Tadalafil (Page 13 of 13)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Tadalafil Tablets, USP 2.5 mg — Label

NDC 16729- 369 -10

Tadalafil Tablets, USP

2.5 mg

Rx Only

Tablets should not be split. Entire dose should be taken.

30 Tablets

Tadalafil Tablets, USP 2.5 mg — Carton

NDC 16729- 369 -97

30 tablets (2 Blister Strips of 15 Tablets)

Tadalafil Tablets, USP

2.5 mg

For once daily use

Warning: Keep out of reach of children.

Tablets should not be split. Entire dose should be taken.

Rx Only

Tadalafil Tablets, USP 5 mg — Label

NDC 16729- 370 -10

Tadalafil Tablets, USP

5 mg

Rx Only

Tablets should not be split. Entire dose should be taken.

30 Tablets

Tadalafil Tablets, USP 5 mg — Carton

NDC 16729- 370 -97

30 tablets (2 Blister Strips of 15 Tablets)

Tadalafil Tablets, USP

5 mg

For once daily use

Warning: Keep out of reach of children.

Tablets should not be split. Entire dose should be taken.

Rx Only

Tadalafil Tablets, USP 10 mg — Label

NDC 16729- 371 -10

Tadalafil Tablets, USP

10 mg

Rx Only

Tablets should not be split. Entire dose should be taken.

30 Tablets

Tadalafil Tablets, USP 20 mg — Label

NDC 16729- 372 -10

Tadalafil Tablets, USP

20 mg

Rx Only

Tablets should not be split. Entire dose should be taken.

30 Tablets

TADALAFIL tadalafil tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-369 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 LACTOSE MONOHYDRATE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM HYPROMELLOSE 2910 (6 MPA.S) HYPROMELLOSE 2910 (3 MPA.S) SORBITAN MONOSTEARATE MAGNESIUM STEARATE FERRIC OXIDE RED FERRIC OXIDE YELLOW TALC TITANIUM DIOXIDE TRIACETIN

Product Characteristics Color white (Off white to Pale yellow) Score no score Shape OVAL (almond) Size 9mm Flavor Imprint Code FJ1 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:16729-369-10 30 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:16729-369-15 90 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:16729-369-16 500 TABLET, FILM COATED in 1 BOTTLE None 4 NDC:16729-369-17 1000 TABLET, FILM COATED in 1 BOTTLE None 5 NDC:16729-369-97 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK 5 15 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (16729-369-97)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209167 03/27/2019

TADALAFIL tadalafil tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-370 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 LACTOSE MONOHYDRATE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM HYPROMELLOSE 2910 (6 MPA.S) HYPROMELLOSE 2910 (3 MPA.S) SORBITAN MONOSTEARATE MAGNESIUM STEARATE FERRIC OXIDE YELLOW TALC TITANIUM DIOXIDE TRIACETIN

Product Characteristics Color yellow (light yellow) Score no score Shape OVAL (almond) Size 10mm Flavor Imprint Code FJ2 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:16729-370-10 30 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:16729-370-15 90 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:16729-370-16 500 TABLET, FILM COATED in 1 BOTTLE None 4 NDC:16729-370-17 1000 TABLET, FILM COATED in 1 BOTTLE None 5 NDC:16729-370-97 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK 5 15 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (16729-370-97)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209167 03/27/2019

TADALAFIL tadalafil tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-371 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 LACTOSE MONOHYDRATE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM HYPROMELLOSE 2910 (6 MPA.S) HYPROMELLOSE 2910 (3 MPA.S) SORBITAN MONOSTEARATE MAGNESIUM STEARATE FERRIC OXIDE YELLOW TALC TITANIUM DIOXIDE TRIACETIN

Product Characteristics Color yellow Score no score Shape OVAL (almond) Size 11mm Flavor Imprint Code FJ3 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:16729-371-10 30 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:16729-371-15 90 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:16729-371-16 500 TABLET, FILM COATED in 1 BOTTLE None 4 NDC:16729-371-17 1000 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209167 04/03/2020

TADALAFIL tadalafil tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-372 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 LACTOSE MONOHYDRATE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM HYPROMELLOSE 2910 (6 MPA.S) HYPROMELLOSE 2910 (3 MPA.S) SORBITAN MONOSTEARATE MAGNESIUM STEARATE FERRIC OXIDE YELLOW TALC TITANIUM DIOXIDE TRIACETIN

Product Characteristics Color yellow Score no score Shape OVAL (almond) Size 12mm Flavor Imprint Code FJ4 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:16729-372-10 30 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:16729-372-15 90 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:16729-372-16 500 TABLET, FILM COATED in 1 BOTTLE None 4 NDC:16729-372-17 1000 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209167 03/27/2019

Labeler — Accord Healthcare Inc. (604222237)

Establishment
Name	Address	ID/FEI	Operations
Intas Pharmaceuticals Limited		915837971	manufacture (16729-369), manufacture (16729-370), manufacture (16729-371), manufacture (16729-372), analysis (16729-369), analysis (16729-370), analysis (16729-371), analysis (16729-372)

Revised: 05/2020 Accord Healthcare Inc.