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

2.5 mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 69238-1347-3

Tadalafil Tablets USP, 5 mg

Rx Only

30 Tablets

Amneal Pharmaceuticals LLC

5 mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 69238-1348-3

Tadalafil Tablets USP, 10 mg

Rx Only

30 Tablets

Amneal Pharmaceuticals LLC

10 mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 69238-1349-3

Tadalafil Tablets USP, 20 mg

Rx Only

30 Tablets

Amneal Pharmaceuticals LLC

20 mg
(click image for full-size original)
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

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