Cefuroxime axetil
Approved
Approval ID
1bc56a86-735c-4787-826a-9bb59027fa09
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 22, 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 Code52959-308
Application NumberANDA065496
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefuroxime axetil
Product Specifications
Route of AdministrationORAL
Effective DateDecember 22, 2011
FDA Product Classification
INGREDIENTS (13)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
Cefuroxime axetilActive
Quantity: 250 mg in 1 1
Code: Z49QDT0J8Z
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT