VARDENAFIL

VARDENAFIL- vardenafil hydrochloride trihydrate tablet, film coated
Cadila Healthcare Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1047-3

Vardenafil Tablets, 2.5 mg

30 Tablets

Rx only

Vardenafil Tablets
(click image for full-size original)

NDC 70771-1048-3

Vardenafil Tablets, 5 mg

30 Tablets

Rx only

Vardenafil Tablets
(click image for full-size original)

NDC 70771-1049-3

Vardenafil Tablets, 10 mg

30 Tablets

Rx only

Vardenafil Tablets
(click image for full-size original)

NDC 70771-1050-3

Vardenafil Tablets, 20 mg

30 Tablets

Rx only

Vardenafil Tablets
(click image for full-size original)
VARDENAFIL
vardenafil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1047
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VARDENAFIL HYDROCHLORIDE TRIHYDRATE (VARDENAFIL) VARDENAFIL 2.5 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
HYPROMELLOSES
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
SODIUM STEARYL FUMARATE
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape ROUND (ROUND) Size 5mm
Flavor Imprint Code 10;68
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1047-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1047-1 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1047-9 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208960 11/01/2018
VARDENAFIL
vardenafil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1048
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VARDENAFIL HYDROCHLORIDE TRIHYDRATE (VARDENAFIL) VARDENAFIL 5 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYPROMELLOSES
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
SODIUM STEARYL FUMARATE
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (LIGHT YELLOW) Score no score
Shape ROUND (ROUND) Size 5mm
Flavor Imprint Code 10;69
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1048-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1048-1 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1048-9 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208960 11/01/2018
VARDENAFIL
vardenafil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1049
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VARDENAFIL HYDROCHLORIDE TRIHYDRATE (VARDENAFIL) VARDENAFIL 10 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYPROMELLOSES
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
SODIUM STEARYL FUMARATE
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (LIGHT YELLOW TO ORANGE) Score no score
Shape ROUND (ROUND) Size 7mm
Flavor Imprint Code 10;70
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1049-9 90 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1049-3 30 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1049-1 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208960 11/01/2018
VARDENAFIL
vardenafil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1050
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VARDENAFIL HYDROCHLORIDE TRIHYDRATE (VARDENAFIL) VARDENAFIL 20 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYPROMELLOSES
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
SODIUM STEARYL FUMARATE
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (LIGHT YELLOW TO ORANGE) Score no score
Shape ROUND (ROUND) Size 8mm
Flavor Imprint Code 10;71
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1050-1 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1050-3 30 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1050-9 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208960 11/01/2018
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (863362789)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 863362789 ANALYSIS (70771-1047), ANALYSIS (70771-1048), ANALYSIS (70771-1049), ANALYSIS (70771-1050), MANUFACTURE (70771-1047), MANUFACTURE (70771-1048), MANUFACTURE (70771-1049), MANUFACTURE (70771-1050)

Revised: 09/2020 Cadila Healthcare Limited

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