Cefuroxime Axetil

Basic Information

Product Name

Cefuroxime Axetil

FDA Product Code

68071-2958

Regulatory Information

NDC Product Code

68071-2958

Application Number

ANDA065308

Marketing Category

C73584

Effective Date

March 20, 2023

Territorial Authority

USA

FDA Title

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, for oral use Initial U.S. Approval: 1987

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

HYDROGENATED COTTONSEED OIL

Code: Z82Y2C65EA

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

POLYETHYLENE GLYCOL 400

Code: B697894SGQ

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

CEFUROXIME AXETIL

Quantity: 500 mg in 1 1

Code: Z49QDT0J8Z

Class Code: ACTIM

Active Moieties

CEFUROXIME

Code: O1R9FJ93ED

Basic Information

Regulatory Information

Company Information

Active Ingredients

HYDROGENATED COTTONSEED OIL

CROSCARMELLOSE SODIUM

SILICON DIOXIDE

HYPROMELLOSE, UNSPECIFIED

MICROCRYSTALLINE CELLULOSE

SODIUM LAURYL SULFATE

POLYETHYLENE GLYCOL 400

TITANIUM DIOXIDE

Active Moieties

CEFUROXIME