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 -- Label
(click image for full-size original)

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 2.5 mg -- Carton
(click image for full-size original)

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 -- Label
(click image for full-size original)

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 5 mg -- Carton
(click image for full-size original)

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 10 mg -- Label
(click image for full-size original)

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 Tablets, USP 20 mg -- Label
(click image for full-size original)
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.

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