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
b96a0a23-3ca0-4a92-bd8b-1e9921931772
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 23, 2023
Manufacturers
FDA
Gland Pharma Limited
DUNS: 918601238
Products 3
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 Code68083-506
Application NumberANDA216809
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateFebruary 23, 2023
Generic NameKetamine Hydrochloride
INGREDIENTS (2)
BENZETHONIUM CHLORIDEInactive
Code: PH41D05744
Classification: IACT
KETAMINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 mL
Code: O18YUO0I83
Classification: ACTIM
Ketamine Hydrochloride
PRODUCT DETAILS
NDC Product Code68083-504
Application NumberANDA216809
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateFebruary 23, 2023
Generic NameKetamine Hydrochloride
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
Ketamine Hydrochloride
PRODUCT DETAILS
NDC Product Code68083-505
Application NumberANDA216809
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateFebruary 23, 2023
Generic NameKetamine Hydrochloride
INGREDIENTS (2)
KETAMINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 mL
Code: O18YUO0I83
Classification: ACTIM
BENZETHONIUM CHLORIDEInactive
Code: PH41D05744
Classification: IACT