NDC Code(s) : 60505-2532-3, 60505-2532-5, 60505-2532-1, 60505-2532-8, 60505-2533-3, 60505-2533-5, 60505-2533-1, 60505-2533-8
Packager : Apotex Corp

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CefprozilCefprozil TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-2532
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFPROZIL(UNII: 4W0459ZA4V)
(CEFPROZIL ANHYDROUS - UNII:1M698F4H4E) 		CEFPROZIL ANHYDROUS250 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
Hydroxypropyl Cellulose (Type H)(UNII: RFW2ET671P)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
HYPROMELLOSE 2208 (15000 MPA.S)(UNII: Z78RG6M2N2)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHYLCELLULOSE (1500 MPA.S)(UNII: P0NTE48364)
POLYETHYLENE GLYCOL 8000(UNII: Q662QK8M3B)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
Product Characteristics
Color ORANGE (Light Orange) Score no score
Shape OVAL Size 3 mm
Flavor Imprint Code APO;CPZ;250
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60505-2532-330 in 1 BOTTLE Type 0: Not a Combination Product09/05/2008
2NDC:60505-2532-550 in 1 BOTTLE Type 0: Not a Combination Product09/05/2008
3NDC:60505-2532-1100 in 1 BOTTLE Type 0: Not a Combination Product09/05/2008
4NDC:60505-2532-81000 in 1 BOTTLE Type 0: Not a Combination Product09/05/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065327 05/09/2008
CefprozilCefprozil TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-2533
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFPROZIL(UNII: 4W0459ZA4V)
(CEFPROZIL ANHYDROUS - UNII:1M698F4H4E) 		CEFPROZIL ANHYDROUS500 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
Hydroxypropyl Cellulose (Type H)(UNII: RFW2ET671P)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
HYPROMELLOSE 2208 (15000 MPA.S)(UNII: Z78RG6M2N2)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHYLCELLULOSE (1500 MPA.S)(UNII: P0NTE48364)
POLYETHYLENE GLYCOL 8000(UNII: Q662QK8M3B)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 4 mm
Flavor Imprint Code APO;CPZ;500
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60505-2533-330 in 1 BOTTLE Type 0: Not a Combination Product09/05/2008
2NDC:60505-2533-550 in 1 BOTTLE Type 0: Not a Combination Product09/05/2008
3NDC:60505-2533-1100 in 1 BOTTLE Type 0: Not a Combination Product09/05/2008
4NDC:60505-2533-81000 in 1 BOTTLE Type 0: Not a Combination Product09/05/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065327 05/09/2008

PRINCIPAL DISPLAY PANEL

Representative sample of labeling (see HOW SUPPLIED section of complete listing):

APOTEX CORP. NDC 60505-2532-1

Cefprozil Tablets USP

250 mg

Rx Only

100 tablets count

PRINCIPAL DISPLAY PANEL

Representative sample of labeling (see HOW SUPPLIED section of complete listing):

APOTEX CORP. NDC 60505-2533-1

Cefprozil Tablets  USP 

500 mg

Rx Only

100 Tablets Count