Prescription medicine
Lamivudine and zidovudine Brand names: Combivir
Lamivudine and zidovudine (Combivir) is a prescription medicine with an FDA approval on record since 1997. FDA's NDC Directory lists it from 7 generic labelers, and pharmacies paid $0.771 per lamivudine-zidovudine tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the lamivudine and zidovudine FDA label on DailyMed (effective August 22, 2023, ViiV Healthcare Company); the NDA 20857 record on Drugs@FDA; every lamivudine and zidovudine label on DailyMed.
Highlights of the record
FDA label of August 22, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
HEMATOLOGIC TOXICITY, MYOPATHY, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS,.
and EXACERBATIONS OF HEPATITIS B Zidovudine, a component of COMBIVIR (lamivudine and zidovudine) tablets, has been associated with hematologic toxicity including neutropenia and severe anemia, particularly in patients with advanced Human Immunodeficiency Virus (HIV ‑ 1) disease [see Warnings and Precautions ( 5.1 )]. Prolonged use of zidovudine has been associated with symptomatic myopathy [see Warnings and Precautions ( 5.2 )]. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues, including lamivudine and zidovudine (components of COMBIVIR). Discontinue COMBIVIR if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur [see Warnings and Precautions ( 5.3 )]. Severe acute exacerbations of hepatitis B have been reported in patients who are co ‑ infected with hepatitis B virus (HBV) and HIV ‑ 1 and have discontinued lamivudine, which is one component of COMBIVIR. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue COMBIVIR and are co ‑ infected with HIV ‑ 1 and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted [see Warnings and Precautions ( 5.4 )]. […]
Used for
From the label: indications and usageCOMBIVIR, a combination of 2 nucleoside analogues, is indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection.
Forms and strengths
- 150 mg / 300 mg
Film-coated tablet; tablet.
On the market
- Earliest approval on file
- September 26, 1997 Combivir, Viiv Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 12 first May 25, 2011; 6 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 8 of which 7 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.771 per tablet Lamivudine-zidovudine tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2015 0 Class I among all firms' recalls; latest March 2, 2015
- FAERS reports
- 7,703 through July 30, 2026
What is lamivudine and zidovudine used for?
From the label: indications and usageCOMBIVIR, a combination of 2 nucleoside analogues, is indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection. COMBIVIR, a combination of 2 nucleoside analogue reverse transcriptase inhibitors, is indicated in combination with other antiretroviral agents for the treatment of HIV‑1 infection.
Conditions named in the indications of lamivudine and zidovudine'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 (COMBIVIR), ViiV Healthcare Company, effective August 22, 2023 (SPL set 16da660b-9981-4d24-a14a-94c7744fce4f), via openFDA; the full label on DailyMed
Is there a generic for lamivudine and zidovudine (Combivir)?
The FDA approved the first generic lamivudine and zidovudine on May 25, 2011. 12 generic applications are approved; 6 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 6 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists lamivudine and zidovudine from 7 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1997 earliest approval on file
- 2011 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for lamivudine and zidovudine (Combivir)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.771 per Lamivudine-zidovudine tablet, up 16% from $0.667 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.
- Lamivudine-zidovudine tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Lamivudine-zidovudine tablet | Generic | $0.771 per tablet | $23.12 | +16% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has lamivudine and zidovudine been recalled?
The FDA's Enforcement Report lists 1 recall naming lamivudine and zidovudine since 2015: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 2, 2015 | Class II | American Health Packaging | Failed dissolution specifications |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the lamivudine and zidovudine label say about other medicines?
The lamivudine and zidovudine label names 1 other medicine 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 |
|---|---|---|
| Ribavirin | drug interactions | Nucleoside analogues, e.g., ribavirin Hematologic/Bone Marrow Suppressive/Cytotoxic Agents Coadministration with the following drugs may increase the hematologic toxicity of zidovudine: |
Source: FDA drug label (COMBIVIR), ViiV Healthcare Company, effective August 22, 2023 (SPL set 16da660b-9981-4d24-a14a-94c7744fce4f), via openFDA; the full label on DailyMed
What do FAERS reports show for lamivudine and zidovudine?
The FDA Adverse Event Reporting System holds 7,703 reports that list lamivudine and zidovudine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 594 are coded as a death and 2,265 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.
Reports received each year
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 lamivudine and zidovudine?
35 other medicines are given the same way (oral) and in the same FDA class as lamivudine and zidovudine 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 |
| Abacavir | HIV | 12 labelers | $0.546 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 |
| 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 lamivudine and zidovudine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to lamivudine and zidovudine
- 35 medicines for the same use
- Other hepatitis b virus nucleoside analog reverse transcriptase inhibitors
- the pharmacologic class, with prices and generics
- Lamivudine and zidovudine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other