BioDelivery Sciences International Inc
NDC labeler code: 59385
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
- BuprenorphineBelbuca, Brixadi, Buprenorphine Transdermal System · 7 products
- NaldemedineSymproic · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| March 23, 2017 | NDA208854 | Naldemedine SYMPROIC | Bdsi |
| October 23, 2015 | NDA207932 | Buprenorphine BELBUCA | Bdsi |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2021
-
March 15, 2021 · Class II · Terminated · D-0448-2021 · Buprenorphine
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Belbuca (buprenorphine hydrochloride) buccal film 300 mcg 60 pouches containing 1 buccal film each Rx only NDC 59385-023-60 Manufactured for: BioDelivery Sciences International, Inc. Raleigh, NC 27612.
-
March 15, 2021 · Class II · Terminated · D-0450-2021 · Naldemedine
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
SYMPROIC (NAIDEMEDINE) TABLETS 0.2MG 30 TABLETS; NDC 59385-041-30; RX; TABLETS
-
March 15, 2021 · Class II · Terminated · D-0449-2021 · Buprenorphine
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Belbuca (buprenorphine hydrochloride) buccal film 600 mcg 60 pouches containing 1 buccal film each Rx only NDC 59385-025-60 Manufactured for: BioDelivery Sciences International, Inc. Raleigh, NC 27612 USA
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