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Sildenafil 20 mg Tablet, Film Coated, 90-count — NDC 51407-0987-90 package photo
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Sildenafil 20 mg Tablet, Film Coated, 90-count — NDC 51407-987-90 (Billing 51407-0987-90)

by Golden State Medical Supply, Inc. · 90 TABLET, FILM COATED in 1 BOTTLE

This is a package of 90 tablets of Sildenafil 20 mg Tablet, Film Coated from Golden State Medical Supply, Inc., marketed since Mar 2025 and currently FDA-listed. It is this product's only package size.

NDC 51407-0987-90
🏷️ FDA NDC (as labeled) 51407-987-90 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 51407-987-90
Product NDC 51407-987
11-digit billing NDC 51407098790
NCPDP billing unit EA — each (per item)
RxCUI 577033
UNII BW9B0ZE037
Application # ANDA202954
SPL Set ID 512d1dbe-2d07-b3e0-e063-6394a90ae008
Established class (EPC) Phosphodiesterase 5 Inhibitor
Mechanism of action Phosphodiesterase 5 Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-03-06
Route ORAL
Dosage form TABLET, FILM COATED
Substance SILDENAFIL CITRATE
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 577033
Why two NDCs? The FDA registers this code as 51407-987-90 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 51407-0987-90. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Phosphodiesterase 5 Inhibitor class.

Pharmacologic class Phosphodiesterase 5 Inhibitor
Drug family (ATC) Drugs used in erectile dysfunction
How it works Phosphodiesterase 5 Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📖 What it is MedlinePlus · NLM

Sildenafil (Viagra) is used to treat erectile dysfunction (impotence; inability to get or keep an erection) in men. Sildenafil (Liqrev, Revatio) is used to improve the ability to exercise in adults (Liqrev, Revatio) and children 1 year of age and older (Revatio) with pulmonary arterial hypertension (PAH; high blood pressure in the vessels carrying blood to the lungs, causing shortness of breath, dizziness, and tiredness). Sildenafil is in a class of medications called phosphodiesterase (PDE) inhibitors. Sildenafil treats erectile dysfunction by increasing blood flow to the penis during sexual...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Viagra, Vybrique and some sildenafil tablets and oral films treat erectile dysfunction. Revatio and other sildenafil tablets, suspension and injection tr...
  • You take it as needed, usually about 1 hour before sex, though anywhere from 30 minutes to 4 hours works. Take it no more than once a day, with or without food. Oral film goes on y...
  • How do I take it for erectile dysfunction?
  • The common ones are headache, flushing, upset stomach, a stuffy nose and dizziness. Some people notice a color tinge or blur in their vision, which is usually mild and short-lived....
📖 Read our full Sildenafil guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.4421 $39.79 / 90 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
51407-0987-90 You're viewing this Main listing 90 TABLET, FILM COATED in 1 BOTTLE 2026-02-20 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sildenafil 20 mg 00904-6671-04 Major 30 tablets $0.051 AB Availability likely —
Sildenafil 20 mg 27241-0124-03 Ajanta 90 tablets $0.051 AB Availability likely —
Sildenafil 20 mg 31722-0776-05 Camber 500 tablets $0.051 AB Availability likely —
Sildenafil 20 mg 33342-0121-10 Macleods 90 tablets $0.051 AB Availability likely —
Sildenafil 20 mg 33342-0536-10 Macleods 90 tablets $0.051 AB Availability likely —
Sildenafil 20 mg 50268-0717-15 AvPAK 50 tablets $0.051 AB Availability likely —
Sildenafil 20 mg 60687-0788-21 American 1 tablet $0.051 AB Availability likely —
Sildenafil 20 mg 62135-0372-90 Chartwell 90 tablets $0.051 AB Availability likely —
Sildenafil 20 mg 65162-0351-09 Amneal 90 tablets $0.051 AB Availability likely —
Sildenafil 20 mg 65862-0688-90 Aurobindo 90 tablets $0.051 AB Availability likely —
Sildenafil 20 mg 68001-0363-05 BluePoint 90 tablets $0.051 AB Availability likely —
Sildenafil 20 mg 68001-0597-05 BluePoint 90 tablets $0.051 AB Availability likely —
Sildenafil Citrate 20 mg 72888-0018-00 Advagen 1000 tablets $0.051 AB Availability likely —
Sildenafil 20 mg 82009-0094-90 Quallent 90 tablets $0.051 AB Availability likely —
Sildenafil 20 mg 13668-0185-05 Torrent 500 tablets $0.077 AB FDA listed —
Sildenafil Citrate 20 mg 52817-0295-00 TruPharma 1000 tablets $0.077 AB FDA listed —
Sildenafil 20 mg 59762-0033-01 Mylan 90 tablets $0.077 AB Discontinued —
Revatio 20 mg 00069-4190-68 PFIZER 90 tablets — AB FDA listed —
Sildenafil 20 mg 42291-0937-90 AvKARE 90 tablets — AB FDA listed —
Sildenafil 20 mg 43063-0982-10 PD-Rx 10 tablets — AB FDA listed —
Sildenafil 20 mg 43353-0345-10 Aphena 10 tablets — AB Discontinued —
Sildenafil Citrate 20 mg 50090-3905-00 A-S 30 tablets — AB FDA listed —
Sildenafil 20 mg 50090-5236-00 A-S 30 tablets — AB FDA listed —
Sildenafil 20 mgthis 51407-0987-90 Golden 90 tablets — AB FDA listed —
Sildenafil 20 mg 51655-0172-20 Northwind 20 tablets — AB FDA listed —
Sildenafil Citrate 20 mg 51655-0793-20 Northwind 20 tablets — AB FDA listed —
Sildenafil 20 mg 53746-0351-90 Amneal 90 tablets — AB FDA listed —
Sildenafil 20 mg 55154-4307-00 Cardinal 10 tablets — AB FDA listed —
Revatio 20 mg 58151-0402-77 Viatris 90 tablets — AB FDA listed —
Sildenafil 20 mg 59746-0471-05 Jubilant 500 tablets — AB FDA listed —
Sildenafil 20 mg 63187-0619-10 Proficient 10 tablets — AB FDA listed —
Sildenafil 20 mg 63187-0789-10 Proficient 10 tablets — AB FDA listed —
Sildenafil 20 mg 63187-0813-10 Proficient 10 tablets — AB FDA listed —
Sildenafil 20 mg 63629-5029-00 Bryant 50 tablets — AB FDA listed —
Sildenafil 20 mg 68071-2072-01 NuCare 10 tablets — AB FDA listed —
Sildenafil 20 mg 68071-2213-09 NuCare 90 tablets — AB FDA listed —
Sildenafil 20 mg 68071-2537-09 NuCare 90 tablets — AB FDA listed —
Sildenafil 20 mg 68071-2602-03 NuCare 30 tablets — AB FDA listed —
Sildenafil 20 mg 68071-3954-09 NuCare 90 tablets — AB FDA listed —
Sildenafil 20 mg 68071-4517-09 NuCare 90 tablets — AB FDA listed —
Sildenafil 20 mg 68071-5115-06 NuCare 60 tablets — AB FDA listed —
Sildenafil 20 mg 68788-7974-03 Preferred 30 tablets — AB FDA listed —
Sildenafil 20 mg 70518-3433-00 REMEDYREPACK 30 tablets — AB Discontinued —
Sildenafil 20 mg 70518-4596-00 REMEDYREPACK 250 tablets — AB FDA listed —
Sildenafil Citrate 20 mg 71205-0305-10 Proficient 10 tablets — AB FDA listed —
Sildenafil 20 mg 71205-0509-30 Proficient 30 tablets — — FDA listed —
Sildenafil Citrate 20 mg 71205-0623-30 Proficient 30 tablets — AB FDA listed —
Sildenafil 20 mg 71335-1005-01 Bryant 10 tablets — AB FDA listed —
Sildenafil 20 mg 71335-1638-01 Bryant 10 tablets — AB FDA listed —
Sildenafil 20 mg 71335-1649-00 Bryant 50 tablets — AB FDA listed —
Sildenafil 20 mg 71335-1963-00 Bryant 50 tablets — AB FDA listed —
Sildenafil 20 mg 71335-2657-00 Bryant 50 tablets — AB FDA listed —
Sildenafil 20 mg 72162-2363-09 Bryant 90 tablets — AB FDA listed —
Sildenafil 20 mg 72189-0298-20 DirectRx 20 tablets — AB FDA listed —
Sildenafil 20 mg 72865-0105-90 XLCare 90 tablets — AB FDA listed —
Sildenafil 20 mg 76420-0061-30 Asclemed 30 tablets — AB FDA listed —
Sildenafil Citrate 20 mg 76420-0613-30 Asclemed 30 tablets — AB FDA listed —
Sildenafil Citrate 20 mg 80425-0304-01 Advanced 30 tablets — AB FDA listed —
Sildenafil 20 mg 82804-0185-30 Proficient 30 tablets — AB FDA listed —
Sildenafil 20 mg 82804-0243-30 Proficient 30 tablets — AB FDA listed —
Sildenafil Citrate 20 mg 82868-0094-30 Northwind 30 tablets — AB FDA listed —
Sildenafil 20 mg 50090-1766-00 A-S 30 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2025
On the market since
Mar 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color white
ShapeRound
ImprintC;D4
Size7 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII L11K75P92J
    A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII XHX3C3X673
    Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.

8 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerGolden State Medical Supply, Inc.
Application holderJUBILANT GENERICS LTD
FDA applicationANDA202954 (ANDA)
Labeler code51407
First marketedMar 2025
Product typeHuman Prescription Drug
Portfolio671 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 104 words ▾

1 INDICATIONS AND USAGE 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.

Adults Sildenafil tablets are 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 )

⏱️ Dosage and Administration 146 words ▾

2 DOSAGE AND ADMINISTRATION Adults: 20 mg three times a day. Dose may be increased based on symptoms and tolerability. ( 2.1 )

2.1Recommended Dosage in Adults Oral Dosage The recommended dosage of sildenafil tablets is 20 mg three times a day. Dose may be titrated to a maximum of 80 mg three times a day, if required, based on symptoms and tolerability [see Clinical Studies (14) ]. Although dose-response improvement in exercise ability was not observed in short-term studies in adults with PAH, the delay in clinical worsening with long-term use of sildenafil in Study A1481324 supports dosing up to a maximum of 80 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.

💊 Dosage Forms and Strengths 50 words ▾

3 DOSAGE FORMS AND STRENGTHS Sildenafil Tablets, USP Sildenafil tablets, USP 20 mg are supplied as white, round, biconvex, film coated tablets, debossed with ‘C’ on one side and ‘D4’ on the other side containing sildenafil citrate, USP equivalent to 20 mg of sildenafil. Tablets: 20 mg ( 3 )

⛔ Contraindications 107 words ▾

4 CONTRAINDICATIONS Sildenafil tablets are contraindicated in patients with: Concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension [see Warnings and Precautions (5.1) ]. Concomitant use of riociguat, a guanylate cyclase stimulator. Phosphodiesterase-5 (PDE-5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat.

Known hypersensitivity to sildenafil or any component of the tablet. Hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil. Use with organic nitrates or riociguat ( 4 ) History of hypersensitivity reaction to sildenafil or any component of the tablet ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Vasodilation effects may be more common in patients with hypotension or on antihypertensive therapy. ( 5.1 ) Use in pulmonary veno-occlusive disease (PVOD) may cause pulmonary edema and is not recommended. ( 5.2 ) Hearing or visual impairment: Seek medical attention if sudden decrease or loss of vision or hearing occurs.

( 5.4 , 5.5 ) Pulmonary hypertension (PH) secondary to sickle cell disease: Sildenafil may cause serious vaso-occlusive crises. ( 5.8 )

5.1Hypotension Sildenafil has vasodilatory properties, resulting in mild and transient decreases in blood pressure. Before prescribing sildenafil, carefully consider whether patients with certain underlying conditions could be adversely affected by such vasodilatory effects (e.g., patients on antihypertensive therapy or with resting hypotension [blood pressure less than 90/50], fluid depletion, severe left ventricular outflow obstruction, or autonomic dysfunction). Monitor blood pressure when co-administering blood pressure lowering drugs with sildenafil.

5.2Worsening Pulmonary Vascular Occlusive Disease Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD). Since there are no clinical data on administration of sildenafil to patients with veno-occlusive disease, administration of sildenafil to such patients is not recommended. Should signs of pulmonary edema occur when sildenafil is administered, consider the possibility of associated PVOD.

5.3Epistaxis The incidence of epistaxis was 13% in patients taking sildenafil with PAH secondary to CTD. This effect was not seen in idiopathic PAH (sildenafil 3%, placebo 2%) patients. The incidence of epistaxis was also higher in sildenafil-treated patients with a concomitant oral vitamin K antagonist (9% versus 2% in those not treated with concomitant vitamin K antagonist).

The safety of sildenafil is unknown in patients with bleeding disorders or active peptic ulceration.

5.4Visual Loss When used to treat erectile dysfunction, non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported postmarketing in temporal association with the use of PDE-5 inhibitors, including sildenafil. Most patients had underlying anatomic or vascular risk factors for developing NAION, including low cup to disc ratio (“crowded disc”). Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking sildenafil.

There are no controlled clinical data on the safety or efficacy of sildenafil in patients with retinitis pigmentosa, a minority of whom have genetic disorders of retinal phosphodiesterases. Therefore, use of sildenafil in patients with retinitis pigmentosa is not recommended.

5.5Hearing Loss Cases of sudden decrease or loss of hearing, which may be accompanied by tinnitus and dizziness, have been reported in temporal association with the use of PDE-5 inhibitors, including sildenafil. In some of the cases, medical conditions and other factors were reported that may have played a role. In many cases, medical follow-up information was limited.

It is not possible to determine whether these reported events are related directly to the use of sildenafil, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors. Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking PDE-5 inhibitors, including sildenafil.

5.6Combination with Other PDE-5 Inhibitors Sildenafil is also marketed as VIAGRA®. The safety and efficacy of combinations of sildenafil with VIAGRA or other PDE-5 inhibitors have not been studied. Inform patients taking sildenafil not to take VIAGRA or other PDE-5 inhibitors.

5.7Priapism Use sildenafil with caution in patients with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse events are discussed elsewhere in the labeling: Hypotension [see Warnings and Precautions (5.1) ] Vision Loss [see Warnings and Precautions (5.4) ] Hearing Loss [see Warnings and Precautions (5.5) ] Priapism [see Warnings and Precautions (5.7) ] Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Disease [see Warnings and Precautions (5.8) ] Adults: Headache, dyspepsia, flushing, pain in limb, myalgia, back pain and diarrhea. ( 6.1 , 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Jubilant Cadista Pharmaceuticals Inc. at 1-800-313-4623 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In a 12-week, placebo-controlled clinical study and an open-label extension study (SUPER-1) in 277 sildenafil-treated adults with PAH (WHO Group I) [see Clinical Studies (14) ] the adverse reactions that were reported by at least 10% of sildenafil-treated patients in any dosing group, and were more frequent in sildenafil-treated patients than in placebo-treated patients are shown in Table 1.

Adverse reactions were generally transient and mild to moderate in nature. The overall frequency of discontinuation in sildenafil-treated patients was 3% (20 mg and 40 mg three times a day) and 8% (80 mg three times a day). The overall frequency of discontinuation for placebo was 3%.

Table 1. Most Common Adverse Reactions in Patients Treated with Sildenafil 20 mg, 40 mg, 80 mg and Placebo Three Times Per Day in SUPER-1 (More Frequent in Sildenafil-Treated Patients than Placebo-Treated Patients) Sildenafil 20 mg (n = 69) Sildenafil 40 mg (n = 67) Sildenafil 80 mg (n = 71) Placebo (n = 70) Headache 46% 42% 49% 39% Flushing 10% 9% 16% 4% Pain in Limb 7% 15% 9% 6% Myalgia 7% 6% 14% 4% Back Pain 13% 13% 9% 11% Dyspepsia 13% 8% 13% 7% Diarrhea 9% 12% 10% 6% In a placebo-controlled fixed dose titration study (PACES-1) of sildenafil (starting with recommended dose of 20 mg and increased to 40 mg and then 80 mg all three times a day) as an adjunct to intravenous epoprostenol in patients with PAH, no new safety issues were identified except for edema, which occurred in 25% of subjects in the combined sildenafil + epoprostenol group compared with 13% of subjects in the epoprostenol group [see Clinical Studies (14) ] .

In a study to assess the effects of multiple doses of REVATIO on mortality in adults with PAH (StudyA1481324), the lower dose 5 mg TID group showed a higher observed number of deaths (all related to underlying disease/disease under study), serious adverse events, and severe adverse events than the 20 mg and 80 mg TID groups [see Clinical Studies (14) ] . Overall, the safety data for sildenafil 80 mg TID dose in Study A1481324 was consistent with the established safety profile of sildenafil in previous adult PAH studies.

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.

6.2Postmarketing Experience The following adverse reactions have been identified during post approval use of sildenafil (marketed for both PAH and erectile dysfunction). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiovascular Events In postmarketing experience with sildenafil at doses indicated for erectile dysfunction, serious cardiovascular, cerebrovascular, and vascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage,… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 154 words ▾

7 DRUG INTERACTIONS Nitrates Concomitant use of sildenafil with nitrates in any form is contraindicated [see Contraindications (4) ]. Strong CYP3A Inhibitors Concomitant use of sildenafil with strong CYP3A inhibitors is not recommended [see Clinical Pharmacology (12.3) ]. Moderate-to-Strong CYP3A Inducers Concomitant use of sildenafil with moderate-to-strong CYP3A inducers (such as bosentan) decreases the sildenafil exposure.

Dose up-titration of sildenafil may be needed when initiating treatment with moderate-to-strong CYP3A inducers. Reduce the dose of sildenafil to 20 mg three times a day when discontinuing treatment with moderate-to-strong CYP3A inducers [see Clinical Pharmacology (12.3) and Clinical Studies (14) ]. Use with strong CYP3A inhibitors: Not recommended.

( 7 , 12.3 ) Concomitant PDE-5 inhibitors: Avoid use with Viagra® or other PDE-5 inhibitors. ( 5.6 ) 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.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Limited published data from randomized controlled trials, case-controlled trials, and case series do not report a clear association with sildenafil and major birth defects, miscarriage, or adverse maternal or fetal outcomes when sildenafil is used during pregnancy. There are risks to the mother and fetus from untreated pulmonary arterial hypertension ( see Clinical Considerations ). Animal reproduction studies conducted with sildenafil showed no evidence of embryo-fetal toxicity or teratogenicity at doses up to 32- and 65-times the recommended human dose (RHD) of 20 mg three times a day in rats and rabbits, respectively ( see Data ).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Pregnant women with untreated pulmonary arterial hypertension are at risk for heart failure, stroke, preterm delivery, and maternal and fetal death. Data Animal Data No evidence of teratogenicity, embryotoxicity, or fetotoxicity was observed in pregnant rats or rabbits dosed with sildenafil 200 mg/kg/day during organogenesis, a level that is, on a mg/m2 basis, 32- and 65-times, respectively, the recommended human dose (RHD) of 20 mg three times a day.

In a rat pre- and postnatal development study, the no-observed-adverse-effect dose was 30 mg/kg/day (equivalent to 5-times the RHD on a mg/m 2 basis).

8.2Lactation Risk Summary Limited published data from a case report describe the presence of sildenafil and its active metabolite in human milk. There is insufficient information about the effects of sildenafil on the breastfed infant and no information on the effects of sildenafil on milk production. Limited clinical data during lactation preclude a clear determination of the risk of sildenafil to an infant during lactation.

8.4Pediatric Use The safety and effectiveness of sildenafil has not been established in pediatric patients younger than 1 year of age. 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.

8.5Geriatric Use Clinical studies of sildenafil did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see Clinical Pharmacology (12.3) ] .

8.6Patients with Hepatic Impairment No dose adjustment for mild to moderate impairment is required. Severe impairment has not been studied [see Clinical Pharmacology (12.3) ] .

8.7Patients with Renal Impairment No dose adjustment is required (including severe impairment CLcr < 30 mL/min) [see Clinical Pharmacology (12.3) ] .

🆘 Overdosage 66 words ▾

10 OVERDOSAGE In studies with healthy volunteers of single doses up to 800 mg, adverse events were similar to those seen at lower doses but rates and severities were increased. In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and it is not eliminated in the urine.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Sildenafil is an inhibitor of cGMP specific PDE-5 in the smooth muscle of the pulmonary vasculature, where PDE-5 is responsible for degradation of cGMP. Sildenafil, therefore, increases cGMP within pulmonary vascular smooth muscle cells resulting in relaxation. In patients with PAH, this can lead to vasodilation of the pulmonary vascular bed and, to a lesser degree, vasodilatation in the systemic circulation.

Studies in vitro have shown that sildenafil is selective for PDE5. Its effect is more potent on PDE5 than on other known phosphodiesterases (10-fold for PDE6, greater than 80-fold for PDE1, greater than 700-fold for PDE2, PDE3, PDE4, PDE7, PDE8, PDE9, PDE10, and PDE11). The approximately 4,000-fold selectivity for PDE-5 versus PDE3 is important because PDE3 is involved in control of cardiac contractility.

Sildenafil is only about 10 times as potent for PDE5 compared to PDE6, an enzyme found in the retina and involved in the phototransduction pathway of the retina. This lower selectivity is thought to be the basis for abnormalities related to color vision observed with higher doses or plasma levels [see Clinical Pharmacology (12.2) ]. In addition to pulmonary vascular smooth muscle and the corpus cavernosum, PDE5 is also found in other tissues including vascular and visceral smooth muscle and in platelets.

The inhibition of PDE5 in these tissues by sildenafil may be the basis for the enhanced platelet anti-aggregatory activity of nitric oxide observed in vitro , and the mild peripheral arterial-venous dilatation in vivo .

12.2Pharmacodynamics Effects of Sildenafil on Hemodynamic Measures Adults Patients on all sildenafil doses achieved a statistically significant reduction in mean pulmonary arterial pressure (mPAP) compared to those on placebo in a study with no background vasodilators [see SUPER-1 in Clinical Studies (14) ]. Data on other hemodynamic measures for the sildenafil 20 mg three times a day and placebo dosing regimens is displayed in Table 2. The relationship between these effects and improvements in 6-minute walk distance is unknown.

Table 2. Changes from Baseline in Hemodynamic Parameters at Week 12 [mean (95% CI)] for the Sildenafil 20 mg Three Times a Day and Placebo Group Placebo (n = 65)* Sildenafil 20 mg (n = 65)* mPAP (mmHg) 0.6 (-0.8, 2.0) -2.1 (-4.3, 0.0) PVR (dyn⋅s/cm 5 ) 49 (-54, 153) -122 (-217, -27) SVR (dyn⋅s/cm 5 ) -78 (-197, 41) -167 (-307, -26) RAP (mmHg) 0.3 (-0.9, 1.5) -0.8 (-1.9, 0.3) CO (L/min) -0.1 (-0.4, 0.2) 0.4 (0.1, 0.7) HR (beats/min) -1.3 (-4.1, 1.4) -3.7 (-5.9, -1.4) mPAP = mean pulmonary arterial pressure; PVR= pulmonary vascular resistance; SVR = systemic vascular resistance; RAP = right atrial pressure; CO = cardiac output; HR = heart rate ∗The number of patients per treatment group varied slightly for each parameter due to missing assessments.

Effects of Sildenafil on Blood Pressure Single oral doses of sildenafil 100 mg administered to healthy volunteers produced decreases in supine blood pressure (mean maximum decrease in systolic/diastolic blood pressure of 8/5 mmHg). The decrease in blood pressure was most notable approximately 1-2 hours after dosing and was not different from placebo at 8 hours. Similar effects on blood pressure were noted with 25 mg, 50 mg, and 100 mg doses of sildenafil, therefore the effects are not related to dose or plasma levels within this dosage range.

Larger effects were recorded among patients receiving concomitant nitrates [see Contraindications (4) ]. Single oral doses of sildenafil up to 100 mg in healthy volunteers produced no clinically relevant effects on electrocardiogram (ECG). After chronic dosing of 80 mg three times a day to patients with PAH, no clinically relevant effects on ECG were reported.

After chronic dosing of 80 mg three times a day sildenafil to healthy volunteers, the largest mean change from baseline in supine systolic and supine diastolic blood pressures was a decrease of… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 76 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil tablets, USP are supplied as white, round, biconvex, film coated tablets, debossed with ‘C’ on one side and ‘D4’ on the other side containing sildenafil citrate, USP equivalent to 20 mg of sildenafil. Bottles of 90 tablets with child-resistant closure NDC 51407-987-90 Recommended Storage for Sildenafil Tablets, USP: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

📋 Description 149 words ▾

11 DESCRIPTION Sildenafil, 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, USP is formulated as white, round, biconvex, film coated tablets, debossed with ‘C’ on one side and ‘D4’ on the other side equivalent to 20 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, USP each tablet contains the following inactive ingredients: anhydrous dibasic calcium phosphate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin. structure

💬 Information for Patients 147 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information) Inform patients of contraindication of sildenafil with regular and/or intermittent use of organic nitrates. Inform patients that sildenafil is also marketed as VIAGRA for erectile dysfunction. Advise patients taking sildenafil not to take VIAGRA or other PDE-5 inhibitors.

Advise patients to seek immediate medical attention for a sudden loss of vision in one or both eyes while taking sildenafil. Such an event may be a sign of NAION. Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking sildenafil.

These events may be accompanied by tinnitus and dizziness. All brand names listed are the registered trademarks of their respective owners and are not trademarks of Jubilant Generics Limited. Rx Only Made in USA Marketed by: GSMS, Inc.

Camarillo, CA 93012 USA Revised: 03/2026

🧪 Nonclinical Toxicology 187 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Sildenafil was not carcinogenic when administered to rats for up to 24 months at 60 mg/kg/day, a dose resulting in total systemic exposure (AUC) to unbound sildenafil and its major metabolite 33- and 37-times, for male and female rats, respectively, the human exposure at the RHD of 20 mg three times a day. Sildenafil was not carcinogenic when administered to male and female mice for up to 21 and 18 months, respectively, at doses up to a maximally tolerated level of 10 mg/kg/day, a dose equivalent to the RHD on a mg/m 2 basis.

Sildenafil was negative in in vitro bacterial and Chinese hamster ovary cell assays to detect mutagenicity, and in vitro human lymphocytes and in vivo mouse micronucleus assays to detect clastogenicity. There was no impairment of fertility in male or female rats given up to 60 mg sildenafil/kg/day, a dose producing a total systemic exposure (AUC) to unbound sildenafil and its major metabolite of 19- and 38-times for males and females, respectively, the human exposure at the RHD of 20 mg three times a day.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 184 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Sildenafil was not carcinogenic when administered to rats for up to 24 months at 60 mg/kg/day, a dose resulting in total systemic exposure (AUC) to unbound sildenafil and its major metabolite 33- and 37-times, for male and female rats, respectively, the human exposure at the RHD of 20 mg three times a day. Sildenafil was not carcinogenic when administered to male and female mice for up to 21 and 18 months, respectively, at doses up to a maximally tolerated level of 10 mg/kg/day, a dose equivalent to the RHD on a mg/m 2 basis.

Sildenafil was negative in in vitro bacterial and Chinese hamster ovary cell assays to detect mutagenicity, and in vitro human lymphocytes and in vivo mouse micronucleus assays to detect clastogenicity. There was no impairment of fertility in male or female rats given up to 60 mg sildenafil/kg/day, a dose producing a total systemic exposure (AUC) to unbound sildenafil and its major metabolite of 19- and 38-times for males and females, respectively, the human exposure at the RHD of 20 mg three times a day.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION SILDENAFIL TABLETS (sil den′ a fil) What is the most important information I should know about sildenafil tablets? Never take sildenafil tablets with any nitrate or guanylate cyclase stimulator medicines. • Your blood pressure could drop quickly to an unsafe level. Nitrates include: • Medicines that treat chest pain (angina) • Nitroglycerin in any form including tablets, patches, sprays, and ointments • Isosorbide mononitrate or dinitrate • Street drugs called “poppers” (amyl nitrate, butyl nitrate or nitrite) Guanylate cyclase stimulators include: • Riociguat, a medicine that treats pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension.

Ask your healthcare provider or pharmacist if you are not sure if you are taking a nitrate or a guanylate cyclase stimulator medicine. See “What are the possible side effects of Sildenafil tablets?” for more information about side effects. What are sildenafil tablets?

Sildenafil tablets are prescription medicine used to treat pulmonary arterial hypertension (PAH). PAH is a type of high blood pressure in the arteries of your lungs. Sildenafil tablets may be used in: • adults to improve your ability to exercise and help slow down the worsening of your physical condition.

It is not known if Sildenafil tablets are safe and effective in children younger than 1 year of age. Do not take sildenafil tablets if you: • take medicines called nitrates. • take riociguat, a guanylate cyclase stimulator medicine • are allergic to sildenafil or any of the ingredients in sildenafil tablets. See the end of this leaflet for a complete list of ingredients in sildenafil tablets Before taking sildenafil tablets, tell your healthcare provider about all of your medical conditions, including if you: • have low blood pressure • have heart problems • have pulmonary veno-occlusive disease (PVOD) • have bleeding problems or a stomach (peptic) ulcer.

It is not known if sildenafil tablets is safe in people with bleeding problems or who have a stomach ulcer. • have an eye problem called retinitis pigmentosa • have ever had sudden loss of vision in one or both eyes, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION) • have ever had hearing problems such as ringing in the ears, dizziness, or loss of hearing • have a deformed penis shape or Peyronie’s disease • have any blood cell problems such as sickle cell anemia • are pregnant or plan to become pregnant.

It is not known if sildenafil tablets will harm your unborn baby. • are breastfeeding or plan to breastfeed. Sildenafil passes into your breast milk. It is not known if it can harm your baby.

Talk with your healthcare provider about the best way to feed your baby during treatment with sildenafil tablets. Tell your healthcare provider about all of the medicines you take, including prescription and over- the-counter medicines, vitamins, and herbal supplements . Sildenafil tablets and certain other medicines may affect each other and can cause side effects.

Especially tell your healthcare provider if you take • nitrates or guanylate cyclase stimulators. See “What is the most important information I should know about sildenafil tablets? ” • medicines to treat high blood pressure • medicines for erectile dysfunction (impotence). sildenafil tablets contains sildenafil, which is the same medicine found in another medicine called VIAGRA®. VIAGRA is used for the treatment of erectile dysfunction.

Do not take VIAGRA or other PDE-5 inhibitors during treatment with sildenafil tablets. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure. Know the medicines you take.

Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. How should I take sildenafil tablets? • Take or give sildenafil tablets exactly as your healthcare provider tells you. • Your healthcare provider may change your dose of sildenafil tablets… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 29 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 20 mg Tablet, 90's Bottle Label NDC 51407-987-90 Sildenafil Tablets 20 mg 90 Tablets Rx Only 51407-987-90LB - Sildenafil Tablets 20g - rev 0326 .jpg

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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← 51407-0986-90 · Golden 51407-0989-60 · Golden →
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