Ketorolac Tromethamine
FOR INTRAVENOUS/INTRAMUSCULAR USE (15 mg and 30 mg)FOR INTRAMUSCULAR USE ONLY (60 mg)Rx only
Approved
Approval ID
0c2c75c9-ed7b-46a8-9543-429bf2d8f090
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 12, 2023
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 946499746
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 Code0641-6042
Application NumberANDA075772
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ketorolac Tromethamine
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateMay 12, 2023
FDA Product Classification
INGREDIENTS (7)
KETOROLAC TROMETHAMINEActive
Quantity: 30 mg in 1 mL
Code: 4EVE5946BQ
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Quantity: 1 mg in 1 mL
Code: XF417D3PSL
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 4.35 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
ALCOHOLInactive
Quantity: 100 mg in 1 mL
Code: 3K9958V90M
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
Ketorolac Tromethamine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0641-6041
Application NumberANDA075772
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ketorolac Tromethamine
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateMay 12, 2023
FDA Product Classification
INGREDIENTS (7)
KETOROLAC TROMETHAMINEActive
Quantity: 15 mg in 1 mL
Code: 4EVE5946BQ
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 6.68 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Quantity: 1 mg in 1 mL
Code: XF417D3PSL
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
ALCOHOLInactive
Quantity: 100 mg in 1 mL
Code: 3K9958V90M
Classification: IACT
Ketorolac Tromethamine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0641-6043
Application NumberANDA075772
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ketorolac Tromethamine
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateMay 12, 2023
FDA Product Classification
INGREDIENTS (7)
KETOROLAC TROMETHAMINEActive
Quantity: 30 mg in 1 mL
Code: 4EVE5946BQ
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Quantity: 1 mg in 1 mL
Code: XF417D3PSL
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 4.35 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
ALCOHOLInactive
Quantity: 100 mg in 1 mL
Code: 3K9958V90M
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT