NDC Code(s) : 0310-0600-60, 0310-0604-30
Packager : AstraZeneca Pharmaceuticals LP

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

NOLVADEXTamoxifen Citrate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0310-0600
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tamoxifen citrate(UNII: 7FRV7310N6)
(Tamoxifen - UNII:094ZI81Y45) 		Tamoxifen10 mg
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(UNII: K679OBS311)
magnesium stearate(UNII: 70097M6I30)
mannitol(UNII: 3OWL53L36A)
STARCH, POTATO(UNII: 8I089SAH3T)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code NOLVADEX;600
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0310-0600-6060 in 1 BOTTLE Type 0: Not a Combination Product01/09/1990
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017970 09/01/1990 03/31/2008
NOLVADEXTamoxifen Citrate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0310-0604
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tamoxifen citrate(UNII: 7FRV7310N6)
(Tamoxifen - UNII:094ZI81Y45) 		Tamoxifen20 mg
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(UNII: K679OBS311)
magnesium stearate(UNII: 70097M6I30)
mannitol(UNII: 3OWL53L36A)
STARCH, POTATO(UNII: 8I089SAH3T)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 10 mm
Flavor Imprint Code NOLVADEX;604
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0310-0604-3030 in 1 BOTTLE Type 0: Not a Combination Product01/12/1995
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017970 03/31/1994 03/31/2008

PRINCIPAL DISPLAY PANEL

Product Discontinued

PRINCIPAL DISPLAY PANEL

Product Discontinued