Ketorolac Tromethamine
Ketorolac Tromethamine Injection, USP
Approved
Approval ID
950b7295-3f68-4027-ac2b-2f7d0f5f8ef9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 18, 2022
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
KETOROLAC TROMETHAMINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-161
Application NumberANDA075784
Product Classification
M
Marketing Category
C73584
G
Generic Name
KETOROLAC TROMETHAMINE
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateNovember 18, 2022
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Quantity: 6.68 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
KETOROLAC TROMETHAMINEActive
Quantity: 15 mg in 1 mL
Code: 4EVE5946BQ
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Quantity: 1 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
KETOROLAC TROMETHAMINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-162
Application NumberANDA075784
Product Classification
M
Marketing Category
C73584
G
Generic Name
KETOROLAC TROMETHAMINE
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateNovember 18, 2022
FDA Product Classification
INGREDIENTS (5)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
KETOROLAC TROMETHAMINEActive
Quantity: 30 mg in 1 mL
Code: 4EVE5946BQ
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 4.35 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Quantity: 1 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT