Belbuca Film, Soluble
NDC 59385-027

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 59385-027?
  5. Belbuca Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

Belbuca (buprenorphine hydrochloride) is a NDA-approved product labeled by Biodelivery Sciences International Inc. Buprenorphine is used to help relieve severe ongoing pain. It is supplied as a yellow film, soluble for buccal administration. This product entry covers the primary NDC 59385-027 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
59385-027
Proprietary Name:
Belbuca
Non-Proprietary Name: [1]
Buprenorphine Hydrochloride
Substance Name: [2]
Buprenorphine Hydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Film, Soluble - A thin layer or coating which is susceptible to being dissolved when in contact with a liquid.
Administration Route(s): [4]
Buccal - Administration directed toward the cheek, generally from within the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Biodelivery Sciences International Inc
Labeler Code:
59385
Product Label ID:
bc2b7a3d-72cf-497c-95b0-ba2b71f63c64
FDA Application Number: [6]
NDA207932
DEA Schedule: [7]
Schedule III (CIII) Substances
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
08-11-2017
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Product Characteristics

Color(s):
YELLOW (C48330)
Shape:
RECTANGLE (C48347)
Size(s):
12 MM
24 MM
9 MM
14 MM
19 MM
23 MM
28 MM
Imprint(s):
E0
E1
E3
E4
E6
E7
E9
Score:
1
Flavor(s):

Code Structure Chart

Product Details

What is NDC 59385-027?

The NDC code 59385-027 is assigned by the FDA to the product Belbuca. It is commonly known by its generic name, buprenorphine hydrochloride. This pharmaceutical product is labeled by Biodelivery Sciences International Inc and is currently categorized as listed product. The medication is a film, soluble administered via buccal route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 59385-027-60. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Buprenorphine is used to help relieve severe ongoing pain. Buprenorphine belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain. Do not use this medication to relieve pain that is mild or that will go away in a few days. This medication is not for occasional ("as needed") use.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • BUPRENORPHINE HYDROCHLORIDE 900 ug/1 - A derivative of the opioid alkaloid THEBAINE that is a more potent and longer lasting analgesic than MORPHINE. It appears to act as a partial agonist at mu and kappa opioid receptors and as an antagonist at delta receptors. The lack of delta-agonist activity has been suggested to account for the observation that buprenorphine tolerance may not develop with chronic use.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the full disclaimer at the bottom of this page.

Patient Education

Buprenorphine Buccal (chronic pain)


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.
[Learn More]


Buprenorphine Sublingual and Buccal (opioid dependence)


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.
[Learn More]


* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the DEA Schedule? This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".