Prescription medicine
Abacavir and lamivudine First approved as Epzicom
Abacavir and lamivudine (Epzicom) is a prescription medicine with an FDA approval on record since 2004. FDA's NDC Directory lists it from 6 generic labelers, and pharmacies paid $1.48 per unit (Abacavir-lamivudine 600-300 mg) in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the abacavir and lamivudine FDA label on DailyMed (effective March 3, 2025, Macleods Pharmaceuticals Limited); the NDA 21652 record on Drugs@FDA; every abacavir and lamivudine label on DailyMed.
Highlights of the record
FDA label of March 3, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
HYPERSENSITIVITY.
REACTIONS and EXACERBATIONS OF HEPATITIS B Hypersensitivity Reactions Serious and sometimes fatal hypersensitivity reactions, with multiple organ involvement, have occurred with abacavir, a component of abacavir and lamivudine tablets Patients who carry the HLA-B*5701 allele are at a higher risk of a hypersensitivity reaction to abacavir; although, hypersensitivity reactions have occurred in patients who do not carry the HLA-B*5701 allele [see Warnings and Precautions ( 5.1 )]. Abacavir and lamivudine tablets is contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLA-B*5701-positive patients [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )]. All patients should be screened for the HLA-B*5701 allele prior to initiating therapy with abacavir and lamivudine tablets or reinitiation of therapy with abacavir and lamivudine tablets unless patients have a previously documented HLA-B*5701 allele assessment. Discontinue abacavir and lamivudine tablets immediately if a hypersensitivity reaction is suspected, regardless of HLA-B*5701 status and even when other diagnoses are possible [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )]. […]
Used for
From the label: indications and usageAbacavir and lamivudine tablets, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.
Forms and strengths
- 600 mg / 300 mg
Film-coated tablet.
On the market
- Earliest approval on file
- August 2, 2004 Epzicom, Viiv Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 9 first September 29, 2016; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 6 of which 6 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $1.48 per unit Abacavir-lamivudine 600-300 mg
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 196 through July 30, 2026
What is abacavir and lamivudine used for?
From the label: indications and usageAbacavir and lamivudine tablets, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Abacavir and lamivudine tablets, a combination of abacavir and lamivudine, both nucleoside analogue HIV-1 reverse transcriptase inhibitors, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Conditions named in the indications of abacavir and lamivudine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor and Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor.
Source: FDA drug label (Abacavir and Lamivudine), Macleods Pharmaceuticals Limited, effective March 3, 2025 (SPL set d36624c8-d773-4f99-81fc-433fae17feb3), via openFDA; the full label on DailyMed
What does the patient leaflet for abacavir and lamivudine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about abacavir and lamivudine tablets?Abacavir and lamivudine tablets can cause serious side effects, including: Serious allergic reactions (hypersensitivity reaction) that can cause death have happened with abacavir and lamivudine tablets and other abacavir-containing products. Your risk of this allergic reaction is much higher if you have a gene variation called HLA-B*5701. Your healthcare provider can determine with a blood test if you have this gene variation. If you get a symptom from 2 or more of the following groups while taking abacavir and lamivudine tablets, call your healthcare provider right away to find out if you should stop taking abacavir and lamivudine tablets. Symptom(s) Group 1 Fever Group 2 Rash Group 3 Nausea, vomiting, diarrhea, abdominal (stomach area) pain Group 4 Generally ill feeling, extreme tiredness, or achiness Group 5 Shortness of breath, cough, sore throat A list of these symptoms is on the Warning Card your pharmacist gives you. Carry this Warning Card with you at all times. If you stop abacavir and lamivudine tablets because of an allergic reaction, never take abacavir and lamivudine tablets or any other abacavir-containing medicine (TRIUMEQ, TRIZIVIR, or ZIAGEN) again. If you have an allergic reaction, dispose of any unused abacavir and lamivudine tablets. Ask your pharmacist how to properly dispose of medicines. If you take abacavir and lamivudine tablets or any other abacavir-containing medicine again after you have had an allergic reaction, within hours you may get life-threatening symptoms that may include very low blood pressure or death. If you stop abacavir and lamivudine tablets for any other reason, even for a few days, and you are not allergic to abacavir and lamivudine tablets, talk with your healthcare provider before taking them again. […]
From the patient leaflet: How should I store abacavir and lamivudine tablets?Store abacavir sulfate and lamivudine tablets at room temperature between 59° to 86°F (15° to 30°C). Keep abacavir and lamivudine tablets and all medicines out of the reach of children. General information for safe and effective use of abacavir and lamivudine tablets. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use abacavir and lamivudine tablets for a condition for which it was not prescribed. Do not give abacavir and lamivudine tablets to other people, even if they have the same symptoms that you have. They may harm them. You can ask your healthcare provider or pharmacist for the information about abacavir and lamivudine tablets that is written for health professionals.
Source: FDA drug label (Abacavir and Lamivudine), Aurobindo Pharma Limited, effective May 19, 2024 (SPL set deda1a24-2f51-4601-9881-347f47270940), via openFDA; the full label on DailyMed
Is there a generic for abacavir and lamivudine (Epzicom)?
The FDA approved the first generic abacavir and lamivudine on September 29, 2016. 9 generic applications are approved; 5 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 8 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists abacavir and lamivudine from 6 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2004 earliest approval on file
- 2016 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for abacavir and lamivudine (Epzicom)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.48 per unit (Abacavir-lamivudine 600-300 mg), down 5% from $1.57 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Abacavir-lamivudine 600-300 mg (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Abacavir-lamivudine 600-300 mg | Generic | $1.48 per unit | n/a | -5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the abacavir and lamivudine label say about other medicines?
The abacavir and lamivudine label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Methadone | drug interactions | An increased methadone dose may be required in a small number of patients. |
| Riociguat | drug interactions | The riociguat dose may need to be reduced. |
Source: FDA drug label (Abacavir and Lamivudine), Macleods Pharmaceuticals Limited, effective March 3, 2025 (SPL set d36624c8-d773-4f99-81fc-433fae17feb3), via openFDA; the full label on DailyMed
What do FAERS reports show for abacavir and lamivudine?
The FDA Adverse Event Reporting System holds 196 reports that list abacavir and lamivudine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 27 are coded as a death and 35 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as abacavir and lamivudine?
35 other medicines are given the same way (oral) and in the same FDA class as abacavir and lamivudine or labeled mainly for the same use (HIV), the same class first. HIV lists all 47 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Emtricitabine and tenofovir disoproxil | HIV | 25 labelers | $0.529 per tablet 200-300 mg tablet | No current entry |
| Tenofovir disoproxil | HIV | 15 labelers | $0.294 per tablet 300 mg tablet | No current entry |
| Efavirenz and emtricitabine and tenofovir disoproxil | HIV | 7 labelers | $1.12 per tablet 600-200-300 mg tablet | No current entry |
| Zidovudine | HIV | 3 labelers | $0.464 per tablet 300 mg tablet | No current entry |
| Bictegravir and emtricitabine and tenofovir alafenamide | HIV | none listed | $136.73 per tablet 50-200-25 mg tablet | No current entry |
| Emtricitabine | HIV | 2 labelers | $12.69 per capsule 200 mg capsule | A presentation being discontinued |
| Emtricitabine and rilpivirine and tenofovir disoproxil | HIV | 2 labelers | $114.50 per tablet 200-25-300 mg tablet | No current entry |
| Emtricitabine and tenofovir alafenamide | HIV | none listed | $74.94 per tablet 200-25 mg tablet | No current entry |
Every medicine labeled for the same conditions as abacavir and lamivudine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to abacavir and lamivudine
- 35 medicines for the same use
- Other hepatitis b virus nucleoside analog reverse transcriptase inhibitors
- the pharmacologic class, with prices and generics
- Abacavir and lamivudine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other