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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68180-181
Application NumberANDA065396
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefadroxil
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68180-182
Application NumberANDA065396
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefadroxil
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2023
FDA Product Classification
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