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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71872-7258
Application NumberANDA074524
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ketamine Hydrochloride
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateApril 27, 2023
FDA Product Classification
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