NDC Code(s) : 29300-286-13, 29300-286-01, 29300-286-05, 29300-286-51, 29300-286-82, 29300-287-13, 29300-287-01, 29300-287-05, 29300-287-51, 29300-287-82, 29300-288-13, 29300-288-01, 29300-288-05, 29300-289-13, 29300-289-01, 29300-289-05
Packager : Unichem Pharmaceuticals (USA), Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

tadalafil tadalafil TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:29300-286
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TADALAFIL(UNII: 742SXX0ICT)
(TADALAFIL - UNII:742SXX0ICT) 		TADALAFIL2.5 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color ORANGE (Light Orange) Score no score
Shape OVAL Size 8 mm
Flavor Imprint Code U;286
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:29300-286-1330 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product26/03/2019
2NDC:29300-286-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product26/03/2019
3NDC:29300-286-05500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product26/03/2019
4NDC:29300-286-822 in 1 CARTON 26/03/2019
4NDC:29300-286-5115 in 1 BLISTER PACK Type 0: Not a Combination Product26/03/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209250 03/26/2019
tadalafil tadalafil TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:29300-287
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TADALAFIL(UNII: 742SXX0ICT)
(TADALAFIL - UNII:742SXX0ICT) 		TADALAFIL5 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color YELLOW Score no score
Shape OVAL (almond) Size 10 mm
Flavor Imprint Code U;287
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:29300-287-1330 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product26/03/2019
2NDC:29300-287-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product26/03/2019
3NDC:29300-287-05500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product26/03/2019
4NDC:29300-287-822 in 1 CARTON 26/03/2019
4NDC:29300-287-5115 in 1 BLISTER PACK Type 0: Not a Combination Product26/03/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209250 03/26/2019
tadalafil tadalafil TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:29300-288
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TADALAFIL(UNII: 742SXX0ICT)
(TADALAFIL - UNII:742SXX0ICT) 		TADALAFIL10 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color ORANGE (Light Orange) Score no score
Shape OVAL (almond) Size 10 mm
Flavor Imprint Code U;288
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:29300-288-1330 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product26/03/2019
2NDC:29300-288-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product26/03/2019
3NDC:29300-288-05500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product26/03/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209250 03/26/2019
tadalafil tadalafil TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:29300-289
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TADALAFIL(UNII: 742SXX0ICT)
(TADALAFIL - UNII:742SXX0ICT) 		TADALAFIL20 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color YELLOW Score no score
Shape OVAL (almond) Size 12 mm
Flavor Imprint Code U;289
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:29300-289-1330 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product26/03/2019
2NDC:29300-289-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product26/03/2019
3NDC:29300-289-05500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product26/03/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209250 03/26/2019

LABELER - Unichem Pharmaceuticals (USA), Inc.(181620514)

PRINCIPAL DISPLAY PANEL

Tadalafil Tablets USP 2.5 mg - CartonTadalafil Tablets USP 2.5 mg - CartonTadalafil Tablets USP 2.5 mg - CartonTadalafil Tablets USP 2.5 mg - CartonTadalafil Tablets USP 2.5 mg - CartonTadalafil Tablets USP 2.5 mg - Carton