Quick answers
- What is Dolutegravir sodium used for?
- The FDA-approved label (Tivicay, St. Mary'S Medical Park Pharmacy, May 22, 2026) says: “TIVICAY and TIVICAY PD are indicated in combination with other antiretroviral agents for the treatment of HIV‑1 infection in adults (treatment-naïve or -experienced) and in pediatric patients (treatment-naïve or -experienced but integrase strand transfer inhibitor [INSTI]-naïve) aged at least 4 weeks and weighing at least 3 kg […]. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Dolutegravir sodium have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Dolutegravir sodium?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Dolutegravir sodium been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started May 17, 2024 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Dolutegravir sodium?
- 2 companies list prescription products of Dolutegravir sodium in the FDA NDC Directory, including ViiV Healthcare Company and St. Mary's Medical Park Pharmacy.
What Dolutegravir sodium is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
TIVICAY and TIVICAY PD are indicated in combination with other antiretroviral agents for the treatment of HIV‑1 infection in adults (treatment-naïve or -experienced) and in pediatric patients (treatment-naïve or -experienced but integrase strand transfer inhibitor [INSTI]-naïve) aged at least 4 weeks and weighing at least 3 kg […]. …
— FDA label: Tivicay, St. Mary'S Medical Park Pharmacy, effective May 22, 2026. 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.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet, for suspension |
|---|---|
| Route | Oral |
| Prescription products | 5 in the FDA NDC Directory |
| Brand names | Tivicay, Tivicay Pd |
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 tablet, film coated | Brand: Tivicay | $77.64 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 Company4 products
- St. Mary's Medical Park Pharmacy1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA204790 TIVICAY | Viiv Hlthcare | August 12, 2013 | 23, latest August 25, 2026 2026: Efficacy · 2025: Labeling · 2024: Labeling |
| NDA213983 TIVICAY PD | Viiv Hlthcare | June 12, 2020 | 6, latest August 25, 2026 2026: Efficacy · 2025: Labeling · 2024: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
May 17, 2024 · Class III · Terminated · D-0544-2024
Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct expiration date, which is on the tablet bottle label, is 2025-APR.
Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Each carton contains one bottle of 60 tablets, one 30-mL dosing cup and one 10-mL oral dosing syringe, Rx Only, Mfd for: ViiV Healthcare Durham — GlaxoSmithKline LLC
-
May 13, 2022 · Class III · Terminated · D-0896-2022
Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product labeling with an expiration date of January 2027, whereas the correct expiration date is September 2026.
Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 49702-228-13. — GlaxoSmithKline LLC
-
February 11, 2014 · Class III · Terminated · D-1185-2014
Cross Contamination with Other Products: Product contains Promacta (eltrombopag).
Tivicay (dolutegravir) Tablets 50 mg, 30 Tablet Bottles, Rx Only. Manufactured for: ViiV Health, TRP, NC 27709; by: GlaxoSmithKline, Research Triangle Park, NC 27709. Made in Japan. NDC 49702-228-13 — Viiv Healthcare Company
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 1433873, 1433879 |
|---|---|
| SPL set ID of the quoted label | 485bc9db-8665-9f5a-e063-6394a90a7921 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA204790, NDA213983 |
| Active ingredients (FDA) | DOLUTEGRAVIR |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Tivicay, St. Mary'S Medical Park Pharmacy, effective May 22, 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 →