Bicalutamide

BICALUTAMIDE- bicalutamide tablet, film coated
Cadila Healthcare Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-613-06 in bottle of 30 tablets

Bicalutamide Tablets USP, 50 mg

Rx 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:65841-613
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
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (WHITE TO OFF- WHITE) Score no score
Shape ROUND (ROUND) Size 6mm
Flavor Imprint Code ZE;57
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-613-06 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65841-613-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65841-613-05 500 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65841-613-10 1000 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:65841-613-30 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
5 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65841-613-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079089 07/06/2009
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS (65841-613), MANUFACTURE (65841-613)

Revised: 08/2020 Cadila Healthcare Limited

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