KETALAR
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use KETALAR® safely and effectively. See full prescribing information for KETALAR.KETALAR (ketamine hydrochloride) injection, for intravenous or intramuscular use, CIIIInitial U.S. Approval: 1970
Approved
Approval ID
9f675d38-d02f-455c-bc99-bac5924f5054
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 22, 2022
Manufacturers
FDA
General Injectables & Vaccines, Inc
DUNS: 108250663
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 Code52584-037
Application NumberNDA016812
Product Classification
M
Marketing Category
C73594
G
Generic Name
ketamine hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateDecember 22, 2022
FDA Product Classification
INGREDIENTS (3)
KETAMINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: O18YUO0I83
Classification: ACTIM
BENZETHONIUM CHLORIDEInactive
Code: PH41D05744
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT