Quick answers
- What is Dolutegravir sodium and lamivudine used for?
- The FDA-approved label (Dovato, ViiV Healthcare Company, October 29, 2025) says: “DOVATO is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 25 kg with no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Dolutegravir sodium and lamivudine have a boxed warning?
- Yes. The FDA label for Dovato has a boxed warning (“WARNING: PATIENTS CO-INFECTED WITH HEPATITIS B VIRUS (HBV) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV-1): EMERGENCE OF LAMIVUDINE-RESISTANT HBV AND EXACERBATIONS OF HBV”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Dolutegravir sodium and lamivudine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Dolutegravir sodium and lamivudine been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Dolutegravir sodium and lamivudine?
- 1 company lists prescription products of Dolutegravir sodium and lamivudine in the FDA NDC Directory, including ViiV Healthcare Company.
What Dolutegravir sodium and lamivudine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
DOVATO is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 25 kg with no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known …
— FDA label: Dovato, ViiV Healthcare Company, effective October 29, 2025. Read the full label on DailyMed →
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: PATIENTS CO-INFECTED WITH HEPATITIS B VIRUS (HBV) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV-1): EMERGENCE OF LAMIVUDINE-RESISTANT HBV AND EXACERBATIONS OF HBV
. Read it on the full label →
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Dovato |
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 |
|---|---|---|
| dolutegravir sodium 50 mg · lamivudine 300 mg tablet, film coated | Brand: Dovato | $105.22 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.
- ViiV Healthcare Company1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA211994 DOVATO | Viiv Hlthcare | April 8, 2019 | 15, latest October 28, 2025 2025: Labeling · 2024: Labeling · 2024: Efficacy |
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) | 2122519, 2122526 |
|---|---|
| SPL set ID of the quoted label | 68e45422-43ed-4cfb-9356-fae88d14a53a |
| FDA labels (SPL) | 1 |
| FDA applications | NDA211994 |
| Active ingredients (FDA) | DOLUTEGRAVIR / LAMIVUDINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Dovato, ViiV Healthcare Company, effective October 29, 2025; 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 →