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FDA Product

phenylephrine hydrochloride

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

Basic Information

phenylephrine hydrochloride

23155-620

Regulatory Information

23155-620

ANDA209968

C73584

March 2, 2023

USA

These highlights do not include all the information needed to use PHENYLEPHRINE HYDROCHLORIDE safely and effectively. See full prescribing information for PHENYLEPHRINE HYDROCHLORIDE. PHENYLEPHRINE HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval:2012

HUMAN PRESCRIPTION DRUG LABEL

4

Company Information

Active Ingredients

SODIUM CHLORIDE

Quantity: 3.5 mg in 1 mL

Code: 451W47IQ8X

Class Code: IACT

PHENYLEPHRINE HYDROCHLORIDE

Quantity: 10 mg in 1 mL

Code: 04JA59TNSJ

Class Code: ACTIB

CITRIC ACID MONOHYDRATE

Quantity: 1 mg in 1 mL

Code: 2968PHW8QP

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

TRISODIUM CITRATE DIHYDRATE

Quantity: 4 mg in 1 mL

Code: B22547B95K

Class Code: IACT

SODIUM METABISULFITE

Quantity: 2 mg in 1 mL

Code: 4VON5FNS3C

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

Active Moieties

PHENYLEPHRINE

Code: 1WS297W6MV

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