Cefadroxil
Cefadroxil for Oral Suspension USP, 250 mg/5 mL and 500 mg/5 mL
Approved
Approval ID
27009a05-4d2b-4618-be76-39f348240eda
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2023
Manufacturers
FDA
Lupin Pharmaceuticals, Inc.
DUNS: 089153071
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cefadroxil
PRODUCT DETAILS
NDC Product Code68180-181
Application NumberANDA065396
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 31, 2023
Generic NameCefadroxil
INGREDIENTS (8)
CEFADROXILActive
Quantity: 250 mg in 5 mL
Code: 280111G160
Classification: ACTIM
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
PINEAPPLEInactive
Code: 2A88ZO081O
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
ORANGEInactive
Code: 5EVU04N5QU
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
Cefadroxil
PRODUCT DETAILS
NDC Product Code68180-182
Application NumberANDA065396
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 31, 2023
Generic NameCefadroxil
INGREDIENTS (8)
CEFADROXILActive
Quantity: 500 mg in 5 mL
Code: 280111G160
Classification: ACTIM
ORANGEInactive
Code: 5EVU04N5QU
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PINEAPPLEInactive
Code: 2A88ZO081O
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT