Ketorolac Tromethamine
Ketorolac Tromethamine Tablets, USP 10mg
Approved
Approval ID
08674066-7d4b-936d-e063-6394a90abbd7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 1, 2024
Manufacturers
FDA
Northwind Pharmaceuticals, LLC
DUNS: 036986393
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 Code82868-020
Application NumberANDA215788
Product Classification
M
Marketing Category
C73584
G
Generic Name
ketorolac tromethamine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 1, 2024
FDA Product Classification
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
KETOROLAC TROMETHAMINEActive
Quantity: 10 mg in 1 1
Code: 4EVE5946BQ
Classification: ACTIB