Cefuroxime Axetil
Approved
Approval ID
61d3f51b-a8ed-4be5-849c-4bf653538d3e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 9, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
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 Code54868-5022
Application NumberANDA065308
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefuroxime Axetil
Product Specifications
Route of AdministrationORAL
Effective DateDecember 9, 2010
FDA Product Classification
INGREDIENTS (5)
CEFUROXIME AXETILActive
Quantity: 500 mg in 1 1
Code: Z49QDT0J8Z
Classification: ACTIB
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Cefuroxime Axetil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4987
Application NumberANDA065308
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefuroxime Axetil
Product Specifications
Route of AdministrationORAL
Effective DateDecember 9, 2010
FDA Product Classification
INGREDIENTS (5)
CEFUROXIME AXETILActive
Quantity: 250 mg in 1 1
Code: Z49QDT0J8Z
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT