KETOROLAC TROMETHAMINE
Injection, USP
Approved
Approval ID
342128cd-36f6-4a94-a004-b446e891e4f9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 5, 2023
Manufacturers
FDA
Steriscience Specialties Private Limited
DUNS: 853179150
Products 3
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 Code82449-220
Application NumberANDA201155
Product Classification
M
Marketing Category
C73584
G
Generic Name
KETOROLAC TROMETHAMINE
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateJuly 5, 2023
FDA Product Classification
INGREDIENTS (6)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
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 Code82449-218
Application NumberANDA201155
Product Classification
M
Marketing Category
C73584
G
Generic Name
KETOROLAC TROMETHAMINE
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJuly 5, 2023
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
KETOROLAC TROMETHAMINEActive
Quantity: 15 mg in 1 mL
Code: 4EVE5946BQ
Classification: ACTIB
KETOROLAC TROMETHAMINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82449-219
Application NumberANDA201155
Product Classification
M
Marketing Category
C73584
G
Generic Name
KETOROLAC TROMETHAMINE
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJuly 5, 2023
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
KETOROLAC TROMETHAMINEActive
Quantity: 30 mg in 1 mL
Code: 4EVE5946BQ
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT