NDC Code(s) : 16729-035-10, 16729-035-15, 16729-035-16, 16729-035-17
Packager : Accord Healthcare Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AnastrozoleAnastrozole TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-035
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
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
POLYETHYLENE GLYCOL 300(UNII: 5655G9Y8AQ)
POVIDONE(UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color white Score no score
Shape ROUND (round biconvex) Size 6 mm
Flavor Imprint Code AHI
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:16729-035-1030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product22/06/2010
2NDC:16729-035-1590 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product24/02/2011
3NDC:16729-035-16500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product21/03/2011
4NDC:16729-035-171000 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product01/01/2026
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090568 06/22/2010

LABELER - Accord Healthcare Inc.(604222237)

Establishment
Name Address ID/FEI Business Operations
Intas Pharmaceuticals Limited 725927649 manufacture(16729-035), analysis(16729-035)

Establishment
Name Address ID/FEI Business Operations
Intas Pharmaceuticals Limited 915837971 manufacture(16729-035), analysis(16729-035)

PRINCIPAL DISPLAY PANEL

30 Tablets

bottle