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Prescription medicine · generic available

Sildenafil

Brand names: Viagra, Vybrique, Revatio

Also listed by the FDA as: sildenafil citrate · sildenafil

Drug class: Phosphodiesterase 5 Inhibitor

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
None listedFDA shortage list
0Recalls (FDA reports)
62Companies
1998First FDA approval on file

Quick answers

What is Sildenafil used for?
The FDA-approved label (Viagra, Viatris Specialty LLC, November 17, 2023) says: “VIAGRA is indicated for the treatment of erectile dysfunction. VIAGRA is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED)” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Sildenafil have a boxed warning?
No. None of the 155 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Sildenafil?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Sildenafil been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Sildenafil?
62 companies list prescription products of Sildenafil in the FDA NDC Directory, including NuCare Pharmaceuticals, Inc., Proficient Rx LP and Bryant Ranch Prepack.

What Sildenafil is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

VIAGRA is indicated for the treatment of erectile dysfunction. VIAGRA is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED)

— FDA label: Viagra, Viatris Specialty LLC, effective November 17, 2023. Read the full label on DailyMed →

The FDA has 155 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Erectile dysfunction

Related medical specialties

Urology

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 155 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsTablet, film coated · Tablet · Powder, for suspension · Film · For suspension · Injection, solution
RouteOral · Intravenous
Prescription products236 in the FDA NDC Directory
Brand namesViagra, Vybrique, Revatio

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Sildenafil, by strength and form
Strength and formGeneric or brandPharmacies pay
sildenafil 10 mg/mL
powder, for suspension		 Generic $0.2340 per mL
sildenafil citrate 10 mg/mL
for suspension		 Generic $0.2340 per mL
sildenafil citrate 10 mg/mL
powder, for suspension		 Generic $0.2340 per mL
sildenafil citrate 100 mg
tablet		 Generic $0.1365 per tablet
sildenafil citrate 100 mg
tablet, film coated		 Generic $0.1365 per tablet
sildenafil citrate 100 mg
tablet, film coated		 Brand: Viagra $83.70 per tablet
sildenafil citrate 20 mg
tablet		 Generic $0.0522 per tablet
sildenafil citrate 20 mg
tablet, film coated		 Generic $0.0522 per tablet
sildenafil citrate 25 mg
tablet		 Generic $0.1219 per tablet
sildenafil citrate 25 mg
tablet, film coated		 Generic $0.1219 per tablet
sildenafil citrate 50 mg
tablet		 Generic $0.1110 per tablet
sildenafil citrate 50 mg
tablet, film coated		 Generic $0.1110 per tablet

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA020895
VIAGRA		 ViatrisMarch 27, 1998 34, latest December 14, 2017
2017: Labeling · 2017: Labeling · 2015: Labeling
NDA021845
REVATIO		 ViatrisJune 3, 2005 18, latest December 16, 2024
2024: Manufacturing (CMC) · 2023: Efficacy · 2018: Labeling
NDA022473
REVATIO		 ViatrisNovember 18, 2009 12, latest December 16, 2024
2024: Manufacturing (CMC) · 2023: Efficacy · 2019: Labeling
NDA203109
REVATIO		 ViatrisAugust 30, 2012 13, latest October 25, 2024
2024: Manufacturing (CMC) · 2023: Efficacy · 2020: Labeling
NDA210858
VYBRIQUE		 IbsaDecember 16, 2025 —

Generic approvals (37)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

RxCUI (RxNorm)213269, 213270, 213271, 312950, 314228, 314229, 577033, 581645, 882527, 882530 … (+10)
SPL set ID of the quoted labeld905dc8d-917f-4ea3-a4ee-a1ecf6967d4e
FDA labels (SPL)155
FDA applicationsNDA020895, NDA021845, NDA022473, NDA203109, NDA210858, 37 ANDA
Active ingredients (FDA)SILDENAFIL

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Viagra, Viatris Specialty LLC, effective November 17, 2023; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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