Zubsolv Tablet, Orally Disintegrating
NDC 54123-929

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 54123-929?
  5. Zubsolv 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

Zubsolv (buprenorphine hydrochloride and naloxone hydrochloride) is a NDA-approved product labeled by Orexo Us, Inc.. This medication contains 2 medicines: buprenorphine and naloxone. It is supplied as a white tablet, orally disintegrating for sublingual administration. This product entry covers the primary NDC 54123-929 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
54123-929
Proprietary Name:
Zubsolv
Non-Proprietary Name: [1]
Buprenorphine Hydrochloride And Naloxone Hydrochloride
Substance Name: [2]
Buprenorphine Hydrochloride; Naloxone Hydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Tablet, Orally Disintegrating - A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.
Administration Route(s): [4]
Sublingual - Administration beneath the tongue.

Labeler & Regulatory Data

Labeler Name: [5]
Orexo Us, Inc.
Labeler Code:
54123
Product Label ID:
5f5cfcfe-d52b-49e6-8fe4-550477332dd2
FDA Application Number: [6]
NDA204242
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]
07-04-2013
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
TRIANGLE (C48353)
ROUND (C48348)
DIAMOND (C48338)
OVAL (C48345)
SEMI-CIRCLE (C48349)
Size(s):
7 MM
6 MM
Imprint(s):
1;4
5;7
8;6
11;4
2;9
Score:
1
Flavor(s):

Code Structure Chart

Product Details

What is NDC 54123-929?

The NDC code 54123-929 is assigned by the FDA to the product Zubsolv. It is commonly known by its generic name, buprenorphine hydrochloride and naloxone hydrochloride. This pharmaceutical product is labeled by Orexo Us, Inc. and is currently categorized as listed product. The medication is a tablet, orally disintegrating administered via sublingual route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 54123-929-30. 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?

This medication contains 2 medicines: buprenorphine and naloxone. It is used to treat opioid dependence/addiction. Buprenorphine belongs to a class of drugs called mixed opioid agonist-antagonists. Buprenorphine helps prevent withdrawal symptoms caused by stopping other opioids. Naloxone is an opioid antagonist that blocks the effect of opioids and can cause severe opioid withdrawal when injected. It has little effect when taken by mouth or dissolved under the tongue. It is combined with buprenorphine to prevent abuse and misuse (injection) of this medication. This combination medication is used as part of a complete treatment program for drug abuse (such as compliance monitoring, counseling, behavioral contract, lifestyle changes).

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 2.9 mg/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.
  • NALOXONE HYDROCHLORIDE .71 mg/1 - A specific opiate antagonist that has no agonist activity. It is a competitive antagonist at mu, delta, and kappa opioid receptors.

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:
  • RxCUI: 1431076 - buprenorphine 1.4 MG / naloxone 0.36 MG Sublingual Tablet
  • RxCUI: 1431076 - buprenorphine (as buprenorphine hydrochloride) 1.4 MG / naloxone (as naloxone hydrochloride dihydrate) 0.36 MG Sublingual Tablet
  • RxCUI: 1431083 - zubsolv 1.4 MG / 0.36 MG Sublingual Tablet
  • RxCUI: 1431083 - buprenorphine 1.4 MG / naloxone 0.36 MG Sublingual Tablet [Zubsolv]
  • RxCUI: 1431083 - Zubsolv 1.4/0.36 (buprenorphine HCl / naloxone HCl dihydrate) Sublingual Tablet

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.

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Patient Education

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]


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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".