NDC Code(s) : 50090-2453-1, 50090-2453-0
Packager : A-S Medication Solutions

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:50090-2453(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, UNSPECIFIED(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:50090-2453-190 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product06/12/2018
2NDC:50090-2453-030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product08/11/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090568 06/22/2010

LABELER - A-S Medication Solutions(830016429)

Establishment
Name Address ID/FEI Business Operations
A-S Medication Solutions 830016429 RELABEL(50090-2453)

PRINCIPAL DISPLAY PANEL

Label Image