NDC Code(s) : 70954-433-10, 70954-434-10, 70954-435-10
Packager : ANI Pharmaceuticals, Inc.

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Tadalafil Tadalafil TABLET
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:70954-433
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
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MANNITOL(UNII: 3OWL53L36A)
FRUCTOSE(UNII: 6YSS42VSEV)
CROSPOVIDONE(UNII: 68401960MK)
SUCRALOSE(UNII: 96K6UQ3ZD4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FD&C BLUE NO. 1 ALUMINUM LAKE(UNII: J9EQA3S2JM)
ACACIA(UNII: 5C5403N26O)
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code 433;N
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70954-433-1030 in 1 BOTTLE Type 0: Not a Combination Product03/06/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215949 03/06/2023
Tadalafil Tadalafil TABLET
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:70954-434
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
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MANNITOL(UNII: 3OWL53L36A)
FRUCTOSE(UNII: 6YSS42VSEV)
CROSPOVIDONE(UNII: 68401960MK)
SUCRALOSE(UNII: 96K6UQ3ZD4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FD&C BLUE NO. 1 ALUMINUM LAKE(UNII: J9EQA3S2JM)
ACACIA(UNII: 5C5403N26O)
Product Characteristics
Color BLUE Score no score
Shape OVAL (Modified oval) Size 11 mm
Flavor Imprint Code 434;N
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70954-434-1030 in 1 BOTTLE Type 0: Not a Combination Product03/06/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215949 03/06/2023
Tadalafil Tadalafil TABLET
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:70954-435
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
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MANNITOL(UNII: 3OWL53L36A)
FRUCTOSE(UNII: 6YSS42VSEV)
CROSPOVIDONE(UNII: 68401960MK)
SUCRALOSE(UNII: 96K6UQ3ZD4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FD&C BLUE NO. 1 ALUMINUM LAKE(UNII: J9EQA3S2JM)
ACACIA(UNII: 5C5403N26O)
Product Characteristics
Color BLUE Score no score
Shape OVAL (Modified oval) Size 12 mm
Flavor Imprint Code 435;N
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70954-435-1030 in 1 BOTTLE Type 0: Not a Combination Product03/06/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215949 03/06/2023

LABELER - ANI Pharmaceuticals, Inc.(145588013)

Establishment
Name Address ID/FEI Business Operations
Novitium Pharma LLC 080301870 ANALYSIS(70954-433, 70954-434, 70954-435), LABEL(70954-433, 70954-434, 70954-435), MANUFACTURE(70954-433, 70954-434, 70954-435), PACK(70954-433, 70954-434, 70954-435)

PRINCIPAL DISPLAY PANEL

Tadalafil Tablets, USP 5 mg

Bottles of 30            NDC 70954-433-10
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Tadalafil Tablets, USP 10 mg
Bottles of 30   NDC 70954-434-10
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Tadalafil Tablets, USP 20 mg
Bottles of 30   NDC 70954-435-10
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