Quick answers
- What is Tivicay PD?
- Tivicay PD is a brand name of Dolutegravir sodium, a prescription medicine. The FDA NDC Directory lists 1 Tivicay PD product in 1 strength and form.
- Who makes Tivicay PD?
- Viiv Hlthcare holds the FDA application for Tivicay PD (NDA213983, approved June 12, 2020).
- Is there a generic or store brand of Tivicay PD?
- Other products of Dolutegravir sodium are listed with the FDA, but none in exactly the same strength and form as a Tivicay PD product.
- Has Tivicay PD been recalled?
- FDA enforcement reports list 1 recall of Tivicay PD products; the newest started May 17, 2024. A recall usually concerns specific lots, not every product.
What Tivicay PD is
Each Tivicay PD 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 5 mg tablet, for suspension (oral) | Tivicay PD | None listed | — |
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 |
|---|---|---|---|
| NDA213983 | Viiv Hlthcare | June 12, 2020 | 1 |
Companies that list Tivicay PD
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Tivicay PD products.
- ViiV Healthcare Company1 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 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
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.