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Ketamine Hydrochloride

KetamineHydrochlorideInjection, USP

Approved
Approval ID

94e75168-b271-4f7e-96d5-716eb9c32dfa

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 23, 2012

Manufacturers
FDA

Physicians Total Care, Inc.

DUNS: 194123980

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 Code54868-4399
Application NumberANDA074549
Marketing CategoryC73584
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateApril 23, 2012
Generic NameKetamine Hydrochloride

INGREDIENTS (2)

KETAMINE HYDROCHLORIDEActive
Quantity: 50 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