Cefuroxime Axetil
These highlights do not include all the information needed to use cefuroxime axetil tablets safely and effectively. See full prescribing information for cefuroxime axetil tablets. CEFUROXIME AXETIL tablets, USP, for oral use Initial U.S. Approval: 1987
Approved
Approval ID
708b7a4d-ba1f-47b5-be4d-a01c2a7017ff
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 2, 2015
Manufacturers
FDA
Wockhardt Limited
DUNS: 650069115
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cefuroxime Axetil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55648-922
Application NumberANDA065166
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefuroxime Axetil
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 2, 2015
FDA Product Classification
INGREDIENTS (12)
CEFUROXIME AXETILActive
Quantity: 500 mg in 1 1
Code: Z49QDT0J8Z
Classification: ACTIM
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
DIBUTYL SEBACATEInactive
Code: 4W5IH7FLNY
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SMCCInactive
Code: B357P1G1IF
Classification: IACT