Cefprozil
Approved
Approval ID
c6d3c1ff-d873-4903-befa-c0ba47034c6e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 8, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cefprozil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5757
Application NumberANDA065261
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefprozil
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2010
FDA Product Classification
INGREDIENTS (11)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CEFPROZILActive
Quantity: 250 mg in 5 mL
Code: 4W0459ZA4V
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GLYCINEInactive
Code: TE7660XO1C
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT