Quick answers
- What is Zidovudine used for?
- The FDA-approved label (Zidovudine, Coupler LLC, January 19, 2026) says: “Zidovudine tablets are a nucleoside analogue reverse transcriptase inhibitor indicated for: •Treatment of Human Immunodeficiency Virus (HIV-1) infection in combination with other antiretroviral agents. • Prevention of maternal-fetal HIV-1 transmission. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Zidovudine have a boxed warning?
- Yes. The FDA label for Zidovudine has a boxed warning (“WARNING: RISK OF HEMATOLOGICAL TOXICITY, MYOPATHY, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Zidovudine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Zidovudine been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Zidovudine?
- 4 companies list prescription products of Zidovudine in the FDA NDC Directory, including Aurobindo Pharma Limited, ViiV Healthcare Company and Coupler LLC.
What Zidovudine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Zidovudine tablets are a nucleoside analogue reverse transcriptase inhibitor indicated for: •Treatment of Human Immunodeficiency Virus (HIV-1) infection in combination with other antiretroviral agents. • Prevention of maternal-fetal HIV-1 transmission. …
— FDA label: Zidovudine, Coupler LLC, effective January 19, 2026. 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.
This label has a boxed warning. Its heading: WARNING: RISK OF HEMATOLOGICAL TOXICITY, MYOPATHY, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS
. Read it on the full label →
5 of 5 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule · Tablet · Injection, solution · Tablet, film coated · Syrup · Solution |
|---|---|
| Route | Oral · Intravenous |
| Prescription products | 8 in the FDA NDC Directory |
| Brand names | Retrovir |
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 |
|---|---|---|
| zidovudine 300 mg tablet | Generic | $0.4638 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.
- Aurobindo Pharma Limited3 products
- ViiV Healthcare Company3 products
- Coupler LLC1 product
- Camber 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 |
|---|---|---|---|
| NDA019655 RETROVIR | Viiv Hlthcare | March 19, 1987 | 42, latest December 18, 2024 2024: Labeling · 2020: Labeling · 2018: Labeling |
| NDA019910 RETROVIR | Viiv Hlthcare | September 28, 1989 | 36, latest December 18, 2024 2024: Labeling · 2020: Labeling · 2018: Labeling |
| NDA019951 RETROVIR | Viiv Hlthcare | February 2, 1990 | 30, latest November 11, 2024 2024: Manufacturing (CMC) · 2024: Manufacturing (CMC) · 2020: Labeling |
Generic approvals (4)
- ANDA077267Aurobindo · September 19, 2005
- ANDA077268Aurobindo · September 19, 2005
- ANDA078128Aurobindo Pharma Ltd · March 27, 2006
- ANDA090092Hetero Labs Ltd III · April 25, 2008
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
| RxCUI (RxNorm) | 198352, 199663, 756209 |
|---|---|
| SPL set ID of the quoted label | 437f55b2-f6d9-0065-e063-6294a90ab929 |
| FDA labels (SPL) | 5 |
| FDA applications | NDA019655, NDA019910, NDA019951, 4 ANDA |
| Active ingredients (FDA) | ZIDOVUDINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Zidovudine, Coupler LLC, effective January 19, 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 →