Sildenafil Citrate

Basic Information

Product Name

Sildenafil Citrate

FDA Product Code

52817-295

Regulatory Information

NDC Product Code

52817-295

Application Number

ANDA204883

Marketing Category

C73584

Effective Date

June 22, 2020

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

SILICA DIMETHYL SILYLATE

Code: EU2PSP0G0W

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

TRIACETIN

Code: XHX3C3X673

Class Code: IACT

CROSPOVIDONE

Code: 68401960MK

Class Code: IACT

SILDENAFIL CITRATE

Quantity: 20 mg in 1 1

Code: BW9B0ZE037

Class Code: ACTIM

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

Active Moieties

SILDENAFIL

Code: 3M7OB98Y7H

Basic Information

Regulatory Information

Company Information

Active Ingredients

SILICA DIMETHYL SILYLATE

MAGNESIUM STEARATE

HYPROMELLOSES

TITANIUM DIOXIDE

LACTOSE MONOHYDRATE

TRIACETIN

CROSPOVIDONE

CELLULOSE, MICROCRYSTALLINE

Active Moieties

SILDENAFIL