Tadalafil

Basic Information

Product Name

Tadalafil

FDA Product Code

68788-8153

Regulatory Information

NDC Product Code

68788-8153

Application Number

ANDA209167

Marketing Category

C73584

Effective Date

September 26, 2023

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

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

HYPROMELLOSE 2910 (6 MPA.S)

Code: 0WZ8WG20P6

Class Code: IACT

HYPROMELLOSE 2910 (3 MPA.S)

Code: 0VUT3PMY82

Class Code: IACT

SORBITAN MONOSTEARATE

Code: NVZ4I0H58X

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

TRIACETIN

Code: XHX3C3X673

Class Code: IACT

TADALAFIL

Quantity: 20 mg in 1 1

Code: 742SXX0ICT

Class Code: ACTIB

Active Moieties

Code: 742SXX0ICT

Tadalafil

Basic Information

Regulatory Information

Company Information

Active Ingredients

MICROCRYSTALLINE CELLULOSE

CROSCARMELLOSE SODIUM

LACTOSE MONOHYDRATE

HYPROMELLOSE 2910 (6 MPA.S)

HYPROMELLOSE 2910 (3 MPA.S)

SORBITAN MONOSTEARATE

MAGNESIUM STEARATE

FERRIC OXIDE YELLOW

TALC

TITANIUM DIOXIDE

TRIACETIN

Active Moieties

TADALAFIL