Bicalutamide (Page 5 of 5)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 16714-816-01 in bottle of 30 tablets

Bicalutamide Tablets USP, 50 mg

R x only

30 tablets

Bicalutamide Tablets USP, 50 mg
(click image for full-size original)
BICALUTAMIDE bicalutamide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-816
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BICALUTAMIDE (BICALUTAMIDE) BICALUTAMIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (5 MPA.S)
POLYETHYLENE GLYCOL 400
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color white (WHITE TO OFF- WHITE) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code B50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-816-01 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:16714-816-02 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078917 06/01/2018
Labeler — Northstar RxLLC (830546433)
Establishment
Name Address ID/FEI Operations
Intas Pharmaceuticals Limited 725927649 analysis (16714-816), manufacture (16714-816)

Revised: 11/2019 Northstar RxLLC

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