CEFADROXIL
CEFADROXIL
Approved
Approval ID
a7e74b63-9d5c-7baa-e053-2a95a90a98b2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 27, 2023
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.
CEFADROXIL
PRODUCT DETAILS
NDC Product Code72189-103
Application NumberANDA065352
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 27, 2023
Generic NameCEFADROXIL
INGREDIENTS (10)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CEFADROXILActive
Quantity: 500 mg in 1 1
Code: 280111G160
Classification: ACTIM
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT