Tadalafil (Page 12 of 12)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68180-919-06

Tadalafil Tablets USP

2.5 mg

Bottle of 30 tablets

NDC 68180-920-06

Tadalafil Tablets USP

5 mg

Bottle of 30 tablets

NDC 68180-921-06

Tadalafil Tablets USP

10 mg

Bottle of 30 tablets

NDC 68180-922-06

Tadalafil Tablets USP

20 mg

Bottle of 30 tablets

TADALAFIL tadalafil tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-919 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 HYPROMELLOSES FERRIC OXIDE YELLOW FERRIC OXIDE RED LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE STARCH, CORN SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE TRIACETIN

Product Characteristics Color YELLOW (Light Yellow) Score no score Shape ROUND (biconvex) Size 6mm Flavor Imprint Code LU;T26 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68180-919-06 30 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210567 03/29/2019

TADALAFIL tadalafil tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-920 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 HYPROMELLOSES FERRIC OXIDE YELLOW LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE STARCH, CORN SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE TRIACETIN

Product Characteristics Color YELLOW Score no score Shape ROUND (biconvex) Size 6mm Flavor Imprint Code LU;T27 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68180-920-06 30 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210567 03/29/2019

TADALAFIL tadalafil tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-921 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 HYPROMELLOSES FERRIC OXIDE YELLOW LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE STARCH, CORN SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE TRIACETIN

Product Characteristics Color YELLOW Score no score Shape ROUND (biconvex) Size 8mm Flavor Imprint Code LU;T28 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68180-921-06 30 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210567 03/29/2019

TADALAFIL tadalafil tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-922 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 HYPROMELLOSES FERRIC OXIDE YELLOW LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE STARCH, CORN SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE TRIACETIN

Product Characteristics Color YELLOW Score no score Shape ROUND (biconvex) Size 11mm Flavor Imprint Code LU;T29 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68180-922-06 30 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210567 03/29/2019

Labeler — Lupin Pharmaceuticals, Inc. (089153071)

Registrant — LUPIN LIMITED (675923163)

Establishment
Name	Address	ID/FEI	Operations
LUPIN LIMITED		650759348	MANUFACTURE (68180-919), MANUFACTURE (68180-920), MANUFACTURE (68180-921), MANUFACTURE (68180-922), PACK (68180-919), PACK (68180-920), PACK (68180-921), PACK (68180-922)

Revised: 01/2022 Lupin Pharmaceuticals, Inc.