Cefuroxime Axetil
Cefuroxime Axetil Tablets, USP
Approved
Approval ID
9ccf0781-4fb3-496e-bd58-54381ea33510
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 2011
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
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 Code52959-939
Application NumberANDA065308
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefuroxime Axetil
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2011
FDA Product Classification
INGREDIENTS (6)
CEFUROXIME AXETILActive
Quantity: 500 mg in 1 1
Code: Z49QDT0J8Z
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROGENATED COTTONSEED OILInactive
Code: Z82Y2C65EA
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT