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

NDC 70771-1048-3

Vardenafil Tablets, 5 mg

30 Tablets

Rx only

NDC 70771-1049-3

Vardenafil Tablets, 10 mg

30 Tablets

Rx only

NDC 70771-1050-3

Vardenafil Tablets, 20 mg

30 Tablets

Rx only

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