METHIONINE
UNII AE28F7PNPL

Substance Identification & Data

This profile provides standardized clinical and technical data for Methionine, uniquely identified by the FDA Unique Ingredient Identifier (UNII) AE28F7PNPL.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 63-68-3 and the RxNorm Concept ID (RxCUI) 6837. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.

FDA UNII Code
AE28F7PNPL
CAS Registry Number
63-68-3
RxNorm Concept ID
6837

Detailed Substance Profile

Preferred Name
METHIONINE
Official standardized name for this substance within the FDA UNII nomenclature system.
Molecular Formula
AE28F7PNPL
The specific atomic composition represented as a molecular structure string.
InChIKey
C5H11NO2S
International Chemical Identifier digital signature for unique molecular identification.
SMILES String
FFEARJCKVFRZRR-BYPYZUCNSA-N
Line notation for describing the chemical structure and connectivity of atoms.
NCI Thesaurus
C29600
National Cancer Institute reference terminology for clinical and research data.
PubChem CID
6137
Unique identification number in the NCBI database of chemical substances.
INN ID
452
Sequential identifier assigned via the WHO International Nonproprietary Name program.
Substance Type
chemical
ISO 11238 classification category (e.g., Chemical, Polymer, Protein).
Ingredient Role
C(=O)([C@@H](N)CCSC)O

Synonyms and Nomenclature

This section provides a complete list of nomenclature and identifier mappings for Methionine. 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

METHIONINE

Common Names & Synonyms

LEUCINE IMPURITY B [EP IMPURITY]
L-METHIONINE [FCC]
L-METHIONINE [JAN]
L-METHIONINE [USP-RS]
METHIONINE [EP MONOGRAPH]
METHIONINE [HSDB]
METHIONINE [II]
METHIONINE [INN]
METHIONINE [MART.]
METHIONINE [MI]
METHIONINE [USAN]
METHIONINE [USP MONOGRAPH]
METHIONINE [VANDF]
METHIONINE [WHO-DD]

Systematic Nomenclature

(2S)-2-AMINO-4-(METHYLSULFANYL)BUTANOIC ACID
L-METHIONINE

Technical Codes

NSC-22946

NDC Products Containing METHIONINE

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 (289), only Active Listings are currently displayed.
→ AMOREPACIFIC CORPORATION 2
→ Abeona Therapeutics Inc. 1
→ Accord BioPharma Inc. 1
→ Antares Pharma, Inc. 1
→ B. Braun Medical Inc. 2
→ Baxter Healthcare Company 10
→ Baxter Healthcare Corporation 13
→ BioActive Nutritional, Inc. 1
→ Biocon Biologics Inc 3
→ Biocon Biologics Inc. 2
→ Bracco Diagnostics Inc. 1
→ CELLTRION USA, Inc. 1
→ CIVICA, INC. 2
→ CellTrans Inc. 1
→ Citius Pharmaceuticals, Inc. 1
→ Denali Therapeutics Inc. 1
→ Deseret Biologicals, Inc. 1
→ Domp� farmaceutici S.p.A. 2
→ E.R. Squibb & Sons, L.L.C. 1
→ EMD Serono, Inc. 4
→ Energique, Inc. 1
→ FOSUN PHARMA USA INC 1
→ Fresenius Kabi USA, LLC 4
→ Genentech, Inc. 15
→ Genzyme Corporation 1
→ Golden State Medical Supply, Inc. 1
→ Guna spa 1
→ HF Acquisition Co LLC, DBA HealthFirst 1
→ Hikma Pharmaceuticals USA Inc. 1
→ ICU Medical Inc. 4
→ Invivyd, Inc 1
→ Janssen Biotech, Inc. 8
→ Kyowa Kirin, Inc. 3
→ Liddell Laboratories, Inc. 1
→ MAIA Pharmaceuticals, Inc. 1
→ McKesson 5
→ Merck Sharp & Dohme LLC 2
→ Novartis Pharmaceuticals Corporation 2
→ Novo Nordisk 19
→ Nutritional Specialties, Inc. 2
→ Nuvaila Limited 4
→ Organon LLC 3
→ Pfizer Laboratories Div Pfizer Inc 5
→ Pharmacia & Upjohn Company LLC 1
→ Professional Complementary Health Formulas 3
→ Quallent Pharmaceuticals Health LLC 1
→ SANDOZ INC 1
→ Sanofi-Aventis U.S. LLC 1
→ Slayback Pharma LLC 2
→ TerSera Therapeutics LLC 3
→ Teva Pharmaceuticals USA, Inc. 2
→ Teva Pharmaceuticals, Inc. 3
→ Vifor (International) Inc. 9
→ Wilshire Pharmaceuticals, Inc. 2
→ argenx US 1

AMOREPACIFIC CORPORATION

NDC Product
Human Otc Drug

Iope Air Cushion Cover 21 Vanilla
NDC 43419-404

Generic Name
Zinc Oxide, Octinoxate, And Titanium Dioxide
Dosage Form
Lotion
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Iope Air Cushion Cover 23 Beige
NDC 43419-405

Generic Name
Zinc Oxide, Octinoxate, And Titanium Dioxide
Dosage Form
Lotion
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Abeona Therapeutics Inc.

NDC Product
Human Prescription Drug

Zevaskyn
NDC 84103-007

Generic Name
Prademagene Zamikeracel
Dosage Form
Cellular Sheet
Route
Topical
Marketing
BLA
Active Listing

Accord BioPharma Inc.

NDC Product
Human Prescription Drug

Imuldosa
NDC 69448-019

Generic Name
Ustekinumab-srlf
Dosage Form
Injection
Route
Intravenous
Marketing
BLA
Active Listing

Antares Pharma, Inc.

NDC Product
Human Prescription Drug

Hylenex Recombinant
NDC 18657-117

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

B. Braun Medical Inc.

NDC Product
Human Prescription Drug

Trophamine
NDC 0264-1933

Generic Name
Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalani...
Dosage Form
Solution
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Plenamine
NDC 0264-4500

Generic Name
Lysine Acetate, Leucine, Phenylalanine, Valine, Isoleucine, ...
Dosage Form
Solution
Route
Intravenous
Marketing
ANDA
Active Listing

Baxter Healthcare Company

NDC Product
Human Prescription Drug

Clinimix E
NDC 0338-1113

Generic Name
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Vali...
Dosage Form
Injection
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Clinimix E
NDC 0338-1115

Generic Name
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Vali...
Dosage Form
Injection
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Clinimix E
NDC 0338-1123

Generic Name
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Vali...
Dosage Form
Injection
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Clinimix E
NDC 0338-1125

Generic Name
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Vali...
Dosage Form
Injection
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Premasol - Sulfite-free (amino Acid)
NDC 0338-1130

Generic Name
Leucine, Lysine, Isoleucine, Valine, Histidine, Phenylalanin...
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Clinimix E
NDC 0338-1142

Generic Name
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Vali...
Dosage Form
Injection
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Clinimix E
NDC 0338-1144

Generic Name
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Vali...
Dosage Form
Injection
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Clinimix E
NDC 0338-1145

Generic Name
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Vali...
Dosage Form
Injection
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Clinimix E
NDC 0338-1147

Generic Name
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Vali...
Dosage Form
Injection
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Clinimix E
NDC 0338-1148

Generic Name
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Vali...
Dosage Form
Injection
Route
Intravenous
Marketing
NDA
Active Listing

Baxter Healthcare Corporation

NDC Product
Human Prescription Drug

Prosol
NDC 0338-0499

Generic Name
Valine, Lysine, Histidine, Isoleucine, Leucine, Phenylalanin...
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Clinisol
NDC 0338-0502

Generic Name
Lysine, Leucine, Phenylalanine, Valine, Histidine, Isoleucin...
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Travasol
NDC 0338-0644

Generic Name
Leucine, Phenylalanine, Lysine Hydrochloride, Methionine, Is...
Dosage Form
Injection
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Clinimix
NDC 0338-1089

Generic Name
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Vali...
Dosage Form
Injection
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Clinimix
NDC 0338-1091

Generic Name
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Vali...
Dosage Form
Injection
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Clinimix
NDC 0338-1099

Generic Name
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Vali...
Dosage Form
Injection
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Clinimix
NDC 0338-1101

Generic Name
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Vali...
Dosage Form
Injection
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Clinimix
NDC 0338-1133

Generic Name
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Vali...
Dosage Form
Injection
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Clinimix
NDC 0338-1134

Generic Name
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Vali...
Dosage Form
Injection
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Clinimix
NDC 0338-1137

Generic Name
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Vali...
Dosage Form
Injection
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Clinimix
NDC 0338-1138

Generic Name
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Vali...
Dosage Form
Injection
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Epinephrine
NDC 43066-801

Generic Name
Epinephrine
Dosage Form
Injection, Solution, Concentrate
Route
Intramuscular; Intravenous; Subcutaneous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Epinephrine
NDC 43066-803

Generic Name
Epinephrine
Dosage Form
Injection, Solution, Concentrate
Route
Intramuscular; Intravenous; Subcutaneous
Marketing
NDA
Active Listing

BioActive Nutritional, Inc.

NDC Product
Human Otc Drug

Metalogin
NDC 43857-0617

Generic Name
Allium Sativum, Berberis Vulgaris, Glycyrrhiza Glabra, Lappa...
Dosage Form
Liquid
Route
Oral
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing

Biocon Biologics Inc

NDC Product
Human Prescription Drug

Adalimumab
NDC 83257-020

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

Adalimumab
NDC 83257-021

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

Adalimumab
NDC 83257-022

Generic Name
Adalimumab-fkjp
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing

Biocon Biologics Inc.

NDC Product
Human Prescription Drug

Yesintek
NDC 83257-023

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

Yesintek
NDC 83257-026

Generic Name
Ustekinumab
Dosage Form
Solution
Route
Intravenous
Marketing
BLA
Active Listing

Bracco Diagnostics Inc.

NDC Product
Human Prescription Drug

Kinevac
NDC 0270-0556

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

CELLTRION USA, Inc.

NDC Product
Human Prescription Drug

Steqeyma
NDC 72606-029

Generic Name
Ustekinumab-stba
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
BLA
Active Listing

CIVICA, INC.

NDC Product
Human Prescription Drug

Dexmedetomidine Hydrochloride
NDC 72572-127

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

Dexmedetomidine Hydrochloride
NDC 72572-128

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

CellTrans Inc.

NDC Product
Cellular Therapy

Lantidra
NDC 73539-001

Generic Name
Donislecel
Dosage Form
Solution
Route
Intravascular
Marketing
BLA
Active Listing

Citius Pharmaceuticals, Inc.

NDC Product
Human Prescription Drug

Lymphir
NDC 52658-7777

Generic Name
Denileukin Diftitox-cxdl
Dosage Form
Injection, Powder, Lyophilized, For Solution
Route
Intravenous
Marketing
BLA
Active Listing

Denali Therapeutics Inc.

NDC Product
Human Prescription Drug

Avlayah
NDC 84976-001

Generic Name
Tividenofusp Alfa-eknm
Dosage Form
Injection, Powder, Lyophilized, For Solution
Route
Intravenous
Marketing
BLA
Active Listing

Deseret Biologicals, Inc.

NDC Product
Human Otc Drug

Metox
NDC 43742-2221

Generic Name
Allium Sativum, Arsenicum Album, Ascorbicum Acidum, Berberis...
Dosage Form
Liquid
Route
Oral
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing

Domp� farmaceutici S.p.A.

NDC Product
Human Prescription Drug

Oxervate
NDC 71981-001

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

Oxervate
NDC 71981-020

Generic Name
Cenegermin-bkbj
Dosage Form
Solution/ Drops
Route
Ophthalmic
Marketing
BLA
Active Listing

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

NDC Product
Human Prescription Drug

Opdivo Qvantig
NDC 0003-6120

Generic Name
Nivolumab And Hyaluronidase-nvhy
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing

EMD Serono, Inc.

NDC Product
Human Prescription Drug

Gonal-f Rff Redi-ject
NDC 44087-1115

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

Gonal-f Rff Redi-ject
NDC 44087-1116

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

Gonal-f Rff Redi-ject
NDC 44087-1117

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

Ovidrel
NDC 44087-1150

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

Energique, Inc.

NDC Product
Human Otc Drug

Metabatone
NDC 44911-0665

Generic Name
Aralia Racemosa, Avena Sativa, Berberis Vulgaris, Capsicum A...
Dosage Form
Liquid
Route
Oral
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing

FOSUN PHARMA USA INC

NDC Product
Human Prescription Drug

Sincalide
NDC 72266-248

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

Fresenius Kabi USA, LLC

NDC Product
Human Prescription Drug

Sincalide
NDC 63323-579

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

Kabiven
NDC 63323-712

Generic Name
Dextrose, Soybean Oil, Electrolytes, Lysine, Phenylalanine, ...
Dosage Form
Injection, Emulsion
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Perikabiven
NDC 63323-714

Generic Name
Dextrose, Soybean Oil, Electrolytes, Lysine, Phenylalanine, ...
Dosage Form
Injection, Emulsion
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Otulfi
NDC 65219-828

Generic Name
Ustekinumab-aauz
Dosage Form
Solution
Route
Intravenous
Marketing
BLA
Active Listing

Genentech, Inc.

NDC Product
Human Prescription Drug

Herceptin Hylecta
NDC 50242-077

Generic Name
Trastuzumab And Hyaluronidase-oysk
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Vabysmo
NDC 50242-096

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

Rituxan Hycela
NDC 50242-108

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

Rituxan Hycela
NDC 50242-109

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

Columvi
NDC 50242-125

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

Columvi
NDC 50242-127

Generic Name
Glofitamab
Dosage Form
Concentrate
Route
Intravenous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Actemra
NDC 50242-138

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

Lunsumio
NDC 50242-142

Generic Name
Mosunetuzumab
Dosage Form
Concentrate
Route
Intravenous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Lunsumio
NDC 50242-159

Generic Name
Mosunetuzumab
Dosage Form
Concentrate
Route
Intravenous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Lunsumio Velo
NDC 50242-177

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

Lunsumio Velo
NDC 50242-201

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

Phesgo
NDC 50242-245

Generic Name
Pertuzumab, Trastuzumab, And Hyaluronidase-zzxf
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Phesgo
NDC 50242-260

Generic Name
Pertuzumab, Trastuzumab, And Hyaluronidase-zzxf
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Ocrevus Zunovo
NDC 50242-554

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

Tecentriq Hybreza
NDC 50242-933

Generic Name
Atezolizumab And Hyaluronidase-tqjs
Dosage Form
Injection
Route
Subcutaneous
Marketing
BLA
Active Listing

Genzyme Corporation

NDC Product
Human Prescription Drug

Xenpozyme
NDC 58468-0050

Generic Name
Olipudase Alfa-rpcp
Dosage Form
Injection, Powder, Lyophilized, For Solution
Route
Intravenous
Marketing
BLA
Active Listing

Golden State Medical Supply, Inc.

NDC Product
Human Prescription Drug

Imuldosa
NDC 51407-931

Generic Name
Ustekinumab-srlf
Dosage Form
Injection
Route
Intravenous
Marketing
BLA
Active Listing

Guna spa

NDC Product
Human Otc Drug

Osteobios
NDC 17089-259

Generic Name
Calcitonin Human - Calcium Carbonate - Calcium Fluoride - Ca...
Dosage Form
Solution/ Drops
Route
Oral
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing

HF Acquisition Co LLC, DBA HealthFirst

NDC Product
Human Prescription Drug

Hyaluronidase
NDC 51662-1555

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

Hikma Pharmaceuticals USA Inc.

NDC Product
Human Prescription Drug

Starjemza
NDC 0143-9171

Generic Name
Ustekinumab-hmny
Dosage Form
Injection
Route
Intravenous
Marketing
BLA
Active Listing

ICU Medical Inc.

NDC Product
Human Prescription Drug

Aminosyn-pf
NDC 0990-4178

Generic Name
Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalani...
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Aminosyn-pf
NDC 0990-4179

Generic Name
Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalani...
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Aminosyn Ii
NDC 0990-7171

Generic Name
Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalani...
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Aminosyn Ii
NDC 0990-7172

Generic Name
Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalani...
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
NDA
Active Listing

Invivyd, Inc

NDC Product
Human Prescription Drug

Pemgarda
NDC 81960-031

Generic Name
Pemivibart
Dosage Form
Injection
Route
Intravenous
Marketing
EMERGENCY USE AUTHORIZATION
Active Listing

Janssen Biotech, Inc.

NDC Product
Human Prescription Drug

Stelara
NDC 57894-054

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

Ustekinumab
NDC 57894-444

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

Rybrevant
NDC 57894-501

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

Darzalex Faspro
NDC 57894-503

Generic Name
Daratumumab And Hyaluronidase-fihj (human Recombinant)
Dosage Form
Injection
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Rybrevant Faspro
NDC 57894-510

Generic Name
Amivantamab And Hyaluronidase-lpuj (human Recombinant)
Dosage Form
Injection
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Rybrevant Faspro
NDC 57894-514

Generic Name
Amivantamab And Hyaluronidase-lpuj (human Recombinant)
Dosage Form
Injection
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Imaavy
NDC 57894-800

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

Imaavy
NDC 57894-801

Generic Name
Nipocalimab
Dosage Form
Injection, Solution, Concentrate
Route
Intravenous
Marketing
BLA
Active Listing

Kyowa Kirin, Inc.

NDC Product
Human Prescription Drug

Crysvita
NDC 42747-102

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

Crysvita
NDC 42747-203

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

Crysvita
NDC 42747-304

Generic Name
Burosumab
Dosage Form
Injection
Route
Subcutaneous
Marketing
BLA
Active Listing

Liddell Laboratories, Inc.

NDC Product
Human Otc Drug

Vital Skin Hair Nails
NDC 50845-0278

Generic Name
L-alanine, L-arginine, L-carnitine, Cysteinum, L-glutamine, ...
Dosage Form
Spray
Route
Oral
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing

MAIA Pharmaceuticals, Inc.

NDC Product
Human Prescription Drug

Sincalide
NDC 70511-131

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

McKesson

NDC Product
Human Otc Drug

Antifungal Body
NDC 68599-0206

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

Dimethicone
NDC 68599-0212

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

Dimethicone
NDC 68599-0213

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

Antimicrobial
NDC 68599-0214

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

Dimethicone
NDC 68599-0218

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

Merck Sharp & Dohme LLC

NDC Product
Human Prescription Drug

Keytruda Qlex
NDC 0006-3083

Generic Name
Pembrolizumab And Berahyaluronidase Alfa-pmph
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Keytruda Qlex
NDC 0006-5083

Generic Name
Pembrolizumab And Berahyaluronidase Alfa-pmph
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing

Novartis Pharmaceuticals Corporation

NDC Product
Human Prescription Drug

Cosentyx
NDC 0078-0639

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

Cosentyx
NDC 0078-1056

Generic Name
Secukinumab
Dosage Form
Injection
Route
Subcutaneous
Marketing
BLA
Active Listing

Novo Nordisk

NDC Product
Plasma Derivative

Novoseven Rt
NDC 0169-7010

Generic Name
Coagulation Factor Viia (recombinant)
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Plasma Derivative

Novoseven Rt
NDC 0169-7020

Generic Name
Coagulation Factor Viia (recombinant)
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Plasma Derivative

Novoseven Rt
NDC 0169-7040

Generic Name
Coagulation Factor Viia (recombinant)
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Plasma Derivative

Novoseven Rt
NDC 0169-7050

Generic Name
Coagulation Factor Viia (recombinant)
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Plasma Derivative

Novoseven Rt
NDC 0169-7201

Generic Name
Coagulation Factor Viia (recombinant)
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Plasma Derivative

Novoseven Rt
NDC 0169-7202

Generic Name
Coagulation Factor Viia (recombinant)
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Plasma Derivative

Novoseven Rt
NDC 0169-7205

Generic Name
Coagulation Factor Viia (recombinant)
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Plasma Derivative

Novoseven Rt
NDC 0169-7208

Generic Name
Coagulation Factor Viia (recombinant)
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Plasma Derivative

Novoeight
NDC 0169-7810

Generic Name
Antihemophilic Factor Recombinant
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Plasma Derivative

Novoeight
NDC 0169-7815

Generic Name
Antihemophilic Factor Recombinant
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Plasma Derivative

Novoeight
NDC 0169-7820

Generic Name
Antihemophilic Factor Recombinant
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Plasma Derivative

Novoeight
NDC 0169-7825

Generic Name
Antihemophilic Factor Recombinant
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Plasma Derivative

Novoeight
NDC 0169-7830

Generic Name
Antihemophilic Factor Recombinant
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Plasma Derivative

Novoeight
NDC 0169-7850

Generic Name
Antihemophilic Factor Recombinant
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Plasma Derivative

Esperoct
NDC 0169-8100

Generic Name
Antihemophilic Factor (recombinant), Glycopegylated-exei
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Plasma Derivative

Esperoct
NDC 0169-8150

Generic Name
Antihemophilic Factor (recombinant), Glycopegylated-exei
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Plasma Derivative

Esperoct
NDC 0169-8200

Generic Name
Antihemophilic Factor (recombinant), Glycopegylated-exei
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Plasma Derivative

Esperoct
NDC 0169-8300

Generic Name
Antihemophilic Factor (recombinant), Glycopegylated-exei
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Plasma Derivative

Esperoct
NDC 0169-8500

Generic Name
Antihemophilic Factor (recombinant), Glycopegylated-exei
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing

Nutritional Specialties, Inc.

NDC Product
Human Otc Drug

Methylation Assist Liquescence
NDC 83027-0095

Generic Name
Inositol, Methylcobalamin (vitamin B12), Nadidum (nadh), Nia...
Dosage Form
Liquid
Route
Oral
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing
NDC Product
Human Otc Drug

Metab
NDC 83027-0116

Generic Name
Calcarea Sulphurica, Kali Muriaticum, Kali Phosphoricum, Kal...
Dosage Form
Spray
Route
Oral
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing

Nuvaila Limited

NDC Product
Human Prescription Drug

Wezlana
NDC 84612-066

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

Wezlana
NDC 84612-855

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

Wezlana
NDC 84612-876

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

Wezlana
NDC 84612-889

Generic Name
Ustekinumab-auub
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing

Organon LLC

NDC Product
Human Prescription Drug

Follistim Aq
NDC 78206-129

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

Follistim Aq
NDC 78206-130

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

Follistim Aq
NDC 78206-131

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

Pfizer Laboratories Div Pfizer Inc

NDC Product
Human Prescription Drug

Abrilada
NDC 0025-0325

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

Abrilada
NDC 0025-0328

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

Abrilada
NDC 0025-0333

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

Retacrit
NDC 0069-1311

Generic Name
Epoetin Alfa-epbx
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Retacrit
NDC 0069-1318

Generic Name
Epoetin Alfa-epbx
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing

Pharmacia & Upjohn Company LLC

NDC Product
Human Prescription Drug

Depo-subq Provera
NDC 0009-4709

Generic Name
Medroxyprogesterone Acetate
Dosage Form
Injection, Suspension
Route
Subcutaneous
Marketing
NDA
Active Listing

Professional Complementary Health Formulas

NDC Product
Human Otc Drug

Same Liquescence 3036
NDC 63083-3036

Generic Name
Same Liquescence
Dosage Form
Liquid
Route
Oral
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing
NDC Product
Human Otc Drug

L-methionine 7417
NDC 63083-7417

Generic Name
L-methionine
Dosage Form
Liquid
Route
Oral
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing
NDC Product
Human Otc Drug

L-methionine High 7418
NDC 63083-7418

Generic Name
L-methionine High
Dosage Form
Liquid
Route
Oral
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing

Quallent Pharmaceuticals Health LLC

NDC Product
Human Prescription Drug

Ustekinumab-ttwe
NDC 82009-163

Generic Name
Ustekinumab-ttwe
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
BLA
Active Listing

SANDOZ INC

NDC Product
Human Prescription Drug

Pyzchiva
NDC 61314-654

Generic Name
Ustekinumab-ttwe
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
BLA
Active Listing

Sanofi-Aventis U.S. LLC

NDC Product
Human Prescription Drug

Soliqua 100/33
NDC 0024-5761

Generic Name
Insulin Glargine And Lixisenatide
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing

Slayback Pharma LLC

NDC Product
Human Prescription Drug

Dexmedetomidine Hydrochloride
NDC 71225-132

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

Dexmedetomidine Hydrochloride
NDC 71225-133

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

TerSera Therapeutics LLC

NDC Product
Human Prescription Drug

Prialt
NDC 70720-720

Generic Name
Ziconotide Acetate
Dosage Form
Injection, Solution
Route
Intrathecal
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Prialt
NDC 70720-722

Generic Name
Ziconotide Acetate
Dosage Form
Injection, Solution
Route
Intrathecal
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Prialt
NDC 70720-723

Generic Name
Ziconotide Acetate
Dosage Form
Injection, Solution
Route
Intrathecal
Marketing
NDA
Active Listing

Teva Pharmaceuticals USA, Inc.

NDC Product
Human Prescription Drug

Selarsdi
NDC 51759-505

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

Selarsdi
NDC 51759-708

Generic Name
Ustekinumab-aekn
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
BLA
Active Listing

Teva Pharmaceuticals, Inc.

NDC Product
Human Prescription Drug

Pemetrexed
NDC 0480-4514

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

Pemetrexed
NDC 0480-4515

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

Pemetrexed
NDC 0480-4516

Generic Name
Pemetrexed
Dosage Form
Solution, Concentrate
Route
Intravenous
Marketing
NDA
Active Listing

Vifor (International) Inc.

NDC Product
Human Prescription Drug

Mircera
NDC 59353-400

Generic Name
Methoxy Polyethylene Glycol-epoetin Beta
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Mircera
NDC 59353-401

Generic Name
Methoxy Polyethylene Glycol-epoetin Beta
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Mircera
NDC 59353-402

Generic Name
Methoxy Polyethylene Glycol-epoetin Beta
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Mircera
NDC 59353-403

Generic Name
Methoxy Polyethylene Glycol-epoetin Beta
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Mircera
NDC 59353-404

Generic Name
Methoxy Polyethylene Glycol-epoetin Beta
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Mircera
NDC 59353-405

Generic Name
Methoxy Polyethylene Glycol-epoetin Beta
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Mircera
NDC 59353-406

Generic Name
Methoxy Polyethylene Glycol-epoetin Beta
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Mircera
NDC 59353-407

Generic Name
Methoxy Polyethylene Glycol-epoetin Beta
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Mircera
NDC 59353-408

Generic Name
Methoxy Polyethylene Glycol-epoetin Beta
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
BLA
Active Listing

Wilshire Pharmaceuticals, Inc.

NDC Product
Human Prescription Drug

Dexmedetomidine Hydrochloride
NDC 52536-125

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

Dexmedetomidine Hydrochloride
NDC 52536-126

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

argenx US

NDC Product
Human Prescription Drug

Vyvgart Hytrulo
NDC 73475-3102

Generic Name
Efgartigimod Alfa And Hyaluronidase (human Recombinant)
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing

External Clinical & Regulatory Resources

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