Tadalafil (Page 13 of 13)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP
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TADALAFIL tadalafil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-5092(NDC:31722-646)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TADALAFIL (TADALAFIL) TADALAFIL 20 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
COPOVIDONE
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYOXYL 40 HYDROGENATED CASTOR OIL
MICROCRYSTALLINE CELLULOSE
TALC
TITANIUM DIOXIDE
TRIACETIN
HYPROMELLOSE 2910 (15 MPA.S)
Product Characteristics
Color white Score no score
Shape CAPSULE Size 12mm
Flavor Imprint Code T15;H
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68071-5092-2 12 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209908 03/26/2019
Labeler — NuCare Pharmaceuticals,Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals,Inc. 010632300 repack (68071-5092)

Revised: 02/2021 NuCare Pharmaceuticals,Inc.

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