CEFADROXIL
Cefadroxil Capsules, USP
Approved
Approval ID
8cf65b07-115e-4499-92c4-5f16792a954d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 11, 2010
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
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 Code16590-043
Application NumberANDA065352
Product Classification
M
Marketing Category
C73584
G
Generic Name
CEFADROXIL
Product Specifications
Route of AdministrationORAL
Effective DateAugust 11, 2010
FDA Product Classification
INGREDIENTS (10)
CEFADROXILActive
Quantity: 500 mg in 1 1
Code: 280111G160
Classification: ACTIB
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT