Ketalar
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, CIII Initial U.S. Approval: 1970
Approved
Approval ID
14e8f864-8b8a-4e7e-8439-e510d3107063
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 23, 2023
Manufacturers
FDA
Par Pharmaceutical, Inc.
DUNS: 092733690
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42023-115
Application NumberNDA016812
Product Classification
M
Marketing Category
C73594
G
Generic Name
ketamine hydrochloride
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateDecember 18, 2023
FDA Product Classification
INGREDIENTS (2)
KETAMINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 mL
Code: O18YUO0I83
Classification: ACTIM
BENZETHONIUM CHLORIDEInactive
Code: PH41D05744
Classification: IACT
ketamine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42023-114
Application NumberNDA016812
Product Classification
M
Marketing Category
C73594
G
Generic Name
ketamine hydrochloride
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateDecember 18, 2023
FDA Product Classification
INGREDIENTS (2)
BENZETHONIUM CHLORIDEInactive
Code: PH41D05744
Classification: IACT
KETAMINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 mL
Code: O18YUO0I83
Classification: ACTIM
ketamine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42023-113
Application NumberNDA016812
Product Classification
M
Marketing Category
C73594
G
Generic Name
ketamine hydrochloride
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateDecember 18, 2023
FDA Product Classification
INGREDIENTS (3)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
KETAMINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: O18YUO0I83
Classification: ACTIM
BENZETHONIUM CHLORIDEInactive
Code: PH41D05744
Classification: IACT