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
NDC Product Code63323-161
Application NumberANDA075784
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateNovember 18, 2022
Generic NameKETOROLAC TROMETHAMINE
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
NDC Product Code63323-162
Application NumberANDA075784
Marketing CategoryC73584
Route of AdministrationINTRAMUSCULAR
Effective DateNovember 18, 2022
Generic NameKETOROLAC TROMETHAMINE
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