Tadalafil (Page 12 of 12)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 2.5 mg

Tadalafil Tablets USP, 2.5 mg (30 Tablets in 1 Carton)
Each film-coated tablet contains 2.5 mg of Tadalafil USP. 62332-177-15

30 Tablets in 1 Carton
(click image for full-size original)

30 Tablets in 1 Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 5 mg

Tadalafil Tablets USP, 5 mg (30 Tablets in 1 Bottle)
Each film-coated tablet contains 5 mg of Tadalafil USP. 62332-178-30

30 Tablets in 1 Bottle
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 10 mg

Tadalafil Tablets USP, 10 mg (30 Tablets in 1 Bottle)
Each film-coated tablet contains 10 mg of Tadalafil USP. 62332-179-30

30 Tablets in 1 Bottle
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 20 mg

Tadalafil Tablets USP, 20 mg (30 Tablets in 1 Bottle)
Each film-coated tablet contains 20 mg of Tadalafil USP. 62332-180-30

30 Tablets in 1 Bottle
(click image for full-size original)
TADALAFIL tadalafil tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62332-177
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
HYDROXYPROPYL CELLULOSE (90000 WAMW)
LACTOSE MONOHYDRATE
CROSCARMELLOSE SODIUM
SODIUM LAURYL SULFATE
POVIDONE K25
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 6000
TALC
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW (YELLOW TO LIGHT YELLOW) Score no score
Shape ROUND Size 5mm
Flavor Imprint Code 336
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62332-177-15 30 TABLET, COATED in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204809 03/26/2019
TADALAFIL tadalafil tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62332-178
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
HYDROXYPROPYL CELLULOSE (90000 WAMW)
LACTOSE MONOHYDRATE
CROSCARMELLOSE SODIUM
SODIUM LAURYL SULFATE
POVIDONE K25
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 6000
TALC
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW (YELLOW TO LIGHT YELLOW) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 337
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62332-178-30 30 TABLET, COATED in 1 BOTTLE None
2 NDC:62332-178-15 30 TABLET, COATED in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204809 03/26/2019
TADALAFIL tadalafil tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62332-179
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
HYDROXYPROPYL CELLULOSE (90000 WAMW)
LACTOSE MONOHYDRATE
CROSCARMELLOSE SODIUM
SODIUM LAURYL SULFATE
POVIDONE K25
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 6000
TALC
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW (YELLOW TO LIGHT YELLOW) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 338
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62332-179-30 30 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204809 03/26/2019
TADALAFIL tadalafil tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62332-180
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
HYDROXYPROPYL CELLULOSE (90000 WAMW)
LACTOSE MONOHYDRATE
CROSCARMELLOSE SODIUM
SODIUM LAURYL SULFATE
POVIDONE K25
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 6000
TALC
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW (YELLOW TO LIGHT YELLOW) Score no score
Shape OVAL Size 14mm
Flavor Imprint Code L339
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62332-180-30 30 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204809 03/26/2019
Labeler — Alembic Pharmaceuticals Inc. (079288842)
Establishment
Name Address ID/FEI Operations
Alembic Pharmaceuticals Limited 650574671 MANUFACTURE (62332-177), MANUFACTURE (62332-178), MANUFACTURE (62332-179), MANUFACTURE (62332-180)

Revised: 03/2019 Alembic Pharmaceuticals Inc.

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