NDC 70954-435-10
API & Excipient Details

Tadalafil marketed by ANI Pharmaceuticals, Inc. under NDC Code 70954-435-10

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TADALAFIL(UNII: 742SXX0ICT) (TADALAFIL - UNII:742SXX0ICT)	TADALAFIL	5 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70954-433-10	30 in 1 BOTTLE Type 0: Not a Combination Product	03/06/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TADALAFIL(UNII: 742SXX0ICT) (TADALAFIL - UNII:742SXX0ICT)	TADALAFIL	10 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70954-434-10	30 in 1 BOTTLE Type 0: Not a Combination Product	03/06/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TADALAFIL(UNII: 742SXX0ICT) (TADALAFIL - UNII:742SXX0ICT)	TADALAFIL	20 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70954-435-10	30 in 1 BOTTLE Type 0: Not a Combination Product	03/06/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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