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FDA Product

PROMETHAZINE HYDROCHLORIDE

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

Basic Information

PROMETHAZINE HYDROCHLORIDE

39822-5550

Regulatory Information

39822-5550

ANDA040737

C73584

January 9, 2024

USA

Promethazine Hydrochloride Injection, USP

HUMAN PRESCRIPTION DRUG LABEL

6

Company Information

117380305

Active Ingredients

CALCIUM CHLORIDE

Quantity: 0.01 mg in 1 mL

Code: M4I0D6VV5M

Class Code: IACT

SODIUM METABISULFITE

Quantity: 0.25 mg in 1 mL

Code: 4VON5FNS3C

Class Code: IACT

EDETATE SODIUM

Quantity: 0.1 mg in 1 mL

Code: MP1J8420LU

Class Code: IACT

PHENOL

Quantity: 5 mg in 1 mL

Code: 339NCG44TV

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

SODIUM ACETATE

Code: 4550K0SC9B

Class Code: IACT

ACETIC ACID

Code: Q40Q9N063P

Class Code: IACT

PROMETHAZINE HYDROCHLORIDE

Quantity: 50 mg in 1 mL

Code: R61ZEH7I1I

Class Code: ACTIB

Active Moieties

PROMETHAZINE

Code: FF28EJQ494

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