Tadalafil (Page 12 of 12)

PRINCIPAL DISPLAY PANEL

NDC 69238-1346-3

Tadalafil Tablets USP, 2.5 mg

Rx Only

30 Tablets

Amneal Pharmaceuticals LLC

PRINCIPAL DISPLAY PANEL

NDC 69238-1347-3

Tadalafil Tablets USP, 5 mg

Rx Only

30 Tablets

Amneal Pharmaceuticals LLC

PRINCIPAL DISPLAY PANEL

NDC 69238-1348-3

Tadalafil Tablets USP, 10 mg

Rx Only

30 Tablets

Amneal Pharmaceuticals LLC

PRINCIPAL DISPLAY PANEL

NDC 69238-1349-3

Tadalafil Tablets USP, 20 mg

Rx Only

30 Tablets

Amneal Pharmaceuticals LLC

TADALAFIL tadalafil tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1346 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TADALAFIL (TADALAFIL) TADALAFIL 2.5 mg

Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE TRIACETIN

Product Characteristics Color white Score no score Shape ROUND Size 4mm Flavor Imprint Code C1 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69238-1346-3 30 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209744 03/27/2019

TADALAFIL tadalafil tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1347 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TADALAFIL (TADALAFIL) TADALAFIL 5 mg

Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED FERRIC OXIDE YELLOW LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE TRIACETIN

Product Characteristics Color yellow Score no score Shape ROUND Size 6mm Flavor Imprint Code A13 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69238-1347-3 30 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209744 03/27/2019

TADALAFIL tadalafil tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1348 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TADALAFIL (TADALAFIL) TADALAFIL 10 mg

Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED FERRIC OXIDE RED FERRIC OXIDE YELLOW LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE TRIACETIN

Product Characteristics Color yellow Score no score Shape ROUND Size 8mm Flavor Imprint Code AC;06 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69238-1348-3 30 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209744 03/27/2019

TADALAFIL tadalafil tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1349 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TADALAFIL (TADALAFIL) TADALAFIL 20 mg

Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED FERRIC OXIDE YELLOW LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE TRIACETIN

Product Characteristics Color yellow Score no score Shape OVAL Size 13mm Flavor Imprint Code AA;09 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69238-1349-3 30 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209744 03/27/2019

Labeler — Amneal Pharmaceuticals NY LLC (123797875)

Revised: 03/2020 Amneal Pharmaceuticals NY LLC