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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-1328
Application NumberANDA074802
Product Classification
M
Marketing Category
C73584
G
Generic Name
KETOROLAC TROMETHAMINE
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateJanuary 4, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-1521
Application NumberANDA074802
Product Classification
M
Marketing Category
C73584
G
Generic Name
KETOROLAC TROMETHAMINE
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJanuary 4, 2023
FDA Product Classification
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