SILDENAFIL CITRATE (Page 10 of 10)

PACKAGE LABEL/PRINCIPAL DISPLAY PANEL — 100 mg

Sildenafil Tablets, USP

100 mg

Rx Only

IMAGE
(click image for full-size original)
SILDENAFIL CITRATE
sildenafil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43063-940(NDC:13668-188)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SILDENAFIL CITRATE (SILDENAFIL) SILDENAFIL 100 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
HYPROMELLOSE 2910 (6 MPA.S)
FD&C BLUE NO. 2
CELLULOSE, MICROCRYSTALLINE
SODIUM STEARYL FUMARATE
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color blue Score no score
Shape ROUND (Biconvex) Size 12mm
Flavor Imprint Code 88
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43063-940-10 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:43063-940-15 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091448 06/11/2018
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (43063-940)

Revised: 08/2020 PD-Rx Pharmaceuticals, Inc.

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