Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Physicians Total Care, Inc.
Physicians Total Care, Inc.
194123980
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cefprozil
Product Details
NDC Product Code
54868-5757Application Number
ANDA065261Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 8, 2010SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CefprozilActive
Code: 4W0459ZA4VClass: ACTIBQuantity: 250 mg in 5 mL
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
ASPARTAMEInactive
Code: Z0H242BBR1Class: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
GLYCINEInactive
Code: TE7660XO1CClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311Class: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT