Ketorolac Tromethamine
KETOROLAC TROMETHAMINE- ketorolac tromethamine tablet, film coated Burel Pharmaceuticals, LLC Rx only
Approved
Approval ID
76b52d47-8a89-4579-a361-053da6e676e8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 10, 2023
Manufacturers
FDA
Preferred Pharmaceuticals Inc.
DUNS: 791119022
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 Code68788-8504
Application NumberANDA210616
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ketorolac Tromethamine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 10, 2023
FDA Product Classification
INGREDIENTS (16)
KETOROLAC TROMETHAMINEActive
Quantity: 10 mg in 1 1
Code: 4EVE5946BQ
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT