Quick answers
- What is Ritonavir used for?
- The FDA-approved label (Norvir, AbbVie Inc., July 23, 2026) says: “NORVIR tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. NORVIR oral powder is indicated in combination with other antiretroviral agents for the treatment of pediatric patients with HIV-1 infection. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ritonavir have a boxed warning?
- Yes. The FDA label for Norvir has a boxed warning (“WARNING: DRUG-DRUG INTERACTIONS LEADING TO POTENTIALLY SERIOUS AND/OR LIFE THREATENING REACTIONS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Ritonavir?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated July 24, 2026). Ask your pharmacist about alternatives.
- Has Ritonavir been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started March 15, 2021 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Ritonavir?
- 8 companies list prescription products of Ritonavir in the FDA NDC Directory, including AbbVie Inc., Bryant Ranch Prepack and Aurobindo Pharma Limited.
What Ritonavir is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
NORVIR tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. NORVIR oral powder is indicated in combination with other antiretroviral agents for the treatment of pediatric patients with HIV-1 infection. …
— FDA label: Norvir, AbbVie Inc., effective July 23, 2026. Read the full label on DailyMed →
The FDA has 8 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.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: DRUG-DRUG INTERACTIONS LEADING TO POTENTIALLY SERIOUS AND/OR LIFE THREATENING REACTIONS
. Read it on the full label →
8 of 8 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet · Powder |
|---|---|
| Route | Oral |
| Prescription products | 10 in the FDA NDC Directory |
| Brand names | Norvir |
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.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| ritonavir 100 mg tablet | Generic | $0.6075 per tablet |
| ritonavir 100 mg tablet, film coated | Generic | $0.6075 per tablet |
| ritonavir 100 mg tablet, film coated | Brand: Norvir | $8.35 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.
- AbbVie Inc.2 products
- Bryant Ranch Prepack2 products
- Aurobindo Pharma Limited1 product
- Amneal Pharmaceuticals LLC1 product
- American Health Packaging1 product
- Cipla USA Inc.1 product
- Camber Pharmaceuticals, Inc.1 product
- NuCare Pharmaceuticals, Inc.1 product
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.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022417 NORVIR | Abbvie | February 10, 2010 | 20, latest July 23, 2026 2026: Labeling · 2022: Labeling · 2020: Labeling |
| NDA209512 NORVIR | Abbvie | June 7, 2017 | 8, latest July 23, 2026 2026: Labeling · 2022: Labeling · 2020: Labeling |
Generic approvals (4)
- ANDA202573Cipla · January 15, 2015
- ANDA204587Hetero Labs Ltd III · September 17, 2018
- ANDA206614Aurobindo Pharma Ltd · September 17, 2018
- ANDA208890Amneal · September 17, 2018
Shortage status
To be discontinued · updated July 24, 2026 · first posted July 24, 2026
| Product | Norvir, Tablet, 100 mg (NDC 0074-2340-30) |
|---|---|
| Company | AbbVie Inc. |
Ask your pharmacist whether your product is affected and what the options are.
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.
-
March 15, 2021 · Class II · Terminated · D-0404-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Norvir Ritonavir Tablets 100 mg 30 Tablets Rx only NDC 0074-3333-30 Abbott Laboratories North Chicago, IL 60064, U.S.A. — Cardinal Health 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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Norvir, AbbVie Inc., effective July 23, 2026; 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 →