Quick answers
- What is Buprenorphine Sublingual C-III?
- Buprenorphine Sublingual C-III is a brand name of Buprenorphine, a prescription medicine. The FDA NDC Directory lists 2 Buprenorphine Sublingual C-III products in 2 strengths and forms.
- Who makes Buprenorphine Sublingual C-III?
- Hikma holds the FDA application for Buprenorphine Sublingual C-III (ANDA078633, approved October 8, 2009).
- Is there a generic or store brand of Buprenorphine Sublingual C-III?
- Yes. The FDA NDC Directory lists 47 other products with the same active ingredients, strength and form as a Buprenorphine Sublingual C-III product, 47 of them generic. Ask your pharmacist whether one is right for you.
- Has Buprenorphine Sublingual C-III been recalled?
- No recall linked to Buprenorphine Sublingual C-III products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Buprenorphine Sublingual C-III is
Each Buprenorphine Sublingual C-III 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 2 mg tablet (sublingual) | Buprenorphine Sublingual C-III | 23 products, 17 companies | DailyMed |
| buprenorphine hydrochloride 8 mg tablet (sublingual) | Buprenorphine Sublingual C-III | 24 products, 17 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Buprenorphine →
FDA approval
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| ANDA078633 | Hikma | October 8, 2009 | 2 |
Companies that list Buprenorphine Sublingual C-III
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Buprenorphine Sublingual C-III products.
- Direct_Rx2 products
Recalls
No recall linked to Buprenorphine Sublingual C-III products (by their NDC code or label) 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 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.