Guk Pharm. Co., Ltd.

Tai Guk Pharma. Co., Ltd.

Takeda Pharmaceuticals America, Inc.

NDC Product
Human Prescription Drug

Kalbitor
NDC 47783-101

Generic Name
Ecallantide
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing

Tommie Copper, Inc.

NDC Product
Human Otc Drug

Copperlife Pain Relief
NDC 72562-123

Generic Name
Trolamine Salicylate 10%
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Tommie Copper Pain Relief
NDC 72562-223

Generic Name
Trolamine Salicylate 10%
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Tonix Medicines, Inc.

NDC Product
Human Prescription Drug

Tosymra
NDC 70792-812

Generic Name
Sumatriptan
Dosage Form
Spray
Route
Nasal
Marketing
NDA
Active Listing

USpharma Ltd

Upsher-Smith Laboratories, LLC

NDC Product
Human Prescription Drug

Tosymra
NDC 0245-0812

Generic Name
Sumatriptan
Dosage Form
Spray
Route
Nasal
Marketing
NDA
Active Listing

Uriel Pharmacy Inc.

NDC Product
Human Otc Drug

Helleborus Comp. A
NDC 48951-5135

Generic Name
Helleborus Comp. A
Dosage Form
Liquid
Route
Oral
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing

Zyla Life Sciences US LLC

NDC Product
Human Prescription Drug

Sprix
NDC 69344-144

Generic Name
Ketorolac Tromethamine
Dosage Form
Spray, Metered
Route
Nasal
Marketing
NDA
Active Listing

External Clinical & Regulatory Resources

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