Sildenafil Citrate (Page 7 of 7)

PRINCIPAL DISPLAY PANEL — 20 mg Tablet Bottle Label

NDC 42543-005-90

Sildenafil Tablets, USP

20 mg

PHARMACIST: Please dispense with the patient information sheet.

Rx only

Vensun Pharmaceuticals, Inc.

90 Tablets

PRINCIPAL DISPLAY PANEL -- 20 mg Tablet Bottle Label
(click image for full-size original)

NDC 42543-005-10

Sildenafil Tablets, USP

20 mg

PHARMACIST: Please dispense with the patient

information sheet.

Rx only

Vensun Pharmaceuticals, Inc.

1000 Tablets

PRINCIPAL DISPLAY PANEL -- 20 mg Tablet Bottle Label
(click image for full-size original)
SILDENAFIL CITRATE sildenafil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42543-005
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
SILICA DIMETHYL SILYLATE
MAGNESIUM STEARATE
HYPROMELLOSES
LACTOSE MONOHYDRATE
TITANIUM DIOXIDE
TRIACETIN
CROSPOVIDONE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 7mm
Flavor Imprint Code R;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42543-005-90 90 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:42543-005-10 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204883 08/01/2016
Labeler — Vensun Pharmaceuticals, Inc. (078310501)
Registrant — Rubicon Research Private Limited (918629544)
Establishment
Name Address ID/FEI Operations
Rubicon Research Private Limited 677604197 Manufacture (42543-005), Analysis (42543-005)

Revised: 04/2018 Vensun Pharmaceuticals, Inc.

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