Finasteride (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL- CONTAINER PACK OF 90 TABLETS

NDC 71713-099-90

Finasteride Tablets, USP

1 mg

WARNING : Finasteride Tablets, USP should not be used by women or children. Women who are or may potentially be pregnant must not use Finasteride Tablets, USP. They should also not handle crushed or broken tablets of Finasteride Tablets, USP. (See Package Insert).

Rx Only

90 Tablets

Keeps

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FINASTERIDE finasteride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71713-099
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FINASTERIDE (FINASTERIDE) FINASTERIDE 1 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
LAUROYL PEG-32 GLYCERIDES
STARCH, CORN
Product Characteristics
Color BROWN (BROWN) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code F1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71713-099-90 90 TABLET in 1 CONTAINER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207750 03/22/2021
Labeler — Thirty Madison Inc (080774087)
Establishment
Name Address ID/FEI Operations
Alkem Laboratories Limited 677605851 MANUFACTURE (71713-099)

Revised: 04/2021 Thirty Madison Inc

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