CEFUROXIME AXETIL
CEFUROXIME AXETIL
Approved
Approval ID
ad1a2f81-2595-47eb-9c2e-967c4b8e26bd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 3, 2015
Manufacturers
FDA
DIRECT RX
DUNS: 079254320
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 Code61919-145
Application NumberANDA065308
Product Classification
M
Marketing Category
C73584
G
Generic Name
CEFUROXIME AXETIL
Product Specifications
Route of AdministrationORAL
Effective DateNovember 3, 2015
FDA Product Classification
INGREDIENTS (9)
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
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CEFUROXIME AXETILActive
Quantity: 250 mg in 1 1
Code: Z49QDT0J8Z
Classification: ACTIM
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT