Tadalafil (Page 12 of 12)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68180-919-06

Tadalafil Tablets USP

2.5 mg

Bottle of 30 tablets

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NDC 68180-920-06

Tadalafil Tablets USP

5 mg

Bottle of 30 tablets

image-11
(click image for full-size original)

NDC 68180-921-06

Tadalafil Tablets USP

10 mg

Bottle of 30 tablets

image-15
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NDC 68180-922-06

Tadalafil Tablets USP

20 mg

Bottle of 30 tablets

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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.

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