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Revatio sildenafil citrate .8 mg/mL Injection, Solution, 1 vial — NDC 58151-0395-31 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Revatio sildenafil citrate .8 mg/mL Injection, Solution, 1 vial — NDC 58151-395-31 (Billing 58151-0395-31)

by Viatris Specialty LLC · 1 VIAL in 1 CARTON / 12.5 mL in 1 VIAL

This is a package of 1 vial of Revatio sildenafil citrate .8 mg/mL Injection, Solution from Viatris Specialty LLC, marketed since Apr 2025 and currently FDA-listed. It is this product's only package size.

NDC 58151-0395-31
🏷️ FDA NDC (as labeled) 58151-395-31 billing pads the product segment with a zero
Rx only Brand 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

NDC database record

One package, one record: these facts belong to NDC 58151-395-31 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
58151 labeler · 395 product · 31 package
Package marketed since
Apr 9, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5815139531 6
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 58151-395-31
Product NDC 58151-395
11-digit billing NDC 58151039531
NCPDP billing unit ML — per mL (volume)
RxCUI 577033, 581645, 882527, 882530, 1307427, 1307431
UNII BW9B0ZE037
Application # NDA022473
SPL Set ID 3bb9363e-b28d-4019-8aae-539233dca214
Established class (EPC) Phosphodiesterase 5 Inhibitor
Mechanism of action Phosphodiesterase 5 Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-04-09
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance SILDENAFIL CITRATE
TE code (Orange Book) AP · RLD · RS

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

GPI-14 40143060102020
GCN Seq No 066092
GCN 28273
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 REVATIO 10 MG/12.5 ML VIAL
FDB brand name Revatio
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 066092
  • GCN: 28273
  • GPI-14 (Medi-Span): 40143060102020
  • HICL (First Databank): 018084
  • AHFS class code: 24:08.12.00
  • RxCUI (RxNorm): 577033
Why two NDCs? The FDA registers this code as 58151-395-31 — 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 → 58151-0395-31. 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 REVATIO 10 MG/12.5 ML VIAL 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 mLPer 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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
58151-0395-31 You're viewing this Main listing 1 VIAL in 1 CARTON / 12.5 mL in 1 VIAL 2025-04-09 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sildenafil 10 mg/12.5mL 55150-0166-13 Eugia 1 vial — AP FDA listed —
Revatio .8 mg/mLthis 58151-0395-31 Viatris 1 vial — AP FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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

🏛️
2009
First FDA approval
Nov 2009
📍
2026
Currently FDA-listed
17 years listed
🔓
·
Listed protection lapsed
listed protections lapsed 2026
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

🛡️ Latest patent/protection date listed: The latest listed FDA patent/protection lapsed Jan 2026 — those protections no longer apply, though a generic still needs FDA approval and a manufacturer to market it.
📅 FDA approved Nov 18, 2009 AP TE-rated RLD RS

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
Exclusivity M-287
2009 2011 2013 2015 2017 2019 2021 2023 2025
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

FDA exclusivity
CodeWhat it grantsExpires
M-287New indication / labeling change (3-year)Jan 31, 2026
Common questions
Is there a generic version of REVATIO 10 MG/12.5 ML VIAL?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for REVATIO 10 MG/12.5 ML VIAL. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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
ImprintRVT;20;VLE
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 IY9XDZ35W2
    Dextrose is a simple sugar derived from corn or other sources. It serves as a filler and sweetener in medicines to add bulk, improve taste, and help stabilize the medication's form.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

2 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

LabelerViatris Specialty LLC
Application holderVIATRIS SPECIALTY LLC
FDA applicationNDA022473 (NDA)
Labeler code58151
First marketedApr 2025
Product typeHuman Prescription Drug
Portfolio120 products on file

More NDCs from Viatris Specialty LLC labeler code 58151

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 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 188 words ▾

1 INDICATIONS AND USAGE Adults REVATIO is 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 Patients (1 to 17 Years Old) REVATIO is indicated in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standardized exercise testing, pulmonary hemodynamics thought to underlie improvements in exercise [see Clinical Studies (14) ] .

Adults REVATIO is a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening. ( 1 ) Pediatric Patients (1 to 17 years old) REVATIO is indicated in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standard exercise testing, pulmonary hemodynamics thought to underlie improvements in exercise ( 1 , 14 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION • Adults: 20 mg orally three times a day. Dose may be increased based on symptoms and tolerability. ( 2.1 ) • Pediatric patients ( 2.2 ) o ≤ 20 kg: 10 mg three times a day o 20 kg to 45 kg: 20 mg three times a day o > 45 kg: 20 mg three times a day. Dose may be increased based on symptoms and tolerability. • Injection (Adults): 10 mg three times a day administered as an intravenous bolus injection. ( 2.1 )

2.1Recommended Dosage in Adults Oral Dosage The recommended dosage of REVATIO 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) ] .

Intravenous Dosage The recommended dose is 10 mg administered as an intravenous bolus injection three times a day. The dose of REVATIO injection does not need to be adjusted for body weight. A 10-mg dose of REVATIO injection is predicted to provide pharmacological effect of sildenafil and its N-desmethyl metabolite equivalent to that of a 20-mg oral dose.

2.2Recommended Dosage in Pediatric Patients Oral Dosage The recommended dosage in patients ≤ 20 kg is 10 mg three times a day. For pediatric patients 20 kg to 45 kg, the recommended dosage is 20 mg three times a day. For pediatric patients 45 kg and greater, the recommended dosage is 20 mg three times a day.

A maximum dose in pediatric patients has not been identified. Based on the experience in adults, dose may be titrated to a maximum of 40 mg three times a day for pediatric patients > 45 kg, if required, based on symptoms and tolerability [see Clinical Studies (14) ] .

2.3Reconstitution of the Powder for Oral Suspension Note: Reconstitute the contents of the bottle with a total volume of 90 mL (60 mL followed by 30 mL) . Refer to the detailed instructions below. 1.

Tap the bottle to loosen the powder. 2. Add 60 mL of water to the bottle.

3. Replace the cap and shake the bottle vigorously for a minimum of 30 seconds. 4.

Add another 30 mL of water to the bottle. 5. Replace the cap and shake the bottle vigorously for a minimum of 30 seconds.

6. Remove cap and press the bottle adaptor into the neck of the bottle. Replace the cap on the bottle.

7. Write the expiration date of the reconstituted oral suspension on the bottle label (the expiration date of the reconstituted oral suspension is 60 days from the date of reconstitution). Incompatibilities Do not mix with any other medication or additional flavoring agent.

💊 Dosage Forms and Strengths 148 words ▾

3 DOSAGE FORMS AND STRENGTHS REVATIO Tablets White to off-white, film-coated, round tablets engraved with “RVT 20” on one side and “VLE” on the other side. Each tablet contains sildenafil citrate equivalent to 20 mg of sildenafil. REVATIO for Oral Suspension White to slight pink powder containing 1.57 g of sildenafil citrate (equivalent to 1.12 g sildenafil) in a bottle for reconstitution to 10 mg/mL.

Following reconstitution with 90 mL of water, the total volume of the oral suspension is 112 mL. A 2 mL oral dosing syringe (with 1 mL and 2 mL dose markings) and a press-in bottle adaptor are also provided. REVATIO Injection Single-dose vial containing 10 mg/12.5 mL (0.8 mg/mL) of sildenafil. • Tablets: 20 mg ( 3 ) • For oral suspension: 10 mg/mL (when reconstituted) ( 3 ) • Injection: 10 mg/12.5 mL (0.8 mg/mL) in a single-dose vial ( 3 )

⛔ Contraindications 120 words ▾

4 CONTRAINDICATIONS REVATIO is 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, injection, or oral suspension. 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, injection, or oral suspension. ( 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: REVATIO may cause serious vaso-occlusive crises. ( 5.8 )

5.1Hypotension REVATIO has vasodilatory properties, resulting in mild and transient decreases in blood pressure. Before prescribing REVATIO, 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 REVATIO.

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

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

The safety of REVATIO 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 REVATIO.

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

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

5.7Priapism Use REVATIO with caution in patients with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, or Peyronie’s disease) or in patients who have… [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 ) Children: Priapism. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) 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 REVATIO-treated adults with PAH (WHO Group I) [see Clinical Studies (14) ] the adverse reactions that were reported by at least 10% of REVATIO-treated patients in any dosing group, and were more frequent in REVATIO-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 REVATIO-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 REVATIO 20 mg, 40 mg, 80 mg and Placebo Three Times Per Day in SUPER-1 (More Frequent in REVATIO-Treated Patients than Placebo-Treated Patients) REVATIO 20 mg (n = 69) REVATIO 40 mg (n = 67) REVATIO 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 REVATIO (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 REVATIO + 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 Patients REVATIO was studied in a total of 234 PAH pediatric patients 1 to 17 years of age in a 16‑week, double-blind placebo‑controlled study (STARTS-1); 220 patients continued in a long-term extension study (STARTS-2). Erection increased was observed in 9% of patients treated with sildenafil in STARTS-1. No other new adverse reactions were identified in pediatric patients [see Use in Specific Populations (8.4) ] .

REVATIO Injection Adverse events with REVATIO injection were similar to those seen with oral tablets.

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 relation… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 130 words ▾

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

Dose up-titration of REVATIO may be needed when initiating treatment with moderate-to-strong CYP3A inducers. Reduce the dose of REVATIO 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 )

👥 Use in Specific Populations ~3 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/m 2 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 REVATIO to an infant during lactation.

8.4Pediatric Use The safety and efficacy of REVATIO have been established in pediatric patients 1 to 17 years old, for the treatment of PAH (WHO Group I) to improve exercise ability and, in patients too young to perform standard exercising testing, pulmonary hemodynamics thought to underlie improvements in exercise. Use of REVATIO for this indication is supported by evidence from adequate and well-controlled studies in adults with additional PK and safety data in pediatric patients aged 1 year and older [see Adverse Reactions (6.1) , Clinical Studies (14) ] .

The safety and effectiveness of REVATIO have not been established in pediatric patients younger than 1 year of age. During the conduct of the pediatric studies (STARTS-1 and STARTS-2) [see Clinical Studies (14) ] , an imbalance in the number of deaths was noted: 5/55 (9.1%), 10/74 (13.5%), and 22/100 (22%) in the sildenafil low, medium, and high dose groups, respectively. The causes of death were related to the progression of PAH.

This safety observation in pediatrics was not confirmed in a study conducted in adults designed to evaluate this risk (Study A1481324). Given the beneficial effects on clinical worsening and death observed in adults with increasing doses (Study A1481324) and the expected similarity of disease in pediatrics and adults, a causal association for the observed dose-related effect on mortality in pediatric patients is unlikely, and therefore, the available data support dosing in pediatric patients > 45 kg up to a maximum of 40 mg three times a day.

8.5Geriatric Use Clinical studies of REVATIO 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 t… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

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/m 2 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).

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use The safety and efficacy of REVATIO have been established in pediatric patients 1 to 17 years old, for the treatment of PAH (WHO Group I) to improve exercise ability and, in patients too young to perform standard exercising testing, pulmonary hemodynamics thought to underlie improvements in exercise. Use of REVATIO for this indication is supported by evidence from adequate and well-controlled studies in adults with additional PK and safety data in pediatric patients aged 1 year and older [see Adverse Reactions (6.1) , Clinical Studies (14) ] .

The safety and effectiveness of REVATIO have not been established in pediatric patients younger than 1 year of age. During the conduct of the pediatric studies (STARTS-1 and STARTS-2) [see Clinical Studies (14) ] , an imbalance in the number of deaths was noted: 5/55 (9.1%), 10/74 (13.5%), and 22/100 (22%) in the sildenafil low, medium, and high dose groups, respectively. The causes of death were related to the progression of PAH.

This safety observation in pediatrics was not confirmed in a study conducted in adults designed to evaluate this risk (Study A1481324). Given the beneficial effects on clinical worsening and death observed in adults with increasing doses (Study A1481324) and the expected similarity of disease in pediatrics and adults, a causal association for the observed dose-related effect on mortality in pediatric patients is unlikely, and therefore, the available data support dosing in pediatric patients > 45 kg up to a maximum of 40 mg three times a day.

🧓 Geriatric Use 79 words ▾

8.5Geriatric Use Clinical studies of REVATIO 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) ] .

🆘 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 REVATIO on Hemodynamic Measures Adults Patients on all REVATIO 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 REVATIO 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 REVATIO 20 mg Three Times a Day and Placebo Group mPAP = mean pulmonary arterial pressure; PVR = pulmonary vascular resistance; SVR = systemic vascular resistance; RAP = right atrial pressure; CO = cardiac output; HR = heart rate. Placebo (n = 65) The number of patients per treatment group varied slightly for each parameter due to missing assessments.

REVATIO 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) Pediatric Patients Patients on REVATIO medium and high dose groups achieved dose related improvements in pulmonary vascular resistance index (PVRI) and mean pulmonary arterial pressure (mPAP) compared to those on placebo [see STARTS-1 in Clinical Studies (14) ] .

Improvements were observed with cardiac index in all three REVATIO dose groups over placebo. Data on other hemodynamic measures for the REVATIO low, medium and high dose groups compared to placebo is displayed in Table 3. Table 3.

Placebo Corrected Changes in Hemodynamic Parameters by Dose Group Abbreviations: CI = cardiac index; HR = heart rate; mPAP = mean pulmonary arterial pressure; PVRI = pulmonary vascular resistance index; RAP = right atrial pressure; SVRI = systemic vascular resistance index. Note: n = 52, 56, 55, 54, 56, and 56 placebo patients for PVRI, mPAP, CI, SVRI, RAP and HR, respectively. Parameter [Estimate (95% CI)] Low Dose Medium Dose High Dose PVRI (%) -2% (-20%, 20%) n = 37 -18% (-32%, -2%) n = 51 -27% (-39%, -14%) n = 68 mPAP (mmHg) 1.6 (-4.5, 7.6) n = 39 -3.5 (-8.9, 1.9) n = 55 -7.3 (-12.4, -2.1) n = 71 CI (%) 10% (-4%,… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action ~1 min read ▾

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 .

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING REVATIO tablets are supplied as white to off-white, film-coated, round tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows: REVATIO Tablets Package Configuration Strength NDC Engraving on Tablet Bottle of 90 Tablets 20 mg 58151-402-77 “RVT 20” on one side and “VLE” on the other side Recommended Storage for REVATIO Tablets: Store at controlled room temperature 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] .

REVATIO injection is supplied as a clear, colorless, sterile, ready to use solution containing 10 mg sildenafil/12.5 mL (0.8 mg/mL) presented in a single-dose glass vial. REVATIO Injection Package Configuration Strength NDC Vial individually packaged in a carton 10 mg/12.5 mL (0.8 mg/mL) 58151-395-31 Recommended Storage for REVATIO Injection: Store at controlled room temperature 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] . Discard unused portion.

REVATIO powder for oral suspension is supplied in amber glass bottles. Each bottle contains white to slight pink powder containing 1.57 g of sildenafil citrate (equivalent to 1.12 g sildenafil). Following reconstitution, the total volume of the oral suspension is 112 mL (10 mg sildenafil/mL).

A 2 mL oral dosing syringe (with 1 mL and 2 mL dose markings) and a press-in bottle adaptor are also provided. REVATIO Powder for Oral Suspension Package Configuration Strength NDC Powder for oral suspension - bottle 10 mg/mL (when reconstituted) 58151-385-35 Recommended Storage for REVATIO for Oral Suspension: Store below 30°C (86°F) in the original package in order to protect from moisture. Recommended Storage for Reconstituted Oral Suspension: Store below 30°C (86°F) or in refrigerator at 2°C to 8°C (36°F to 46°F).

Do not freeze. The shelf-life of the reconstituted oral suspension is 60 days. Any remaining oral suspension should be discarded 60 days after reconstitution.

📋 Description ~1 min read ▾

11 DESCRIPTION REVATIO, 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 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.

REVATIO (sildenafil) Tablets: REVATIO is formulated as white to off-white, film-coated, round tablets for oral administration. Each tablet contains sildenafil citrate equivalent to 20 mg of sildenafil. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: anhydrous dibasic calcium phosphate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin.

REVATIO (sildenafil) Injection: REVATIO is supplied as a clear, colorless, sterile, ready to use solution in a single-dose vial containing 10 mg/12.5 mL of sildenafil. Each mL of solution contains 1.124 mg sildenafil citrate (equivalent to 0.8 mg sildenafil), 50.5 mg dextrose, and water for injection. REVATIO (sildenafil) for Oral Suspension: REVATIO is supplied as white to slight pink powder containing 1.57 g of sildenafil citrate (equivalent to 1.12 g sildenafil) in an amber glass bottle intended for reconstitution.

Following reconstitution with 90 mL water, the total volume of the oral suspension is 112 mL and the oral suspension contains 10 mg/mL sildenafil. The inactive ingredients include citric acid anhydrous, colloidal silicon dioxide anhydrous, grape flavor, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose, titanium dioxide, and xanthan gum. In addition to the bottle, a press-in bottle adapter and an oral dosing syringe (with 1 mL and 2 mL dose markings) are provided.

Sildenafil Citrate Structural Formula

💬 Information for Patients 146 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). • Inform patients of contraindication of REVATIO with regular and/or intermittent use of organic nitrates. • Inform patients that sildenafil is also marketed as VIAGRA for erectile dysfunction. Advise patients taking REVATIO 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 REVATIO.

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 REVATIO. These events may be accompanied by tinnitus and dizziness. Distributed by: Viatris Specialty LLC Morgantown, WV 26505 U.S.A. © 2024 Viatris Inc.

REVATIO is a registered trademark of Viatris Specialty LLC, a Viatris Company. UPJ:RVTTOSI:R2

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Absorption and Distribution REVATIO is rapidly absorbed after oral administration, with a mean absolute bioavailability of 41% (25 to 63%). Maximum observed plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state. When REVATIO is taken with a high-fat meal, the rate of absorption is reduced, with a mean delay in T max of 60 minutes and a mean reduction in C max of 29%.

The mean steady state volume of distribution (Vss) for sildenafil is 105 L, indicating distribution into the tissues. Sildenafil and its major circulating N-desmethyl metabolite are both approximately 96% bound to plasma proteins. Protein binding is independent of total drug concentrations.

Bioequivalence was established between the 20 mg tablet and the 10 mg/mL oral suspension when administered as a 20 mg single oral dose of sildenafil (as citrate). Metabolism and Excretion Sildenafil is cleared predominantly by the CYP3A (major route) and cytochrome P450 2C9 (CYP2C9, minor route) hepatic microsomal isoenzymes. The major circulating metabolite results from N-desmethylation of sildenafil, and is, itself, further metabolized.

This metabolite has a phosphodiesterase selectivity profile similar to sildenafil and an in vitro potency for PDE-5 approximately 50% of the parent drug. In healthy volunteers, plasma concentrations of this metabolite are approximately 40% of those seen for sildenafil, so that the metabolite accounts for about 20% of sildenafil’s pharmacologic effects. In patients with PAH, however, the ratio of the metabolite to sildenafil is higher.

Both sildenafil and the active metabolite have terminal half-lives of about 4 hours. After either oral or intravenous administration, sildenafil is excreted as metabolites predominantly in the feces (approximately 80% of the administered oral dose) and to a lesser extent in the urine (approximately 13% of the administered oral dose). REVATIO Injection: The pharmacokinetic profile of REVATIO has been characterized following intravenous administration.

A 10 mg dose of REVATIO Injection is predicted to provide a pharmacological effect of sildenafil and its N-desmethyl metabolite equivalent to that of a 20 mg oral dose. Population Pharmacokinetics Age, gender, race, and renal and hepatic function were included as factors assessed in the population pharmacokinetic model to evaluate sildenafil pharmacokinetics in patients with PAH. The dataset available for the population pharmacokinetic evaluation contained a wide range of demographic data and laboratory parameters associated with hepatic and renal function.

None of these factors had a significant impact on sildenafil pharmacokinetics in patients with PAH. In patients with PAH, the average steady-state concentrations were 20 to 50% higher when compared to those of healthy volunteers. There was also a doubling of C min levels compared to healthy volunteers.

Both findings suggest a lower clearance and/or a higher oral bioavailability of sildenafil in patients with PAH compared to healthy volunteers. Pediatric Patients Body weight was shown to be a good predictor of drug exposure in children. Sildenafil plasma concentration half-life values were estimated to range from 2.9 to 4.4 hours for a range of 10 to 70 kg of body weight.

T max was estimated at approximately 1 hour. Geriatric Patients Healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil, resulting in approximately 84% and 107% higher plasma concentrations of sildenafil and its active N-desmethyl metabolite, respectively, compared to those seen in healthy younger volunteers (18 to 45 years). Due to age-differences in plasma protein binding, the corresponding increase in the AUC of free (unbound) sildenafil and its active N-desmethyl metabolite were 45% and 57%, respectively.

Renal Impairment In volunteers with mild (CLcr = 50-80 mL/min) and moderate (CLcr = 30-49 mL/min) renal impairment, the pharmacokine… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics ~3 min read ▾

12.2Pharmacodynamics Effects of REVATIO on Hemodynamic Measures Adults Patients on all REVATIO 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 REVATIO 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 REVATIO 20 mg Three Times a Day and Placebo Group mPAP = mean pulmonary arterial pressure; PVR = pulmonary vascular resistance; SVR = systemic vascular resistance; RAP = right atrial pressure; CO = cardiac output; HR = heart rate. Placebo (n = 65) The number of patients per treatment group varied slightly for each parameter due to missing assessments.

REVATIO 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) Pediatric Patients Patients on REVATIO medium and high dose groups achieved dose related improvements in pulmonary vascular resistance index (PVRI) and mean pulmonary arterial pressure (mPAP) compared to those on placebo [see STARTS-1 in Clinical Studies (14) ] .

Improvements were observed with cardiac index in all three REVATIO dose groups over placebo. Data on other hemodynamic measures for the REVATIO low, medium and high dose groups compared to placebo is displayed in Table 3. Table 3.

Placebo Corrected Changes in Hemodynamic Parameters by Dose Group Abbreviations: CI = cardiac index; HR = heart rate; mPAP = mean pulmonary arterial pressure; PVRI = pulmonary vascular resistance index; RAP = right atrial pressure; SVRI = systemic vascular resistance index. Note: n = 52, 56, 55, 54, 56, and 56 placebo patients for PVRI, mPAP, CI, SVRI, RAP and HR, respectively. Parameter [Estimate (95% CI)] Low Dose Medium Dose High Dose PVRI (%) -2% (-20%, 20%) n = 37 -18% (-32%, -2%) n = 51 -27% (-39%, -14%) n = 68 mPAP (mmHg) 1.6 (-4.5, 7.6) n = 39 -3.5 (-8.9, 1.9) n = 55 -7.3 (-12.4, -2.1) n = 71 CI (%) 10% (-4%, 26%) n = 37 4% (-7%, 18%) n = 51 15% (3%, 29%) n = 69 SVRI (%) -9% (-22%, 7%) n = 37 -5% (-17%, 10%) n = 50 -16% (-26%, -4%) n = 68 RAP (mmHg) -0.17 (-1.91, 1.57) n = 39 -0.19 (-1.73, 1.36) n = 55 -1.14 (-2.61, 0.33) n = 71 HR (%) 3% (-5%, 12%) n = 39 2% (-5%, 9%) n = 55 -2% (-9%, 5%) n = 71 Effects of REVATIO 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 9.0 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 pressur… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES SUPER-1 (NCT00644605) - REVATIO Monotherapy [20 mg, 40 mg, and 80 mg Three Times a Day] A randomized, double-blind, placebo-controlled study of REVATIO (SUPER-1) was conducted in 277 patients with PAH (defined as a mean pulmonary artery pressure ≥ 25 mmHg at rest with a pulmonary capillary wedge pressure < 15 mmHg). Patients were predominantly 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. Patients 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 REVATIO 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 45-50 meters were observed with all doses of REVATIO. These increases were significantly different from placebo, but the REVATIO dose groups were not different from each other (see Figure 3), 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 3. Change from Baseline in 6-Minute Walk Distance (meters) at Weeks 4, 8, and 12 in SUPER-1: Mean (95% Confidence Interval) Figure 4 displays subgroup efficacy analyses in SUPER-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 4. Placebo-Corrected Change from Baseline in 6-Minute Walk Distance (meters) at Week 12 by Study Subpopulation in SUPER-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. SUPER-2 (NCT00159887) Long-Term Treatment of PAH In a long-term follow-up of patients who were treated with sildenafil (n = 277), K-M estimates of survival at 1, 2, and 3 years were 94%, 88% , and 79%, respectively.

These uncontrolled observations do not allow comparison with a group not given sildenafil and cannot be used to determine the long term-effect of sildenafil on mortality. PACES-1 (NCT00159861) - REVATIO Co-Administered with Epoprostenol A randomized, double-blind, placebo‑controlled study (PACES-1) 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 REVATIO (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 patients had PPH (80%) or PAH secondary to CTD (20%); WHO Functional Class I (1%), II (26%), III (67%), or IV (6… [Excerpted — this section continues on DailyMed.]

🧪 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 REVATIO ® (re-VAH-tee-oh) (sildenafil) tablets REVATIO ® (re-VAH-tee-oh) (sildenafil) oral suspension What is the most important information I should know about REVATIO? Never take REVATIO 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 or your child are taking a nitrate or a guanylate cyclase stimulator medicine. See “What are the possible side effects of REVATIO?” for more information about side effects. What is REVATIO?

REVATIO is a prescription medicine used to treat pulmonary arterial hypertension (PAH). PAH is a type of high blood pressure in the arteries of your lungs. REVATIO may be used in: • adults to improve your ability to exercise and help slow down the worsening of your physical condition. • children 1 to 17 years old to improve their ability to exercise, and in children too young to do certain exercise and lung testing.

It is not known if REVATIO is safe and effective in children younger than 1 year of age. Do not take REVATIO if you or your child: • take medicines called nitrates. • take riociguat, a guanylate cyclase stimulator medicine. • are allergic to sildenafil or any of the ingredients in REVATIO. See the end of this leaflet for a complete list of ingredients in REVATIO.

Before taking REVATIO, tell your healthcare provider about all of your medical conditions, including if you or your child: • 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 REVATIO 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 REVATIO will harm your unborn baby. • are breastfeeding or plan to breastfeed. REVATIO 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 REVATIO. Tell your healthcare provider about all of the medicines you or your child take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. REVATIO and certain other medicines may affect each other and can cause side effects.

Especially tell your healthcare provider if you or your child take: • nitrates or guanylate cyclase stimulators. See “ What is the most important information I should know about REVATIO? ” • medicines to treat high blood pressure • medicines for erectile dysfunction (impotence). REVATIO 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 REVATIO. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

Know the medicines you or your child take. Keep a list of your or your child’s medicines and show it to your healthcare provider and pharmacist when you get a new medicine. How should I take REVATIO? • Take or give REVATIO exactly as your healthcare provider… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

Instructions for Use REVATIO ® (re-VAH-tee-oh) (sildenafil) oral suspension Read this Instructions for Use before you start taking REVATIO oral suspension or giving REVATIO oral suspension to your child and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your or your child’s medical condition or treatment.

Important information: • Ask your healthcare provider or pharmacist to show you how to measure and take or give your child’s prescribed dose of REVATIO oral suspension. • Your pharmacist will mix (reconstitute) REVATIO oral suspension before it is given to you. Do not take or give REVATIO oral suspension and contact your pharmacist if the medicine in the bottle is still a powder. • Always use the oral dosing syringe that comes with REVATIO oral suspension. If your carton does not come with an oral dosing syringe, contact your pharmacist. • Do not take or give REVATIO oral suspension if the bottle adaptor is not in the bottle.

If the bottle adaptor is not in the bottle, contact your pharmacist. • REVATIO oral suspension should not be mixed with any other medicine or flavoring. Supplies you will need to take or give a dose of REVATIO oral suspension (See Figure A): • 1 bottle of REVATIO oral suspension with pre-inserted bottle adaptor • 1 oral dosing syringe (provided in the carton) Step 1. Shake the bottle of REVATIO oral suspension for 10 seconds before each use.

(See Figure B) Step 2. Remove the cap. Open the bottle by pushing down on the cap and twisting it in the direction of the arrow (counter-clockwise).

(See Figure C) Step 3. Fully push down (depress) the plunger of the oral dosing syringe. Then insert the tip of the oral dosing syringe into the bottle adaptor while holding the bottle upright, on a flat surface.

(See Figure D) Step 4. Turn the bottle upside down while holding the oral dosing syringe in place. Slowly pull back the plunger of the oral dosing syringe until the bottom of the plunger is even with the mL marking on the syringe for your or your child’s prescribed dose.

(See Figure E) If your or your child’s dose of REVATIO oral suspension is more than 2 mL (20 mg), you will need to divide the dose. Follow the instructions given to you by your healthcare provider or pharmacist about how to prepare the divided dose. If you see air bubbles in the oral dosing syringe, slowly push the plunger all the way up so that REVATIO oral suspension flows back into the bottle and repeat Step 4.

Step 5. Turn the bottle back upright with the oral dosing syringe still in place. Place the bottle on a flat surface.

Remove the oral dosing syringe from the bottle adaptor by pulling straight up on the barrel of the oral dosing syringe. (See Figure F) Do not press on the plunger of the oral dosing syringe at this time. Step 6.

Put the tip of the oral dosing syringe into your or your child’s mouth and point it towards the inside of the cheek. Slowly push the plunger of the oral dosing syringe all the way down to give the entire dose. Do not squirt the medicine out quickly.

(See Figure G) If you are giving REVATIO oral suspension to a child, make sure they are in an upright position before giving the medicine. Step 7. Replace the cap on the bottle, leaving the bottle adaptor in place.

Turn the cap in the direction of the arrow (clockwise) to close the bottle. (See Figure H) Step 8. Wash the oral dosing syringe after each use.

Pull the plunger out of the barrel and rinse both parts with water. (See Figure I) Step 9. Dry all parts with a clean paper towel.

Push the plunger back into the barrel. Store the oral dosing syringe with the REVATIO oral suspension bottle. How should I store REVATIO? • Store mixed (reconstituted) REVATIO oral suspension below 86°F (30°C) or in a refrigerator between 36°F to 46°F (2°C to 8°C). • Do not freeze mixed REVATIO oral suspension. • Throw away (discard) any remaining REVATIO oral suspension 60 days after mixed… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel ~2 min read ▾

PRINCIPAL DISPLAY PANEL – 20 mg NDC 58151-402-77 Revatio ® (sildenafil) tablets 20 mg* Rx only 90 Tablets Store at controlled room temperature 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] . Dispense in tight containers (USP). DOSAGE AND USE See accompanying prescribing information. *Each tablet contains sildenafil citrate equivalent to 20 mg sildenafil.

Distributed by: Viatris Specialty LLC Morgantown, WV 26505 U.S.A. © 2024 Viatris Inc. Made in France RUPJ402MM Bottle Label Revatio 20 mg

PRINCIPAL DISPLAY PANEL – 10 mg/12.5 mL NDC 58151-395-31 Sterile Single-dose Vial Rx only Revatio ® (sildenafil) Injection 10 mg/12.5 mL (0.8 mg/mL) For Intravenous Use Sterile Single-dose Vial, Discard Unused Portion Store at controlled room temperature 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]. Each mL of solution contains 1.124 mg sildenafil citrate, 50.5 mg dextrose and Water for Injection. DOSAGE AND USE See accompanying prescribing information.

Distributed by: Viatris Specialty LLC Morgantown, WV 26505 U.S.A. © 2024 Viatris Inc. REVATIO is a registered trademark of Viatris Specialty LLC, a Viatris Company. Made in France UPJ:395:1C:R1 Carton Label Revatio 10 mg/12.5 mL

PRINCIPAL DISPLAY PANEL – 10 mg/mL NDC 58151-385-35 Rx only Revatio® (sildenafil) for oral suspension 10 mg/mL For Oral Use Only Shake Well Before Each Use RECONSTITUTION DIRECTIONS: Gently tap the bottle to loosen the powder. The total volume of water to be added is 90 mL. Add 60 mL of water and shake vigorously for at least 30 seconds.

Add another 30 mL of water and shake for at least another 30 seconds to obtain a uniform suspension. 112 mL following Reconstitution Grape Flavored Rx only BEFORE RECONSTITUTION: Recommended storage for Revatio powder for oral suspension: Store below 30°C (86°F) in the original package in order to protect from moisture. RECONSTITUTED SUSPENSION: Store below 30°C (86°F) or in refrigerator at 2°C to 8°C (36°F to 46°F).

Do not freeze. Discard any unused portion 60 days after reconstitution. Each mL of the suspension contains 10 mg of sildenafil (as citrate) when reconstituted with 90 mL water.

Each bottle contains 1.57 g of sildenafil citrate (1.12 g sildenafil). RECOMMENDED DOSAGE: See prescribing information. An oral dosing syringe, and a press-in bottle adaptor are also provided.

Distributed by: Viatris Specialty LLC Morgantown, WV 26505 U.S.A. © 2024 Viatris Inc. REVATIO is a registered trademark of Viatris Specialty LLC, a Viatris Company. Made in France UPJ:385:1C:R1 Carton Label Revatio 10 mg/mL

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Revatio — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Revatio. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$1.08M
Claims incl. refills
103
Beneficiaries
54
Spend / beneficiary
$19,925.91
Spend / claim
$10,446.60
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Viatris Specialty LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Viatris Specialty LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
58151-0402-77 · Viatris →
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.