cefuroxime axetil
These highlights do not include all the information needed to use CEFUROXIME AXETIL TABLETS USP safely and effectively. See full prescribing information for CEFUROXIME AXETIL TABLETS USP. CEFUROXIME axetil tablets USP, for oral use Initial U.S. Approval: 1987
Approved
Approval ID
56a09adc-f383-4d17-a87e-8dac32cbfa51
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 6, 2016
Manufacturers
FDA
LUPIN LIMITED
DUNS: 675923163
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 Code57297-303
Application NumberANDA065135
Product Classification
M
Marketing Category
C73584
G
Generic Name
cefuroxime axetil
Product Specifications
Route of AdministrationORAL
Effective DateMay 6, 2016
FDA Product Classification
INGREDIENTS (11)
CEFUROXIME AXETILActive
Quantity: 500 mg in 1 1
Code: Z49QDT0J8Z
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT