Quick answers
- What is Belbuca?
- Belbuca is a brand name of Buprenorphine, a prescription medicine. The FDA NDC Directory lists 7 Belbuca products in 7 strengths and forms.
- Who makes Belbuca?
- Bdsi holds the FDA application for Belbuca (NDA207932, approved October 23, 2015).
- Is there a generic or store brand of Belbuca?
- Other products of Buprenorphine are listed with the FDA, but none in exactly the same strength and form as a Belbuca product.
- What do pharmacies pay for Belbuca?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 7 Belbuca strengths and forms (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 Belbuca been recalled?
- FDA enforcement reports list 2 recalls of Belbuca products; the newest started March 15, 2021. A recall usually concerns specific lots, not every product.
What Belbuca is
Each Belbuca 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.
Buprenorphine · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| buprenorphine hydrochloride 150 ug film, soluble (buccal) | Belbuca | None listed | DailyMed |
| buprenorphine hydrochloride 300 ug film, soluble (buccal) | Belbuca | None listed | DailyMed |
| buprenorphine hydrochloride 450 ug film, soluble (buccal) | Belbuca | None listed | DailyMed |
| buprenorphine hydrochloride 600 ug film, soluble (buccal) | Belbuca | None listed | DailyMed |
| buprenorphine hydrochloride 75 ug film, soluble (buccal) | Belbuca | None listed | DailyMed |
| buprenorphine hydrochloride 750 ug film, soluble (buccal) | Belbuca | None listed | DailyMed |
| buprenorphine hydrochloride 900 ug film, soluble (buccal) | Belbuca | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Buprenorphine →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA207932 | Bdsi | October 23, 2015 | 7 |
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 |
|---|---|---|
| buprenorphine hydrochloride 150 ug film, soluble | Brand: Belbuca | $7.55 per unit |
| buprenorphine hydrochloride 300 ug film, soluble | Brand: Belbuca | $11.86 per unit |
| buprenorphine hydrochloride 450 ug film, soluble | Brand: Belbuca | $16.11 per unit |
| buprenorphine hydrochloride 600 ug film, soluble | Brand: Belbuca | $17.18 per unit |
| buprenorphine hydrochloride 75 ug film, soluble | Brand: Belbuca | $7.54 per unit |
| buprenorphine hydrochloride 750 ug film, soluble | Brand: Belbuca | $18.09 per unit |
| buprenorphine hydrochloride 900 ug film, soluble | Brand: Belbuca | $18.59 per unit |
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 Belbuca
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Belbuca products.
- BioDelivery Sciences International Inc7 products
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.
-
March 15, 2021 · Class II · Terminated · D-0448-2021
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. — Cardinal Health Inc.
-
March 15, 2021 · Class II · Terminated · D-0449-2021
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 — Cardinal Health Inc.
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.