Drug company (FDA labeler)
Sumitomo Pharma America, Inc.
NDC labeler codes: 63402, 72359, 72974, 73336
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
- Lurasidone hydrochlorideLatuda · 5 products
- Eslicarbazepine acetateAptiom · 4 products
- VibegronGemtesa · 1 product
- Allogenic thymocyte-depleted thymus tissue-agdcRethymic · 1 product
- RelugolixOrgovyx · 1 product
- Relugolix, estradiol hemihydrate, and norethindrone acetateMyfembree · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| May 26, 2021 | NDA214846 | Relugolix, estradiol hemihydrate, and norethindrone acetate MYFEMBREE | Sumitomo Pharma Am |
| December 23, 2020 | NDA213006 | Vibegron GEMTESA | Sumitomo Pharma Am |
| December 18, 2020 | NDA214621 | Relugolix ORGOVYX | Sumitomo Pharma Am |
| November 8, 2013 | NDA022416 | Eslicarbazepine acetate APTIOM | Sumitomo Pharma Am |
| October 28, 2010 | NDA200603 | Lurasidone hydrochloride LATUDA | Sunovion Pharms Inc |
| — | BLA125685 | Allogenic thymocyte-depleted thymus tissue-agdc | — |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
No recall of these products (by NDC code) appears in the FDA enforcement reports.
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