Quick answers
- What is Atazanavir used for?
- The FDA-approved label (Reyataz, E.R. Squibb & Sons, L.L.C., December 5, 2024) says: “REYATAZ ® is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 3 months and older weighing at least 5 kg. Limitations of Use: • REYATAZ is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus […]. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Atazanavir have a boxed warning?
- No. None of the 5 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Atazanavir?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Atazanavir been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Atazanavir?
- 5 companies list prescription products of Atazanavir in the FDA NDC Directory, including Aurobindo Pharma Limited, Teva Pharmaceuticals USA, Inc. and Camber Pharmaceuticals, Inc..
What Atazanavir is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
REYATAZ ® is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 3 months and older weighing at least 5 kg. Limitations of Use: • REYATAZ is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus […]. …
— FDA label: Reyataz, E.R. Squibb & Sons, L.L.C., effective December 5, 2024. Read the full label on DailyMed →
The FDA has 5 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.
The label quoted above has no boxed warning.
0 of 5 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule · Capsule, gelatin coated · Powder |
|---|---|
| Route | Oral |
| Prescription products | 16 in the FDA NDC Directory |
| Brand names | Reyataz |
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 |
|---|---|---|
| atazanavir sulfate 200 mg capsule | Generic | $1.11 per capsule |
| atazanavir sulfate 300 mg capsule | Generic | $1.66 per capsule |
NADAC list of November 4, 2026; these prices took effect between August 19, 2026 and 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.
- Aurobindo Pharma Limited4 products
- Teva Pharmaceuticals USA, Inc.3 products
- Camber Pharmaceuticals, Inc.3 products
- E.R. Squibb & Sons, L.L.C.3 products
- Laurus Labs Limited3 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.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021567 REYATAZ | Bristol Myers Squibb | June 20, 2003 | 37, latest December 5, 2024 2024: Labeling · 2023: Labeling · 2023: Manufacturing (CMC) |
| NDA206352 REYATAZ | Bristol Myers Squibb | June 2, 2014 | 9, latest December 5, 2024 2024: Labeling · 2023: Labeling · 2020: Labeling |
Generic approvals (4)
- ANDA091673Teva Pharms USA · April 22, 2014
- ANDA204806Aurobindo Pharma · June 25, 2018
- ANDA212579Laurus · April 30, 2021
- ANDA212278Hetero Labs Ltd III · February 2, 2022
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Reyataz, E.R. Squibb & Sons, L.L.C., effective December 5, 2024; 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 →