Sildenafil (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sildenafil 25mg 30s container label

XLcare25mg
(click image for full-size original)

Sildenafil 50mg 30s container label

XLcare50mg
(click image for full-size original)

Sildenafil 100mg 30s container label

XLcare100mg.jpg
(click image for full-size original)
SILDENAFIL sildenafil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72865-101
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
CROSCARMELLOSE SODIUM
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
TRIACETIN
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 7mm
Flavor Imprint Code E;113
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72865-101-30 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202659 08/01/2019
SILDENAFIL sildenafil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72865-102
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
CROSCARMELLOSE SODIUM
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
TRIACETIN
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 9mm
Flavor Imprint Code E;114
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72865-102-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:72865-102-01 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202659 08/01/2019
SILDENAFIL sildenafil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72865-103
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
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
TRIACETIN
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 12mm
Flavor Imprint Code E;115
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72865-103-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:72865-103-01 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202659 08/01/2019
Labeler — XLCARE Pharmaceuticals INC. (080991142)
Establishment
Name Address ID/FEI Operations
Evaric Pharmaceuticals Inc 080470330 ANALYSIS (72865-101), ANALYSIS (72865-102), ANALYSIS (72865-103), MANUFACTURE (72865-101), MANUFACTURE (72865-102), MANUFACTURE (72865-103)

Revised: 08/2019 XLCARE Pharmaceuticals INC.

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