MedPath
FDA Product

Tadalafil

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Tadalafil

68180-920

Regulatory Information

68180-920

ANDA210567

C73584

June 26, 2023

USA

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 useInitial U.S. Approval: 2003

HUMAN PRESCRIPTION DRUG LABEL

12

Company Information

089153071

Active Ingredients

TADALAFIL

Quantity: 5 mg in 1 1

Code: 742SXX0ICT

Class Code: ACTIB

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

TRIACETIN

Code: XHX3C3X673

Class Code: IACT

Active Moieties

TADALAFIL

Code: 742SXX0ICT

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