KETOROLAC TROMETHAMINE
KETOROLAC TROMETHAMINE- ketorolac tromethamine injection, solution
Approved
Approval ID
bdfb7f14-ad9c-4901-844b-aacfbb4429c3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 8, 2023
Manufacturers
FDA
NorthStar Rx LLC
DUNS: 830546433
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 Code72603-161
Application NumberANDA217789
Marketing CategoryC73584
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJuly 8, 2023
Generic Nameketorolac tromethamine
INGREDIENTS (6)
KETOROLAC TROMETHAMINEActive
Quantity: 30 mg in 1 mL
Code: 4EVE5946BQ
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 4.35 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
ketorolac tromethamine
PRODUCT DETAILS
NDC Product Code72603-153
Application NumberANDA217789
Marketing CategoryC73584
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJuly 8, 2023
Generic Nameketorolac tromethamine
INGREDIENTS (6)
KETOROLAC TROMETHAMINEActive
Quantity: 15 mg in 1 mL
Code: 4EVE5946BQ
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 6.68 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT