NDC 55700-867 Belbuca

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
55700-867
Proprietary Name:
Belbuca
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Quality Care Products, Llc
Labeler Code:
55700
Start Marketing Date: [9]
06-02-2020
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
YELLOW (C48330)
Shape:
RECTANGLE (C48347)
Size(s):
14 MM
Imprint(s):
E4
Score:
1
Flavor(s):
PEPPERMINT (C73408)

Product Packages

NDC Code 55700-867-60

Package Description: 60 POUCH in 1 BOX / 1 FILM, SOLUBLE in 1 POUCH

Product Details

What is NDC 55700-867?

The NDC code 55700-867 is assigned by the FDA to the product Belbuca which is product labeled by Quality Care Products, Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 55700-867-60 60 pouch in 1 box / 1 film, soluble in 1 pouch. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Belbuca?

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.

Which are Belbuca UNII Codes?

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

Which are Belbuca Inactive Ingredients 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 Belbuca?

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:

* Please review the disclaimer below.

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 disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] 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.

[12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".