Cefadroxil
CEFADROXIL CAPSULES USPCEFADROXIL TABLETS USP
Approved
Approval ID
b757af04-e516-4ac7-8a2f-45fffab86c5d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 26, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cefadroxil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-427
Application NumberANDA065311
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefadroxil
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 29, 2010
FDA Product Classification
INGREDIENTS (9)
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CEFADROXILActive
Quantity: 500 mg in 1 1
Code: 280111G160
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT