ViiV Healthcare Company
NDC labeler code: 49702
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- Dolutegravir sodiumTivicay, Tivicay Pd · 4 products
- LamivudineEpivir · 3 products
- ZidovudineRetrovir · 3 products
- MaravirocSelzentry · 2 products
- Dolutegravir sodium and rilpivirine hydrochlorideJuluca · 1 product
- Cabotegravir sodiumVocabria · 1 product
- Abacavir sulfate, dolutegravir sodium, lamivudineTriumeq · 1 product
- Lamivudine and zidovudineCombivir · 1 product
- Dolutegravir sodium and lamivudineDovato · 1 product
- Fostemsavir tromethamineRukobia · 1 product
- AbacavirZiagen · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2024
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May 17, 2024 · Class III · Terminated · D-0544-2024 · Dolutegravir sodium
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
2022
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May 13, 2022 · Class III · Terminated · D-0896-2022 · Dolutegravir sodium
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.
2021
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March 15, 2021 · Class II · Terminated · D-0486-2021 · Abacavir sulfate, dolutegravir sodium, lamivudine
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Triumeq (abacavir, dolutegravir, and lamivudine) 600 mg/50 mg/300 mg Tablets 30 Tablets Rx Only NDC 49702-231-13 Manufactured for: Viiv Healthcare Research Triangle Park, NC 27709 by GlaxoSmithKline Research Triangle Par
2014
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February 11, 2014 · Class III · Terminated · D-1185-2014 · Dolutegravir sodium
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
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).
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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026