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NDC 59385-0023-60 BELBUCA 300 ug/1 Details
BELBUCA 300 ug/1
BELBUCA is a BUCCAL FILM, SOLUBLE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by BioDelivery Sciences International Inc. The primary component is BUPRENORPHINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Buprenorphine (Belbuca) is used to relieve severe pain in people who are expected to need pain medication around the clock for a long time and who cannot be treated with other medications. Buprenorphine (Belbuca) should not be used to treat pain that can be controlled by medication that is taken as needed. Buprenorphine (Belbuca) in a class of medications called opiate partial agonists. It works by changing the way the brain and nervous system respond to pain.
Related Packages: 59385-0023-60Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Buprenorphine Buccal (chronic pain)
Buprenorphine and the combination of buprenorphine and naloxone are used to treat opioid dependence (addiction to opioid drugs, including heroin and narcotic painkillers). Buprenorphine is in a class of medications called opioid partial agonist-antagonists and naloxone is in a class of medications called opioid antagonists. Buprenorphine alone and the combination of buprenorphine and naloxone work to prevent withdrawal symptoms when someone stops taking opioid drugs by producing similar effects to these drugs.
Related Packages: 59385-0023-60Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Buprenorphine Sublingual and Buccal (opioid dependence)
Product Information
| NDC | 59385-0023 |
|---|---|
| Product ID | 59385-023_d8541d8a-992a-4b62-8518-ecd85f480e67 |
| Associated GPIs | 65200010108230 |
| GCN Sequence Number | 075052 |
| GCN Sequence Number Description | buprenorphine HCl FILM 300 MCG BUCCAL |
| HIC3 | H3A |
| HIC3 Description | OPIOID ANALGESICS |
| GCN | 39966 |
| HICL Sequence Number | 001762 |
| HICL Sequence Number Description | BUPRENORPHINE HCL |
| Brand/Generic | Brand |
| Proprietary Name | BELBUCA |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | buprenorphine hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | FILM, SOLUBLE |
| Route | BUCCAL |
| Active Ingredient Strength | 300 |
| Active Ingredient Units | ug/1 |
| Substance Name | BUPRENORPHINE HYDROCHLORIDE |
| Labeler Name | BioDelivery Sciences International Inc |
| Pharmaceutical Class | Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA] |
| DEA Schedule | CIII |
| Marketing Category | NDA |
| Application Number | NDA207932 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 59385-0023-60 (59385002360)
| NDC Package Code | 59385-023-60 |
|---|---|
| Billing NDC | 59385002360 |
| Package | 60 POUCH in 1 CARTON (59385-023-60) / 1 FILM, SOLUBLE in 1 POUCH (59385-023-01) |
| Marketing Start Date | 2017-09-01 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 10.7441 |
| Pricing Unit | EA |
| Effective Date | 2024-01-01 |
| NDC Description | BELBUCA 300 MCG FILM |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4 |
| Classification for Rate Setting | B |
| As of Date | 2024-02-21 |