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FDA Product

Ketamine Hydrochloride

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

Basic Information

Ketamine Hydrochloride

0409-2053

Regulatory Information

0409-2053

ANDA074549

C73584

July 15, 2022

USA

These highlights do not include all the information needed to use KETAMINE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for KETAMINE HYDROCHLORIDE INJECTION. KETAMINE HYDROCHLORIDE injection, for intravenous or intramuscular use, CIII Initial U.S. Approval: 1970

HUMAN PRESCRIPTION DRUG LABEL

16

Company Information

Hospira, Inc.

141588017

Active Ingredients

Ketamine Hydrochloride

Quantity: 50 mg in 1 mL

Code: O18YUO0I83

Class Code: ACTIM

Inactive Ingredients

WATER

Code: 059QF0KO0R

Class Code: IACT

BENZETHONIUM CHLORIDE

Quantity: 0.10 mg in 1 mL

Code: PH41D05744

Class Code: IACT

Active Moieties

KETAMINE

Code: 690G0D6V8H

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