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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4399
Application NumberANDA074549
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ketamine Hydrochloride
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateApril 23, 2012
FDA Product Classification
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