Tadalafil (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 27241-123-02
60 Tablets
Tadalafil Tablets, USP
20 mg
Rx Onlyajanta

tadalafil-20mg
(click image for full-size original)
TADALAFIL tadalafil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:27241-123
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
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SODIUM LAURYL SULFATE
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 13mm
Flavor Imprint Code 20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:27241-123-02 60 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210392 02/06/2019
Labeler — Ajanta Pharma Limited (918594859)
Establishment
Name Address ID/FEI Operations
Ajanta Pharma Limited 918594859 MANUFACTURE (27241-123)

Revised: 12/2020 Ajanta Pharma Limited

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