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
bb912318-2e22-4469-b0a2-774803ee1bb8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 15, 2022
Manufacturers
FDA
Hospira, Inc.
DUNS: 141588017
Products 2
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 Code0409-2051
Application NumberANDA074549
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ketamine Hydrochloride
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJuly 15, 2022
FDA Product Classification
INGREDIENTS (3)
Ketamine HydrochlorideActive
Quantity: 100 mg in 1 mL
Code: O18YUO0I83
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZETHONIUM CHLORIDEInactive
Quantity: 0.10 mg in 1 mL
Code: PH41D05744
Classification: IACT
Ketamine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0409-2053
Application NumberANDA074549
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ketamine Hydrochloride
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJuly 15, 2022
FDA Product Classification
INGREDIENTS (3)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Ketamine HydrochlorideActive
Quantity: 50 mg in 1 mL
Code: O18YUO0I83
Classification: ACTIM
BENZETHONIUM CHLORIDEInactive
Quantity: 0.10 mg in 1 mL
Code: PH41D05744
Classification: IACT