Drug Catalog - Product Detail
SILDENAFIL CITRATE 20MG TB 90CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 13668-0185-90 | TORRENT PHARMACEUTICALS | 90 | 20MG | TABLET |
PACKAGE FILES
Generic Name
SILDENAFIL CITRATE
Substance Name
SILDENAFIL CITRATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA091479
Description
11 DESCRIPTION Sildenafil tablets, USP, phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as VIAGRA ® for erectile dysfunction. Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H -pyrazolo [4,3- d ] pyrimidin-5-yl)-4- ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula: Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil Tablets USP: Sildenafil citrate is formulated as white, film-coated round tablets for oral administration. Each tablet contains sildenafil citrate equivalent to 20 mg of sildenafil. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, microcrystalline cellulose, sodium stearyl fumarate, titanium dioxide and triacetin. 1
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil 20 mg tablets USP are white to off-white, round biconvex film coated tablets debossed with '85' on one side and plain on other side. Bottles of 30 with child-resistant closure NDC 13668-185-30 Bottles of 90 with child-resistant closure NDC 13668-185-90 Bottles of 500 NDC 13668-185-05 Bottles of 5000 NDC 13668-185-51 Recommended Storage for Sildenafil Tablets USP: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
Indications & Usage
1 INDICATIONS AND USAGE Adults Sildenafil citrate is a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening. ( 1 ) Adults Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [ see Clinical Studies ( 14 ) ]. Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) tablets. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION • Adults: 20 mg three times a day. ( 2.1 ) 2.1 Recommended Dosage in Adults Oral Dosage The recommended dosage of sildenafil tablets are 20 mg three times a day. [see Clinical Studies ( 14 )] Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) tablets. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.