Ketorolac tromethamine
Ketorolac Tromethamine Injection, USP Rx only FOR INTRAVENOUS/INTRAMUSCULAR USE (15 mg and 30 mg) FOR INTRAMUSCULAR USE ONLY (60 mg)
Approved
Approval ID
e17f583d-8bd4-3ed0-e053-2a95a90a9090
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 25, 2023
Manufacturers
FDA
Medical Purchasing Solutions, LLC
DUNS: 601458529
Products 1
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 Code71872-7288
Application NumberANDA204216
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ketorolac tromethamine
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateApril 25, 2023
FDA Product Classification
INGREDIENTS (5)
ALCOHOLInactive
Quantity: 100 mg in 2 mL
Code: 3K9958V90M
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
KETOROLAC TROMETHAMINEActive
Quantity: 60 mg in 2 mL
Code: 4EVE5946BQ
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 4.35 mg in 2 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT