MedPath
FDA Product

Naloxone Hydrochloride

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Naloxone Hydrochloride

71872-7219

Regulatory Information

71872-7219

ANDA212455

C73584

April 26, 2023

USA

Naloxone Hydrochloride Injection, USP Rx only

HUMAN PRESCRIPTION DRUG LABEL

2

Company Information

601458529

Active Ingredients

NALOXONE HYDROCHLORIDE

Quantity: 0.4 mg in 1 mL

Code: F850569PQR

Class Code: ACTIB

WATER

Code: 059QF0KO0R

Class Code: IACT

SODIUM CHLORIDE

Quantity: 9 mg in 1 mL

Code: 451W47IQ8X

Class Code: IACT

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

Active Moieties

NALOXONE

Code: 36B82AMQ7N

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