Cefuroxime Axetil
CEFUROXIME AXETIL TABLETS, USP
Approved
Approval ID
16a686e6-63f4-478f-a673-02dde9474eda
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 22, 2010
Manufacturers
FDA
MedVantx, Inc.
DUNS: 806427725
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 Code66116-479
Application NumberANDA065359
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefuroxime Axetil
Product Specifications
Route of AdministrationORAL
Effective DateJune 23, 2010
FDA Product Classification
INGREDIENTS (11)
CEFUROXIME AXETILActive
Quantity: 500 mg in 1 1
Code: Z49QDT0J8Z
Classification: ACTIM
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT