Quick answers
- What is Abacavir used for?
- The FDA-approved label (Ziagen, ViiV Healthcare Company, September 29, 2023) says: “ZIAGEN tablets and oral solution, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection. ZIAGEN, a nucleoside analogue human immunodeficiency virus (HIV-1) reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Abacavir have a boxed warning?
- Yes. The FDA label for Ziagen has a boxed warning (“WARNING: HYPERSENSITIVITY REACTIONS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Abacavir?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Abacavir been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Abacavir?
- 13 companies list prescription products of Abacavir in the FDA NDC Directory, including Camber Pharmaceuticals, Inc., Aurobindo Pharma Limited and Major Pharmaceuticals.
What Abacavir is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ZIAGEN tablets and oral solution, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection. ZIAGEN, a nucleoside analogue human immunodeficiency virus (HIV-1) reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
— FDA label: Ziagen, ViiV Healthcare Company, effective September 29, 2023. Read the full label on DailyMed →
The FDA has 13 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: HYPERSENSITIVITY REACTIONS
. Read it on the full label →
13 of 13 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet · Solution |
|---|---|
| Route | Oral |
| Prescription products | 15 in the FDA NDC Directory |
| Brand names | Ziagen |
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 |
|---|---|---|
| abacavir sulfate 300 mg tablet | Generic | $0.5523 per tablet |
| abacavir sulfate 300 mg tablet, film coated | Generic | $0.5523 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.
- Camber Pharmaceuticals, Inc.2 products
- Aurobindo Pharma Limited2 products
- Major Pharmaceuticals1 product
- XLCare Pharmaceuticals, Inc.1 product
- Rising Pharma Holdings, Inc.1 product
- ViiV Healthcare Company1 product
- Mylan Institutional Inc.1 product
- American Health Packaging1 product
- Cipla USA Inc.1 product
- Coupler LLC1 product
- Safecor Health LLC1 product
- AvPAK1 product
- Mylan 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 |
|---|---|---|---|
| NDA020978 ZIAGEN | Viiv Hlthcare | December 17, 1998 | 30, latest November 24, 2020 2020: Labeling · 2018: Labeling · 2018: Labeling |
Generic approvals (6)
- ANDA091294Mylan Pharms Inc · June 18, 2012
- ANDA077844Aurobindo Pharma Ltd · December 17, 2012
- ANDA091560Hetero Labs Ltd III · September 13, 2013
- ANDA201107Hetero Labs Ltd III · September 26, 2016
- ANDA078119Cipla · November 21, 2017
- ANDA077950Aurobindo Pharma Ltd · March 14, 2018
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) | 213461, 242679, 242680 |
|---|---|
| SPL set ID of the quoted label | ca73b519-015a-436d-aa3c-af53492825a1 |
| FDA labels (SPL) | 13 |
| FDA applications | NDA020978, 6 ANDA |
| Active ingredients (FDA) | ABACAVIR |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Ziagen, ViiV Healthcare Company, effective September 29, 2023; 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 →