NDC Code(s) : 68382-209-06, 68382-209-10
Packager : Zydus Pharmaceuticals USA Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AnastrozoleAnastrozole TABLET, COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-209
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ANASTROZOLE(UNII: 2Z07MYW1AZ)
(ANASTROZOLE - UNII:2Z07MYW1AZ) 		ANASTROZOLE1 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE, UNSPECIFIED FORM(UNII: J2B2A4N98G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
POVIDONE(UNII: FZ989GH94E)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE (WHITE) Score no score
Shape ROUND (ROUND) Size 6 mm
Flavor Imprint Code A7
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68382-209-0630 in 1 BOTTLE Type 0: Not a Combination Product27/06/2010
2NDC:68382-209-101000 in 1 BOTTLE Type 0: Not a Combination Product27/06/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078921 06/27/2010

LABELER - Zydus Pharmaceuticals USA Inc.(156861945)

REGISTRANT - Zydus Pharmaceuticals USA Inc.(156861945)

Establishment
Name Address ID/FEI Business Operations
Zydus Lifesciences Limited 918596198 ANALYSIS(68382-209), MANUFACTURE(68382-209)

PRINCIPAL DISPLAY PANEL

NDC 68382-209-10 in bottle of 1000 tablets

Anastrozole Tablets, 1 mg

Rx only

1000 tablets

ZYDUS

Anastrozole Tablets, 1mg