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NDC 51267-890 Contrave Extended-release

Naltrexone Hydrochloride And Bupropion Hydrochloride Tablet, Extended Release Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 51267-890?
  5. Contrave Extended-release Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes
  10. Patient Education

Product Information

Get all the details for National Drug Code (NDC) 51267-890 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
51267-890
Proprietary Name:
Contrave Extended-release
Non-Proprietary Name: [1]
Naltrexone Hydrochloride And Bupropion Hydrochloride
Substance Name: [2]
Bupropion Hydrochloride; Naltrexone Hydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.
Labeler Name: [5]
Nalpropion Pharmaceuticals Llc
Labeler Code:
51267
Product Label ID:
485ff360-32c8-11df-928b-0002a5d5c51b
FDA Application Number: [6]
NDA200063
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
10-22-2014
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Code Navigator:

Product Characteristics

Color(s):
BLUE (C48333)
Shape:
ROUND (C48348)
Size(s):
12 MM
Imprint(s):
NB;890
Score:
1

Code Structure Chart

Product Details

What is NDC 51267-890?

The NDC code 51267-890 is assigned by the FDA to the product Contrave Extended-release which is a human prescription drug product labeled by Nalpropion Pharmaceuticals Llc. The generic name of Contrave Extended-release is naltrexone hydrochloride and bupropion hydrochloride. The product's dosage form is tablet, extended release and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 51267-890-07 7 tablet, extended release in 1 bottle , 51267-890-99 120 tablet, extended release in 1 bottle . 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 Contrave Extended-release?

This medication is used with a doctor-approved exercise, behavior change, and reduced-calorie diet program to help you lose weight. It is used by certain overweight people, such as those who are obese or have weight-related medical problems. Losing weight and keeping it off can lessen the many health risks that come with obesity, including heart disease, diabetes, high blood pressure, and a shorter life. Naltrexone belongs to a class of drugs known as opiate antagonists, and bupropion is an antidepressant that may help restore the balance of certain natural chemicals (neurotransmitters) in your brain. These two medications work together on separate parts of the brain to reduce appetite and how much you eat. Most opiates should not be used for 7 to 10 days before starting naltrexone, but some opiate drugs (such as methadone) should not be used for 10 to 14 days before starting naltrexone. Ask your doctor or pharmacist for more details. Other forms of naltrexone or bupropion are used to treat a variety of conditions including depression, other mental/mood disorders, smoking cessation, addiction to opioid medication, and alcohol abuse. This combination product is not approved for these other uses. Discuss the risks and benefits of this medication, as well as other ways to lose weight, with your doctor.

What are Contrave Extended-release Active Ingredients?

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.
  • BUPROPION HYDROCHLORIDE 90 mg/1 - A propiophenone-derived antidepressant and antismoking agent that inhibits the uptake of DOPAMINE.
  • NALTREXONE HYDROCHLORIDE 8 mg/1 - Derivative of noroxymorphone that is the N-cyclopropylmethyl congener of NALOXONE. It is a narcotic antagonist that is effective orally, longer lasting and more potent than naloxone, and has been proposed for the treatment of heroin addiction. The FDA has approved naltrexone for the treatment of alcohol dependence.

Which are Contrave Extended-release UNII Codes?

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

What is the NDC to RxNorm Crosswalk for Contrave Extended-release?

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: 1551468 - naltrexone HCl 8 MG / buPROPion HCl 90 MG 12HR Extended Release Oral Tablet
  • RxCUI: 1551468 - 12 HR bupropion hydrochloride 90 MG / naltrexone hydrochloride 8 MG Extended Release Oral Tablet
  • RxCUI: 1551474 - Contrave 8 MG / 90 MG 12HR Extended Release Oral Tablet
  • RxCUI: 1551474 - 12 HR bupropion hydrochloride 90 MG / naltrexone hydrochloride 8 MG Extended Release Oral Tablet [Contrave]
  • RxCUI: 1551474 - Contrave (bupropion hydrochloride 90 MG / naltrexone hydrochloride 8 MG) 12 HR Extended Release Oral Tablet

Which are the Pharmacologic Classes for Contrave Extended-release?

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Patient Education

Naltrexone and Bupropion


The combination of naltrexone and bupropion is used along with a reduced calorie diet and exercise plan to help adults who are obese, or who are overweight and have weight-related medical problems, to lose weight and then to keep from gaining back that weight. Naltrexone is in a class of medications called opiate antagonists. Bupropion is in a class of medications called antidepressants. These medications work together on two areas of the brain, the hunger center and the reward system, to reduce appetite and help control cravings.
[Learn More]


* Please review the disclaimer below.

Product Footnotes

[1] 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.

[2] 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.

[3] 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.

[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

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

[6] 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.

[8] 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.

[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, 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".