Quick answers
- What is Tivicay?
- Tivicay is a brand name of Dolutegravir sodium, a prescription medicine. The FDA NDC Directory lists 4 Tivicay products in 3 strengths and forms.
- Who makes Tivicay?
- Viiv Hlthcare holds the FDA application for Tivicay (NDA204790, approved August 12, 2013). 1 other company (repackagers or distributors) also list Tivicay products.
- Is there a generic or store brand of Tivicay?
- Other products of Dolutegravir sodium are listed with the FDA, but none in exactly the same strength and form as a Tivicay product.
- What do pharmacies pay for Tivicay?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 1 Tivicay strength and form (see the table below). That is what pharmacies pay to buy it, not what you pay: your price depends on your insurance and your pharmacy.
- Has Tivicay been recalled?
- FDA enforcement reports list 2 recalls of Tivicay products; the newest started May 13, 2022. A recall usually concerns specific lots, not every product.
What Tivicay is
Each Tivicay product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Dolutegravir sodium · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| dolutegravir sodium 10 mg tablet, film coated (oral) | Tivicay | None listed | — |
| dolutegravir sodium 25 mg tablet, film coated (oral) | Tivicay | None listed | — |
| dolutegravir sodium 50 mg tablet, film coated (oral) | Tivicay | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Dolutegravir sodium →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA204790 | Viiv Hlthcare | August 12, 2013 | 4 |
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 Tivicay
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Tivicay products.
- ViiV Healthcare Company3 products
- St. Mary's Medical Park Pharmacy1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
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
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.