Ketorolac Tromethamine
Ketorolac Tromethamine
Approved
Approval ID
095c834f-31b6-4313-8812-59e88a2764b6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 13, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-1328
Application NumberANDA074802
Marketing CategoryC73584
Route of AdministrationINTRAMUSCULAR
Effective DateJanuary 4, 2023
Generic NameKETOROLAC TROMETHAMINE
INGREDIENTS (6)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 8.7 mg in 2 mL
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
KETOROLAC TROMETHAMINEActive
Quantity: 60 mg in 2 mL
Code: 4EVE5946BQ
Classification: ACTIB
KETOROLAC TROMETHAMINE
PRODUCT DETAILS
NDC Product Code50090-1521
Application NumberANDA074802
Marketing CategoryC73584
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJanuary 4, 2023
Generic NameKETOROLAC TROMETHAMINE
INGREDIENTS (6)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
KETOROLAC TROMETHAMINEActive
Quantity: 30 mg in 1 mL
Code: 4EVE5946BQ
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 4.35 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT