Prescription drug · NDA
Belbuca (Buprenorphine hydrochloride) NDC 59385-025
Buprenorphine hydrochloride 600 ug/1 · Film, Soluble · Buccal · BioDelivery Sciences International Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59385-025-60 | 5938500256059385002560 | 60 POUCH in 1 CARTON (59385-025-60) / 1 FILM, SOLUBLE in 1 POUCH (59385-025-01)Marketed from Aug 24, 2017 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Belbuca
- Generic name (nonproprietary)
- buprenorphine hydrochloride
- Active ingredients
- Buprenorphine hydrochloride — 600 ug/1
- Dosage form
- Film, Soluble
- Route
- Buccal
- Labeler
- BioDelivery Sciences International IncNDC labeler code 59385
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 207932
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Partial Opioid Agonists (Mechanism)
- Identifiers
- Product ID 59385-025_16403e7a-5881-43d2-990c-a7d673971c3dSPL ID 16403e7a-5881-43d2-990c-a7d673971c3dSPL set ID bc2b7a3d-72cf-497c-95b0-ba2b71f63c64RxCUI 1716057, 1716063, 1716065, 1716067, 1716069, 1716071, 1716073, 1716075, 1716077, 1716079, 1716081, 1716083, 1716086, 1716090UNII 56W8MW3EN1
- Pharmacologic class
- Partial Opioid Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Buccal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N459385002560followed by a unit qualifier and the quantityPackage 59385-0025-60. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
BELBUCA is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. BELBUCA buccal film contains buprenorphine, a partial opioid agonist. BELBUCA is indicated for the management of severe and persistent pain that requires an opioid analgesic that cannot be adequately treated with alternative options, including immediate-release opioids. ( 1 ) Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including BELBUCA, …
Excerpt only. Read the full label for complete information.
About NDC 59385-025
- What is NDC 59385-025?
- 59385-025 is the product NDC for Belbuca (buprenorphine hydrochloride), Buprenorphine hydrochloride 600 ug/1 film, soluble, listed with the FDA by BioDelivery Sciences International Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Belbuca (Buprenorphine hydrochloride).
- What is the active ingredient?
- Buprenorphine hydrochloride.
- Who is the labeler?
- BioDelivery Sciences International Inc, NDC labeler code 59385. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Belbuca?
- 6 other product NDCs are listed under this name. See all Belbuca NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Belbuca products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Belbucabuprenorphine hydrochloride | Buprenorphine hydrochloride 150 ug/1 | Film, SolubleBuccal | BioDelivery Sciences International Inc | 59385-022 | 59385-0022-60 |
| Belbucabuprenorphine hydrochloride | Buprenorphine hydrochloride 750 ug/1 | Film, SolubleBuccal | BioDelivery Sciences International Inc | 59385-026 | 59385-0026-60 |
| Belbucabuprenorphine hydrochloride | Buprenorphine hydrochloride 75 ug/1 | Film, SolubleBuccal | BioDelivery Sciences International Inc | 59385-021 | 59385-0021-60 |
| Belbucabuprenorphine hydrochloride | Buprenorphine hydrochloride 300 ug/1 | Film, SolubleBuccal | BioDelivery Sciences International Inc | 59385-023 | 59385-0023-60 |
| Belbucabuprenorphine hydrochloride | Buprenorphine hydrochloride 450 ug/1 | Film, SolubleBuccal | BioDelivery Sciences International Inc | 59385-024 | 59385-0024-60 |
| Belbucabuprenorphine hydrochloride | Buprenorphine hydrochloride 900 ug/1 | Film, SolubleBuccal | BioDelivery Sciences International Inc | 59385-027 | 59385-0027-60 |
Other NDCs under NDA 207932
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Belbucabuprenorphine hydrochloride | Buprenorphine hydrochloride 75 ug/1 | Film, SolubleBuccal | BioDelivery Sciences International Inc | 59385-021 |
| Belbucabuprenorphine hydrochloride | Buprenorphine hydrochloride 150 ug/1 | Film, SolubleBuccal | BioDelivery Sciences International Inc | 59385-022 |
| Belbucabuprenorphine hydrochloride | Buprenorphine hydrochloride 300 ug/1 | Film, SolubleBuccal | BioDelivery Sciences International Inc | 59385-023 |
| Belbucabuprenorphine hydrochloride | Buprenorphine hydrochloride 450 ug/1 | Film, SolubleBuccal | BioDelivery Sciences International Inc | 59385-024 |
| Belbucabuprenorphine hydrochloride | Buprenorphine hydrochloride 750 ug/1 | Film, SolubleBuccal | BioDelivery Sciences International Inc | 59385-026 |
| Belbucabuprenorphine hydrochloride | Buprenorphine hydrochloride 900 ug/1 | Film, SolubleBuccal | BioDelivery Sciences International Inc | 59385-027 |