ketorolac tromethamine
Ketorolac Tromethamine Injection, USP FOR INTRAVENOUS/INTRAMUSCULAR USE (15 mg and 30 mg) FOR INTRAMUSCULAR USE ONLY (60 mg) Rx only
Approved
Approval ID
1aae6a4d-0909-4672-aa26-e3f2d8c4d413
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 19, 2023
Manufacturers
FDA
FOSUN PHARMA USA INC
DUNS: 080920998
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 Code72266-119
Application NumberANDA204216
Product Classification
M
Marketing Category
C73584
G
Generic Name
ketorolac tromethamine
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateJune 19, 2023
FDA Product Classification
INGREDIENTS (5)
ALCOHOLInactive
Quantity: 100 mg in 1 mL
Code: 3K9958V90M
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 4.35 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
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 Code72266-118
Application NumberANDA204216
Product Classification
M
Marketing Category
C73584
G
Generic Name
ketorolac tromethamine
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJune 19, 2023
FDA Product Classification
INGREDIENTS (5)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
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
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 Code72266-234
Application NumberANDA204216
Product Classification
M
Marketing Category
C73584
G
Generic Name
ketorolac tromethamine
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJune 19, 2023
FDA Product Classification
INGREDIENTS (5)
ALCOHOLInactive
Quantity: 100 mg in 1 mL
Code: 3K9958V90M
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 6.68 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
KETOROLAC TROMETHAMINEActive
Quantity: 15 mg in 1 mL
Code: 4EVE5946BQ
Classification: ACTIB