Quick answers
- What is Nelfinavir mesylate used for?
- The FDA-approved label (Viracept, Agouron, December 11, 2025) says: “VIRACEPT in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection. VIRACEPT is a protease inhibitor indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Nelfinavir mesylate have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Nelfinavir mesylate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Nelfinavir mesylate been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started July 8, 2014 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Nelfinavir mesylate?
- 1 company lists prescription products of Nelfinavir mesylate in the FDA NDC Directory, including Agouron.
What Nelfinavir mesylate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
VIRACEPT in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection. VIRACEPT is a protease inhibitor indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents.
— FDA label: Viracept, Agouron, effective December 11, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
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.
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Viracept |
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.
- Agouron2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020779 VIRACEPT | Agouron Pharms | March 14, 1997 | 55, latest March 24, 2021 2021: Labeling · 2016: Labeling · 2015: Labeling |
| NDA021503 VIRACEPT | Agouron Pharms | April 30, 2003 | 17, latest March 24, 2021 2021: Labeling · 2016: Labeling · 2015: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
July 8, 2014 · Class III · Terminated · D-1443-2014
Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect expiry date 11/2016. The correct expiry date is 09/2016.
VIRACEPT (R) (nelfinavir mesylate) Tablets, 625 mg, 120-count bottle, Rx only, Manufactured by: Agouron Pharmaceuticals, Inc. A Pfizer Company, Distributed by: ViV Healthcare Company, Research Triangle Park, NC 27709 NDC — Pfizer Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 212118, 311924, 403978, 542370 |
|---|---|
| SPL set ID of the quoted label | e72c2bc6-9462-4a2e-8e1d-b97592376cbd |
| FDA labels (SPL) | 1 |
| FDA applications | NDA020779, NDA021503 |
| Active ingredients (FDA) | NELFINAVIR |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Viracept, Agouron, effective December 11, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- 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 →