SILDENAFIL (Page 9 of 9)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL

Sildenafil Tablets 25 mg — NDC 72888-015-30 — 30 Tablets Label

Sildenafil Tablets 25 mg -- NDC 72888-015-30 -- 30 Tablets Label
(click image for full-size original)

Sildenafil Tablets 25 mg — NDC 72888-015-05 — 500 Tablets Label

Sildenafil Tablets 25 mg -- NDC 72888-015-05 -- 500 Tablets Label
(click image for full-size original)

Sildenafil Tablets 50 mg — NDC 72888-016-30 — 30 Tablets Label

Sildenafil Tablets 50 mg -- NDC 72888-016-30 -- 30 Tablets Label
(click image for full-size original)

Sildenafil Tablets 50 mg — NDC 72888-016-01 — 100 Tablets Label

Sildenafil Tablets 50 mg -- NDC 72888-016-01 -- 100 Tablets Label
(click image for full-size original)

Sildenafil Tablets 50 mg — NDC 72888-016-00 — 1000 Tablets Label

Sildenafil Tablets 50 mg -- NDC 72888-016-00 -- 1000 Tablets Label
(click image for full-size original)

Sildenafil Tablets 100 mg — NDC 72888-017-30 — 30 Tablets Label

Sildenafil Tablets 100 mg -- NDC 72888-017-30 -- 30 Tablets Label
(click image for full-size original)

Sildenafil Tablets 100 mg — NDC 72888-017-01 — 100 Tablets Label

Sildenafil Tablets 100 mg -- NDC 72888-017-01 -- 100 Tablets Label
(click image for full-size original)

Sildenafil Tablets 100 mg — NDC 72888-017-00 — 1000 Tablets Label

Sildenafil Tablets 100 mg -- NDC 72888-017-00 -- 1000 Tablets Label
(click image for full-size original)
SILDENAFIL sildenafil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72888-015
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SILDENAFIL CITRATE (SILDENAFIL) SILDENAFIL 25 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE (15 MPA.S AT 5%)
SILICON DIOXIDE
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
TITANIUM DIOXIDE
TRIACETIN
FD&C BLUE NO. 2
Product Characteristics
Color blue Score no score
Shape OVAL (biconvex) Size 10mm
Flavor Imprint Code R;25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72888-015-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:72888-015-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204882 06/17/2021
SILDENAFIL sildenafil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72888-016
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SILDENAFIL CITRATE (SILDENAFIL) SILDENAFIL 50 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE (15 MPA.S AT 5%)
SILICON DIOXIDE
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
TITANIUM DIOXIDE
TRIACETIN
FD&C BLUE NO. 2
Product Characteristics
Color blue Score no score
Shape OVAL (biconvex) Size 13mm
Flavor Imprint Code R;50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72888-016-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:72888-016-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:72888-016-00 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204882 06/17/2021
SILDENAFIL sildenafil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72888-017
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
CROSPOVIDONE (15 MPA.S AT 5%)
SILICON DIOXIDE
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
TITANIUM DIOXIDE
TRIACETIN
FD&C BLUE NO. 2
Product Characteristics
Color blue Score no score
Shape OVAL (biconvex) Size 17mm
Flavor Imprint Code R;100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72888-017-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:72888-017-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:72888-017-00 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204882 06/17/2021
Labeler — Advagen Pharma Ltd (051627256)
Registrant — Rubicon Research Private Limited (918629544)
Establishment
Name Address ID/FEI Operations
Rubicon Research Private Limited 677604197 manufacture (72888-015), analysis (72888-015), pack (72888-015), manufacture (72888-016), analysis (72888-016), pack (72888-016), manufacture (72888-017), analysis (72888-017), pack (72888-017)

Revised: 11/2021 Advagen Pharma Ltd

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