Tadalafil

Basic Information

Product Name

Tadalafil

FDA Product Code

31722-643

Regulatory Information

NDC Product Code

31722-643

Application Number

ANDA209908

Marketing Category

C73584

Effective Date

February 19, 2019

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral use Initial U.S. Approval: 2003

Labeling Type

Human Prescription Drug Label

Version Number

Active Ingredients

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

TADALAFIL

Quantity: 2.5 mg in 1 1

Code: 742SXX0ICT

Class Code: ACTIB

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

COPOVIDONE

Code: D9C330MD8B

Class Code: IACT

POLYOXYL 40 HYDROGENATED CASTOR OIL

Code: 7YC686GQ8F

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

TRIACETIN

Code: XHX3C3X673

Class Code: IACT

HYPROMELLOSE 2910 (15 MPA.S)

Code: 36SFW2JZ0W

Class Code: IACT

Active Moieties

Code: 742SXX0ICT

Tadalafil

Basic Information

Regulatory Information

Company Information

Active Ingredients

LACTOSE MONOHYDRATE

CROSCARMELLOSE SODIUM

SILICON DIOXIDE

COPOVIDONE

POLYOXYL 40 HYDROGENATED CASTOR OIL

MAGNESIUM STEARATE

TALC

MICROCRYSTALLINE CELLULOSE

TITANIUM DIOXIDE

FD&C BLUE NO. 2

TRIACETIN

HYPROMELLOSE 2910 (15 MPA.S)

Active Moieties

TADALAFIL