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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70512-843
Application NumberANDA217789
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ketorolac Tromethamine
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateSeptember 14, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70512-842
Application NumberANDA217789
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ketorolac Tromethamine
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateSeptember 14, 2023
FDA Product Classification
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