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Sildenafil 20 mg Tablet, 50-count — NDC 50268-0717-15 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Sildenafil 20 mg Tablet, 50-count — NDC 50268-717-15 (Billing 50268-0717-15)

by AvPAK · 50 BLISTER PACK in 1 BOX, UNIT-DOSE / 1 TABLET in 1 BLISTER PACK

This is a package of 50 tablets of Sildenafil 20 mg Tablet from AvPAK, marketed since May 2015 and currently FDA-listed; retail pharmacies pay about $0.0511 per tablet (NADAC). It is this product's only package size.

NDC 50268-0717-15
🏷️ FDA NDC (as labeled) 50268-717-15 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 50268-717-15 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
50268 labeler · 717 product · 15 package
Package marketed since
May 29, 2015
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
50 EA per package
Barcode (UPC-A, from the NDC)
3 5026871715 9
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50268-717-15
Product NDC 50268-717
11-digit billing NDC 50268071715
NCPDP billing unit EA — each (per item)
RxCUI 577033
UNII BW9B0ZE037
Application # ANDA202025
SPL Set ID e08de794-9b7e-aae6-9c89-a0c0d090cc76
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 2015-05-29
Route ORAL
Dosage form TABLET
Substance SILDENAFIL CITRATE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 40143060100320
GPI class Sildenafil Citrate
GCN Seq No 059211
GCN 24758
HICL code 018084
Ingredient (HICL) Sildenafil Citrate
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B1
Therapeutic class — intermediate (HIC2) Affect Primarily Lungs
HIC3 code B1D
Therapeutic class — specific (HIC3) Pulm.anti-Htn,Sel.c-Gmp Phosphodiesterase T5 Inhib
AHFS code 24:08.12.00
AHFS class Phosphodiesterase Type 5 Inhibitors
FDB label name SILDENAFIL 20 MG TABLET
FDB brand name Sildenafil Citrate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 059211
  • GCN: 24758
  • GPI-14 (Medi-Span): 40143060100320
  • HICL (First Databank): 018084
  • AHFS class code: 24:08.12.00
  • RxCUI (RxNorm): 577033
Why two NDCs? The FDA registers this code as 50268-717-15 — 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 → 50268-0717-15. 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

Label name SILDENAFIL 20 MG TABLET Ingredient Sildenafil Citrate
📗 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 eaPer package
Retail pharmacies payNADAC · weekly $0.051 $2.56 / 50 tablet
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 $22.11 / 50 tablet
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.097 $0.051
▼ Down 45% over the last 24 months.
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
50268-0717-15 You're viewing this Main listing 50 BLISTER PACK in 1 BOX, UNIT-DOSE / 1 TABLET in 1 BLISTER PACK 2015-05-29 — 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 mgthis 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 +51%
Sildenafil Citrate 20 mg 52817-0295-00 TruPharma 1000 tablets $0.077 AB FDA listed +51%
Sildenafil 20 mg 59762-0033-01 Mylan 90 tablets $0.077 AB Discontinued +51%
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 mg 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

🏛️
2015
On the market since
May 2015
📍
2026
Currently FDA-listed
11 years 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.

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.

🧪 Avoiding an ingredient? See Sildenafil inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII 701EKV9RMN
    A mineral salt derived from calcium and phosphoric acid, used as a binder and filler in tablets and capsules to help hold ingredients together and add bulk to the formulation.
  • 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 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 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • 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.

9 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

LabelerAvPAK
Application holderAMNEAL PHARMACEUTICALS
FDA applicationANDA202025 (ANDA)
Labeler code50268
First marketedMay 2015
Product typeHuman Prescription Drug
Portfolio350 products on file

More NDCs from AvPAK labeler code 50268

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 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Patient Package Insert 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 144 words ▾

1 INDICATIONS AND USAGE Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when sildenafil tablets were added to background epoprostenol therapy [see Clinical Studies (14) ]. Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II-III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%).

Sildenafil tablets are a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in adults to improve exercise ability and delay clinical worsening. Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with NYHA Functional Class II-III symptoms. Etiologies were idiopathic (71%) or associated with connective tissue disease (25%).

(1)

⏱️ Dosage and Administration 69 words ▾

2 DOSAGE AND ADMINISTRATION Tablet: 20 mg three times a day, 4 to 6 hours apart (2.1)

2.1Sildenafil Tablets Oral Dosage The recommended dosage of sildenafil tablet is 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.

💊 Dosage Forms and Strengths 50 words ▾

3 DOSAGE FORMS AND STRENGTHS Sildenafil Tablets, USP Sildenafil Tablets USP, 20 mg are supplied as white to off-white, round shaped, film-coated tablets with debossing ‘AN 351’ on one side and plain on the other side, containing sildenafil citrate, USP equivalent to 20 mg of sildenafil. Tablets: 20 mg (3)

⛔ Contraindications 103 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 (5.2) ] . Concomitant use of riociguat, a guanylate cyclase stimulator. 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 Increased mortality with increasing doses in pediatric patients. Not recommended for use in pediatric patients. (5.1) Vasodilation effects may be more common in patients with hypotension or on antihypertensive therapy.

(5.2) Use in pulmonary veno-occlusive disease may cause pulmonary edema and is not recommended. (5.3) Hearing or visual impairment: Seek medical attention if sudden decrease or loss of vision or hearing occurs. (5.5 , 5.6) Pulmonary hypertension secondary to sickle cell disease: Sildenafil citrate may cause serious vaso-occlusive crises.

(5.9)

5.1Hypotension Sildenafil citrate has vasodilatory properties, resulting in mild and transient decreases in blood pressure. Before prescribing sildenafil citrate, 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 [BP 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 citrate.

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 citrate to patients with veno-occlusive disease, administration of sildenafil citrate to such patients is not recommended. Should signs of pulmonary edema occur when sildenafil citrate is administered, consider the possibility of associated PVOD.

5.3Epistaxis The incidence of epistaxis was 13% in patients taking sildenafil citrate with PAH secondary to CTD. This effect was not seen in idiopathic PAH (sildenafil citrate 3%, placebo 2%) patients. The incidence of epistaxis was also higher in sildenafil citrate-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 citrate 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 post-marketing 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 citrate.

There are no controlled clinical data on the safety or efficacy of sildenafil citrate in patients with retinitis pigmentosa, a minority of whom have genetic disorders of retinal phosphodiesterases. Therefore, use of sildenafil citrate 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 citrate. 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 citrate, 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 citrate.

5.6Combination with other PDE-5 Inhibitors Sildenafil is also marketed as VIAGRA ® . The safety and efficacy of combinations of sildenafil citrate with VIAGRA or other PDE-5 inhibitors ha… [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: Mortality with pediatric use [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4) ] Hypotension [see Warnings and Precautions (5.2) ] Vision loss [see Warnings and Precautions (5.5) ] Hearing loss [see Warnings and Precautions (5.6) ] Priapism [see Warnings and Precautions (5.8) ] Vaso-occlusive crisis [see Warnings and Precautions (5.9) ] Most common adverse reactions greater than or equal to 3% and more frequent than placebo were epistaxis, headache, dyspepsia, flushing, insomnia, erythema, dyspnea, and rhinitis.

(6.1 , 6.2) To report SUSPECTED ADVERSE REACTIONS, contact AvKARE, Inc. at 1-855-361-3993 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 citrate-treated adults with PAH (WHO Group I) [see Clinical Studies (14)] the adverse reactions that were reported by at least 10% of sildenafil citrate -treated patients in any dosing group, and were more frequent in sildenafil citrate -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 citrate-treated patients was 3% (20 mg and 40 mg three times a day). The overall frequency of discontinuation for placebo was 3%.

Table 1. Most Common Adverse Reactions in Patients with PAH in Study 1 (More Frequent in Sildenafil Citrate-Treated Patients than Placebo-Treated Patients and Incidence ≥3% in Sildenafil Citrate-Treated Patients) In a placebo-controlled fixed dose titration study (PACES-1) of sildenafil citrate (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 citrate + epoprostenol group compared with 13% of subjects in the epoprostenol group [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. 1

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, transient ischemic attack, hypertension, pulmonary hemorrhage, and subarachnoid and intracerebral hemorrhages have been reported in temporal association with the use of the drug.

Most, but not all, of these patients had preexisting cardiovascular risk factors. Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of sildenafil without sexual activity. Others were reported to have occurred hours to days after use concurrent with sexual activity.

It is not possible to determine whether these events are related directly to sildenafil, to sexual activity, to the patient’s underlying car… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 135 words ▾

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

Dose up-titration of sildenafil citrate 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)]. Concomitant alpha-blockers or amlodipine: Note additive blood pressure lowering effects.

(7) Use with ritonavir and other potent CYP3A inhibitors: Not recommended. (7 , 12.3) Concomitant PDE-5 inhibitors: Avoid use with Viagra or other PDE-5 inhibitors. (5.7)

👥 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% to 4% and 15% to 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 20mg 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/m2 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 citrate to an infant during lactation.

8.4Pediatric Use The safety and effectiveness of sildenafil citrate 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 citrate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. 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 phosphodiesterase type-5 (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 PDE-5. Its effect is more potent on PDE-5 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-fold as potent for PDE-5 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, PDE-5 is also found in other tissues including vascular and visceral smooth muscle and in platelets.

The inhibition of PDE-5 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 Citrate on Hemodynamic Measures Patients on all sildenafil citrate doses achieved a statistically significant reduction in mean pulmonary arterial pressure (mPAP) compared to those on placebo in a study with no background vasodilators [Study 1 in Clinical Studies (14)] . Data on other hemodynamic measures for the sildenafil citrate 20 mg three times a day and placebo dosing regimens is displayed in Table 3. The relationship between these effects and improvements in 6-minute walk distance is unknown.

Table 3. Changes from Baseline in Hemodynamic Parameters at Week 12 [mean (95% CI)] for the Sildenafil Citrate 20 mg Three Times a Day and Placebo Group Effects of Sildenafil Citrate 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 to 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 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 9 mmHg and 8.4 mmHg, respectively. After chronic dosing of 80 mg three times a day sildenafil to patients with systemic hypertension, the mean change from baseline in systolic and diastolic blood pressures was a decrease of 9.4 mmHg and 9.1 mmHg, respectively.

After chronic dosing of 80 mg three times a day sildenafil to patients with PAH, lesser reductions than above in systolic and diastolic blood pressures were observed (a decrease in both of 2 mmHg). Effects of Sildenafil Citrate on Vision At single oral doses of 100 mg and 200 mg, transient dose-related i… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 100 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil Tablets USP, 20 mg, are supplied as white to off-white, round shaped film-coated tablets with debossing ‘AN 351’ on one side and plain on the other side, containing sildenafil citrate, USP equivalent to the nominally indicated amount of sildenafil. They are available as follows: NDC 50268-717-15 (10 tablets per card, 5 cards per carton) Dispensed in Unit Dose package. For Institutional Use Only.

Recommended Storage for Sildenafil Tablets, USP: Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

📋 Description 143 words ▾

11 DESCRIPTION Sildenafil citrate, 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 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 are formulated as white to off-white, round shaped film-coated tablets for oral administration. Each tablet contains sildenafil citrate, USP equivalent to 20 mg of sildenafil. In addition to the active ingredient, sildenafil citrate USP, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.

1

💬 Information for Patients 136 words ▾

17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling ( Patient Information ). Inform patients of contraindication of sildenafil citrate 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 citrate 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 citrate. 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 citrate. These events may be accompanied by tinnitus and dizziness. All trademarks listed are the property of their respective owner.

Manufactured by: AvKARE Pulaski, TN 38478 Mfg. Rev. 04-2024-08 AV Rev.

03/25 (M)

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES Studies of Adults with Pulmonary Arterial Hypertension Study 1 (Sildenafil Citrate monotherapy (20 mg, 40 mg and 80 mg three times a day)) A randomized, double-blind, placebo-controlled study of sildenafil citrate (Study 1) was conducted in 277 patients with PAH (defined as a mean pulmonary artery pressure of greater than or equal to 25 mmHg at rest with a pulmonary capillary wedge pressure less than 15 mmHg). Patients were predominantly World Health Organization (WHO) functional classes II-III. Allowed background therapy included a combination of anticoagulants, digoxin, calcium channel blockers, diuretics, and oxygen.

The use of prostacyclin analogues, endothelin receptor antagonists, and arginine supplementation were not permitted. Subjects who had failed to respond to bosentan were also excluded. Patients with left ventricular ejection fraction less than 45% or left ventricular shortening fraction less than 0.2 also were not studied.

Patients were randomized to receive placebo (n=70) or sildenafil citrate 20 mg (n = 69), 40 mg (n = 67) or 80 mg (n = 71) three times a day for a period of 12 weeks. They had either primary pulmonary hypertension (PPH) (63%), PAH associated with CTD (30%), or PAH following surgical repair of left-to-right congenital heart lesions (7%). The study population consisted of 25% men and 75% women with a mean age of 49 years (range: 18 to 81 years) and baseline 6-minute walk distance between 100 and 450 meters (mean 343).

The primary efficacy endpoint was the change from baseline at week 12 (at least 4 hours after the last dose) in the 6-minute walk distance. Placebo-corrected mean increases in walk distance of 45 to 50 meters were observed with all doses of sildenafil citrate. These increases were significantly different from placebo, but the sildenafil citrate dose groups were not different from each other (see Figure 9), indicating no additional clinical benefit from doses higher than 20 mg three times a day.

The improvement in walk distance was apparent after 4 weeks of treatment and was maintained at week 8 and week 12. Figure 9. Change from Baseline in 6-Minute Walk Distance (meters) at Weeks 4, 8, and 12 in Study 1: Mean (95% Confidence Interval) Figure 10 displays subgroup efficacy analyses in Study 1 for the change from baseline in 6-Minute Walk Distance at Week 12 including baseline walk distance, disease etiology, functional class, gender, age, and hemodynamic parameters.

Figure 10. Placebo-Corrected Change From Baseline in 6-Minute Walk Distance (meters) at Week 12 by study subpopulation in Study 1: Mean (95% Confidence Interval) Key: PAH = pulmonary arterial hypertension; CTD = connective tissue disease; PH = pulmonary hypertension; PAP = pulmonary arterial pressure; PVRI = pulmonary vascular resistance index; TID = three times daily. Of the 277 treated patients, 259 entered a long-term, uncontrolled extension study.

At the end of 1 year, 94% of these patients were still alive. Additionally, walk distance and functional class status appeared to be stable in patients taking sildenafil citrate. Without a control group, these data must be interpreted cautiously.

Study 2 (Sildenafil Citrate co-administered with epoprostenol) A randomized, double-blind, placebo controlled study (Study 2) was conducted in 267 patients with PAH who were taking stable doses of intravenous epoprostenol. Patients had to have a mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg and a pulmonary capillary wedge pressure (PCWP) less than or equal to 15 mmHg at rest via right heart catheterization within 21 days before randomization, and a baseline 6-minute walk test distance greater than or equal to 100 meters and less than or equal to 450 meters (mean 349 meters).

Patients were randomized to placebo or sildenafil citrate (in a fixed titration starting from 20 mg, to 40 mg and then 80 mg, three times a day) and all patients continued intravenous epoprostenol therapy. At baseline… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 189 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.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION Sildenafil (sil-DEN-a-fil) Tablets, USP Read this Patient Information before you start taking sildenafil tablets and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment.

If you have any questions about sildenafil tablets, ask your doctor or pharmacist. 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. Nitrate medicines 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 or nitrite) Guanylate cyclase stimulators include: Riociguat (Adempas) Ask your doctor or pharmacist if you are not sure if you are taking a nitrate or a guanylate cyclase stimulator medicine. What are sildenafil tablets?

Sildenafil tablets are a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH). With PAH, the blood pressure in your lungs is too high. Your heart has to work hard to pump blood into your lungs.

Sildenafil tablets improves the ability to exercise and can slow down worsening changes in your physical condition. Sildenafil tablets are not for use in children Adding sildenafil tablets to another medication used to treat PAH, does not result in improvement in your ability to exercise. Sildenafil tablets contain the same medicine as VIAGRA ® (sildenafil), which is used to treat erectile dysfunction (impotence).

Do not take sildenafil tablets with VIAGRA or other PDE-5 inhibitors. Who should not take sildenafil tablets? Do not take sildenafil tablets if you: take nitrate medicines.

See “What is the most important information I should know about sildenafil tablets?” take guanylate cyclase stimulator medicines. See “What is the most important information I should know about sildenafil tablets?” are allergic to sildenafil or any other ingredient in sildenafil tablets. See “What are the ingredients in sildenafil tablets?” at the end of this leaflet.

What should I tell my doctor before taking sildenafil tablets? Tell your doctor about all of your medical conditions, including if you have heart problems such as angina (chest pain), heart failure, irregular heartbeats, or have had a heart attack have a disease called pulmonary veno-occlusive disease (PVOD) have high or low blood pressure or blood circulation problems have an eye problem called retinitis pigmentosa have or had loss of sight in one or both eyes have any problem with the shape of your penis or Peyronie’s disease have any blood cell problems such as sickle cell anemia have a stomach ulcer or any bleeding problems are pregnant or planning to become pregnant.

It is not known if sildenafil tablets could harm your unborn baby. are breastfeeding. It is not known if sildenafil citrate passes into your breast milk or if it could harm your baby. Tell your doctor about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal products.

Sildenafil tablets and certain other medicines can cause side effects if you take them together. The doses of some of your medicines may need to be adjusted while you take sildenafil tablets. Especially tell your doctor if you take Nitrate medicines.

See “What is the most important information I should know about sildenafil tablets?” Riociguat (Adempas). See “What is the most important information I should know about sildenafil tablets?” Ritonavir (Norvir ® ) or other medicines used to treat HIV infection Ketoconazole (Nizoral ® ) Itraconazole (Sporanox) High blood pressure medicine Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

How should I take silden… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 10 words ▾

RECENT MAJOR CHANGES Warnings and Precautions, Visual Loss (5.5) 07/2017

📄 Package Label / Principal Display Panel 5 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 1

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 50268-0711-15 · AvPAK 50268-0718-13 · AvPAK →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.