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Ketamine Hydrochloride

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

Approved
Approval ID

c8e90cec-621e-f8d8-e053-2a95a90a49d4

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 27, 2023

Manufacturers
FDA

Medical Purchasing Solutions, LLC

DUNS: 601458529

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Ketamine Hydrochloride

PRODUCT DETAILS

NDC Product Code71872-7258
Application NumberANDA074524
Marketing CategoryC73584
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateApril 27, 2023
Generic NameKetamine Hydrochloride

INGREDIENTS (2)

KETAMINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 mL
Code: O18YUO0I83
Classification: ACTIM
BENZETHONIUM CHLORIDEInactive
Quantity: 0.1 mg in 1 mL
Code: PH41D05744
Classification: IACT

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Ketamine Hydrochloride - FDA Drug Approval Details