Ketorolac Tromethamine
Ketorolac Tromethamine Injection, USP FOR INTRAVENOUS/INTRAMUSCULAR USE (15 mg and 30 mg)
Approved
Approval ID
2301a6a2-b88a-4c0d-bb6c-ad4a8af7da39
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 14, 2023
Manufacturers
FDA
SOLA Pharmaceuticals, LLC
DUNS: 080121345
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 Code70512-843
Application NumberANDA217789
Marketing CategoryC73584
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateSeptember 14, 2023
Generic NameKetorolac Tromethamine
INGREDIENTS (7)
ANHYDROUS CITRIC ACIDInactive
Quantity: 1 mg in 1 mL
Code: XF417D3PSL
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Quantity: 100 mg in 1 mL
Code: 3K9958V90M
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 4.35 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
KETOROLAC TROMETHAMINEActive
Quantity: 30 mg in 1 mL
Code: 4EVE5946BQ
Classification: ACTIB
Ketorolac Tromethamine
PRODUCT DETAILS
NDC Product Code70512-842
Application NumberANDA217789
Marketing CategoryC73584
Route of AdministrationINTRAMUSCULAR
Effective DateSeptember 14, 2023
Generic NameKetorolac Tromethamine
INGREDIENTS (7)
ANHYDROUS CITRIC ACIDInactive
Quantity: 1 mg in 1 mL
Code: XF417D3PSL
Classification: IACT
ALCOHOLInactive
Quantity: 100 mg in 1 mL
Code: 3K9958V90M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 4.35 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
KETOROLAC TROMETHAMINEActive
Quantity: 15 mg in 1 mL
Code: 4EVE5946BQ
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT