HISTIDINE HYDROCHLORIDE MONOHYDRATE
UNII X573657P6P

Substance Identification & Data

This profile provides standardized clinical and technical data for Histidine Hydrochloride Monohydrate, uniquely identified by the FDA Unique Ingredient Identifier (UNII) X573657P6P.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 5934-29-2 and the RxNorm Concept ID (RxCUI) 1305609. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.

FDA UNII Code
X573657P6P
CAS Registry Number
5934-29-2
RxNorm Concept ID
1305609

Detailed Substance Profile

Preferred Name
HISTIDINE HYDROCHLORIDE MONOHYDRATE
Official standardized name for this substance within the FDA UNII nomenclature system.
Molecular Formula
X573657P6P
The specific atomic composition represented as a molecular structure string.
InChIKey
C6H9N3O2.ClH.H2O
International Chemical Identifier digital signature for unique molecular identification.
SMILES String
CMXXUDSWGMGYLZ-XRIGFGBMSA-N
Line notation for describing the chemical structure and connectivity of atoms.
NCI Thesaurus
C87334
National Cancer Institute reference terminology for clinical and research data.
PubChem CID
165377
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(c1c[nH]cn1)[C@@H](C(=O)O)N.Cl.O

Synonyms and Nomenclature

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

Common Names & Synonyms

HISTIDINE HYDROCHLORIDE MONOHYDRATE [EP MONOGRAPH]
HISTIDINE, L-, MONOHYDROCHLORIDE MONOHYDRATE
L-HISTIDINE HYDROCHLORIDE HYDRATE [JAN]
L-HISTIDINE MONOHYDROCHLORIDE [FCC]
L-HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE [USP-RS]

Systematic Nomenclature

HISTIDINE HYDROCHLORIDE MONOHYDRATE
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE, (-)-
HISTIDINE, L-, HYDROCHLORIDE MONOHYDRATE
L-HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE
L-HISTIDINE, HYDROCHLORIDE, HYDRATE (1:1:1)

NDC Products Containing HISTIDINE HYDROCHLORIDE 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 (146), only Active Listings are currently displayed.
→ A-S Medication Solutions 4
→ Accord BioPharma Inc. 5
→ Amgen, Inc 1
→ AstraZeneca Pharmaceuticals LP 5
→ Biocon Biologics Inc. 4
→ CELLTRION USA, Inc. 3
→ CellTrans Inc. 1
→ Coherus BioSciences Inc 2
→ Cordavis Limited 3
→ Daiichi Sankyo Inc. 2
→ E.R. Squibb & Sons, L.L.C. 2
→ Eisai Inc. 2
→ Eli Lilly and Company 6
→ Fresenius Kabi USA, LLC 1
→ Genentech, Inc. 11
→ Genzyme Corporation 1
→ Golden State Medical Supply, Inc. 3
→ Hikma Pharmaceuticals USA Inc. 4
→ Horizon Therapeutics USA, Inc. 2
→ Invivyd, Inc 1
→ Janssen Biotech, Inc. 14
→ Lundbeck Pharmaceuticals LLC 1
→ Meitheal Pharmaceuticals Inc. 2
→ Merck Sharp & Dohme LLC 3
→ Merus US, Inc. 1
→ Novartis Pharmaceuticals Corporation 2
→ Nuvaila Limited 7
→ Organon LLC 10
→ Partner Therapeutics, Inc. 1
→ Pfizer Laboratories Div Pfizer Inc 5
→ Regeneron Pharmaceuticals, Inc 2
→ Regeneron Pharmaceuticals, Inc. 7
→ SEAGEN INC. 3
→ Sandoz Inc 3
→ Sanofi Vaccines US Inc. 2
→ Sanofi-Aventis U.S. LLC 2
→ Swedish Orphan Biovitrum AB (publ) 2
→ Teva Pharmaceuticals USA, Inc. 7
→ U.S. Pharmaceuticals 1

A-S Medication Solutions

NDC Product
Human Prescription Drug

Hadlima
NDC 50090-6705

Generic Name
Adalimumab-bwwd
Dosage Form
Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Hadlima
NDC 50090-6706

Generic Name
Adalimumab-bwwd
Dosage Form
Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Hadlima
NDC 50090-6707

Generic Name
Adalimumab-bwwd
Dosage Form
Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Selarsdi
NDC 50090-7769

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

Accord BioPharma Inc.

NDC Product
Human Prescription Drug

Hercessi
NDC 69448-015

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

Hercessi
NDC 69448-016

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

Imuldosa
NDC 69448-017

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

Imuldosa
NDC 69448-018

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

Imuldosa
NDC 69448-019

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

Amgen, Inc

NDC Product
Human Prescription Drug

Kanjinti
NDC 55513-132

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

AstraZeneca Pharmaceuticals LP

NDC Product
Human Prescription Drug

Saphnelo
NDC 0310-3040

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

Imfinzi
NDC 0310-4500

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

Imjudo
NDC 0310-4505

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

Imjudo
NDC 0310-4535

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

Imfinzi
NDC 0310-4611

Generic Name
Durvalumab
Dosage Form
Injection, Solution
Route
Intravenous
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 83257-024

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

Yesintek
NDC 83257-025

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

CELLTRION USA, Inc.

NDC Product
Human Prescription Drug

Steqeyma
NDC 72606-027

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

Steqeyma
NDC 72606-028

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

Steqeyma
NDC 72606-029

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

CellTrans Inc.

NDC Product
Cellular Therapy

Lantidra
NDC 73539-001

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

Coherus BioSciences Inc

NDC Product
Human Prescription Drug

Yusimry
NDC 70114-210

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

Yusimry
NDC 70114-220

Generic Name
Adalimumab-aqvh
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing

Cordavis Limited

NDC Product
Human Prescription Drug

Ospomyv
NDC 83457-012

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

Adalimumab-bwwd
NDC 83457-186

Generic Name
Adalimumab-bwwd
Dosage Form
Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Adalimumab-bwwd
NDC 83457-187

Generic Name
Adalimumab-bwwd
Dosage Form
Solution
Route
Subcutaneous
Marketing
BLA
Active Listing

Daiichi Sankyo Inc.

NDC Product
Human Prescription Drug

Enhertu
NDC 65597-406

Generic Name
Fam-trastuzumab Deruxtecan-nxki
Dosage Form
Injection, Powder, Lyophilized, For Solution
Route
Intravenous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Datroway
NDC 65597-801

Generic Name
Datopotamab Deruxtecan
Dosage Form
Injection, Powder, Lyophilized, For Solution
Route
Intravenous
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
NDC Product
Human Prescription Drug

Opdualag
NDC 0003-7125

Generic Name
Nivolumab And Relatlimab-rmbw
Dosage Form
Injection
Route
Intravenous
Marketing
BLA
Active Listing

Eisai Inc.

NDC Product
Human Prescription Drug

Leqembi
NDC 62856-212

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

Leqembi
NDC 62856-215

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

Eli Lilly and Company

NDC Product
Drug For Further Processing

NDC 0002-1436

Generic Name
Galcanezumab-gnlm
Dosage Form
Injection, Solution
Route
N/A
Marketing
DRUG FOR FURTHER PROCESSING
Active Listing
NDC Product
Human Prescription Drug

Emgality
NDC 0002-1436

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

Emgality
NDC 0002-2377

Generic Name
Galcanezumab-gnlm
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Drug For Further Processing

NDC 0002-2377

Generic Name
Galcanezumab-gnlm
Dosage Form
Injection, Solution
Route
N/A
Marketing
DRUG FOR FURTHER PROCESSING
Active Listing
NDC Product
Drug For Further Processing

NDC 0002-3115

Generic Name
Galcanezumab-gnlm
Dosage Form
Injection, Solution
Route
N/A
Marketing
DRUG FOR FURTHER PROCESSING
Active Listing
NDC Product
Human Prescription Drug

Emgality
NDC 0002-3115

Generic Name
Galcanezumab-gnlm
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing

Fresenius Kabi USA, LLC

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

Xolair
NDC 50242-040

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

Gazyva
NDC 50242-070

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

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

Herceptin
NDC 50242-132

Generic Name
Trastuzumab
Dosage Form
Injection, Powder, Lyophilized, For Solution
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

Xolair Pfs
NDC 50242-214

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

Xolair Pfs
NDC 50242-215

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

Genzyme Corporation

NDC Product
Human Prescription Drug

Nexviazyme
NDC 58468-0426

Generic Name
Avalglucosidase Alfa-ngpt
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 51407-929

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

Imuldosa
NDC 51407-930

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

Imuldosa
NDC 51407-931

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

Hikma Pharmaceuticals USA Inc.

NDC Product
Human Prescription Drug

Starjemza
NDC 0143-9168

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

Starjemza
NDC 0143-9169

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

Starjemza
NDC 0143-9170

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

Starjemza
NDC 0143-9171

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

Horizon Therapeutics USA, Inc.

NDC Product
Human Prescription Drug

Tepezza
NDC 75987-130

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

Uplizna
NDC 75987-150

Generic Name
Inebilizumab
Dosage Form
Injection
Route
Intravenous
Marketing
BLA
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

Stelara
NDC 57894-060

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

Stelara
NDC 57894-061

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

Simponi
NDC 57894-070

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

Simponi
NDC 57894-071

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

Simponi Aria
NDC 57894-350

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

Ustekinumab
NDC 57894-440

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

Ustekinumab
NDC 57894-441

Generic Name
Ustekinumab
Dosage Form
Injection, Solution
Route
Subcutaneous
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

Tremfya
NDC 57894-640

Generic Name
Guselkumab
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

Lundbeck Pharmaceuticals LLC

NDC Product
Human Prescription Drug

Vyepti
NDC 67386-130

Generic Name
Eptinezumab-jjmr
Dosage Form
Injection
Route
Intravenous
Marketing
BLA
Active Listing

Meitheal Pharmaceuticals Inc.

NDC Product
Human Prescription Drug

Yusimry
NDC 71288-815

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

Yusimry
NDC 71288-816

Generic Name
Adalimumab-aqvh
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
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

Enflonsia
NDC 0006-5073

Generic Name
Clesrovimab
Dosage Form
Injection, Solution
Route
Intramuscular
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

Merus US, Inc.

NDC Product
Human Prescription Drug

Bizengri
NDC 83077-100

Generic Name
Zenocutuzumab
Dosage Form
Injection
Route
Intravenous
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

Nuvaila Limited

NDC Product
Human Prescription Drug

Wezlana
NDC 84612-055

Generic Name
Ustekinumab-auub
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
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 84612-076

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

Wezlana
NDC 84612-089

Generic Name
Ustekinumab-auub
Dosage Form
Injection, Solution
Route
Subcutaneous
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

Ontruzant
NDC 78206-147

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

Ontruzant
NDC 78206-148

Generic Name
Ontruzant
Dosage Form
Kit
Route
Intravenous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Hadlima
NDC 78206-183

Generic Name
Adalimumab-bwwd
Dosage Form
Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Hadlima
NDC 78206-184

Generic Name
Adalimumab-bwwd
Dosage Form
Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Hadlima
NDC 78206-185

Generic Name
Adalimumab-bwwd
Dosage Form
Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Hadlima
NDC 78206-186

Generic Name
Adalimumab-bwwd
Dosage Form
Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Hadlima
NDC 78206-187

Generic Name
Adalimumab-bwwd
Dosage Form
Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Tofidence
NDC 78206-200

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

Tofidence
NDC 78206-201

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

Tofidence
NDC 78206-202

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

Partner Therapeutics, Inc.

NDC Product
Human Prescription Drug

Bizengri
NDC 71837-1000

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

Pfizer Laboratories Div Pfizer Inc

NDC Product
Human Prescription Drug

Ruxience
NDC 0069-0238

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

Ruxience
NDC 0069-0249

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

Trazimera
NDC 0069-0305

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

Elrexfio
NDC 0069-2522

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

Elrexfio
NDC 0069-4494

Generic Name
Elranatamab-bcmm
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing

Regeneron Pharmaceuticals, Inc

NDC Product
Human Prescription Drug

Eylea Hd
NDC 61755-050

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

Eylea Hd
NDC 61755-051

Generic Name
Aflibercept
Dosage Form
Injection, Solution
Route
Intravitreal
Marketing
BLA
Active Listing

Regeneron Pharmaceuticals, Inc.

NDC Product
Human Prescription Drug

Libtayo
NDC 61755-008

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

Evkeeza
NDC 61755-010

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

Evkeeza
NDC 61755-013

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

Veopoz
NDC 61755-014

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

Inmazeb
NDC 61755-018

Generic Name
Atoltivimab, Maftivimab, And Odesivimab-ebgn
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Lynozyfic
NDC 61755-054

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

Lynozyfic
NDC 61755-056

Generic Name
Linvoseltamab-gcpt
Dosage Form
Injection, Solution, Concentrate
Route
Intravenous
Marketing
BLA
Active Listing

SEAGEN INC.

NDC Product
Human Prescription Drug

Tivdak
NDC 51144-003

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

Padcev Ejfv
NDC 51144-020

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

Padcev Ejfv
NDC 51144-030

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

Sandoz Inc

NDC Product
Human Prescription Drug

Tyruko
NDC 61314-543

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

Cimerli
NDC 61314-624

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

Cimerli
NDC 61314-625

Generic Name
Ranibizumab-eqrn
Dosage Form
Injection, Solution
Route
Intravitreal
Marketing
BLA
Active Listing

Sanofi Vaccines US Inc.

NDC Product
Human Prescription Drug

Beyfortus
NDC 49281-574

Generic Name
Nirsevimab
Dosage Form
Injection
Route
Intramuscular
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Beyfortus
NDC 49281-575

Generic Name
Nirsevimab
Dosage Form
Injection
Route
Intramuscular
Marketing
BLA
Active Listing

Sanofi-Aventis U.S. LLC

NDC Product
Human Prescription Drug

Sarclisa
NDC 0024-0654

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

Sarclisa
NDC 0024-0656

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

Swedish Orphan Biovitrum AB (publ)

NDC Product
Human Prescription Drug

Gamifant
NDC 66658-501

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

Gamifant
NDC 66658-505

Generic Name
Emapalumab-lzsg
Dosage Form
Injection
Route
Intravenous
Marketing
BLA
Active Listing

Teva Pharmaceuticals USA, Inc.

NDC Product
Human Prescription Drug

Ustekinumab-aekn
NDC 51759-413

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

Ustekinumab-aekn
NDC 51759-414

Generic Name
Ustekinumab-aekn
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
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 51759-607

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
NDC Product
Human Prescription Drug

Ustekinumab-aekn
NDC 51759-709

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

Ustekinumab-aekn
NDC 51759-710

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

U.S. Pharmaceuticals

NDC Product
Human Prescription Drug

Elrexfio
NDC 63539-252

Generic Name
Elranatamab-bcmm
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing

External Clinical & Regulatory Resources

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