SILDENAFIL CITRATE (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sildenafil Tablets 20 mg

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SILDENAFIL CITRATE sildenafil citrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-185
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SILDENAFIL CITRATE (SILDENAFIL) SILDENAFIL 20 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (6 MPA.S)
SODIUM STEARYL FUMARATE
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color white (White to off white) Score no score
Shape ROUND (Round) Size 7mm
Flavor Imprint Code 85
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-185-30 30 TABLET in 1 BOTTLE None
2 NDC:13668-185-90 90 TABLET in 1 BOTTLE None
3 NDC:13668-185-05 500 TABLET in 1 BOTTLE None
4 NDC:13668-185-51 5000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091479 11/06/2012
Labeler — Torrent Pharmaceuticals Limited (916488547)
Registrant — Torrent Pharma, Inc. (790033935)
Establishment
Name Address ID/FEI Operations
Torrent Pharmaceuticals Limited 916488547 manufacture (13668-185)

Revised: 03/2023 Torrent Pharmaceuticals Limited

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