MedPath
FDA Product

PHENERGAN

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

Basic Information

PHENERGAN

0641-6085

Regulatory Information

0641-6085

ANDA083312

C73584

April 19, 2022

USA

PHENERGAN Injection (promethazine hydrochloride Injection, USP)Rx only

HUMAN PRESCRIPTION DRUG LABEL

6

Company Information

946499746

Active Ingredients

EDETATE DISODIUM

Quantity: 0.1 mg in 1 mL

Code: 7FLD91C86K

Class Code: IACT

CALCIUM CHLORIDE

Quantity: 0.04 mg in 1 mL

Code: M4I0D6VV5M

Class Code: IACT

PROMETHAZINE HYDROCHLORIDE

Quantity: 50 mg in 1 mL

Code: R61ZEH7I1I

Class Code: ACTIB

SODIUM METABISULFITE

Quantity: 0.25 mg in 1 mL

Code: 4VON5FNS3C

Class Code: IACT

ACETIC ACID

Code: Q40Q9N063P

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

Active Moieties

PROMETHAZINE

Code: FF28EJQ494

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