Contrave Tablet, Extended Release
NDC 51267-890

View dosage, usage, ingredients, routes, and UNII mappings.
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

Contrave (naltrexone hydrochloride and bupropion hydrochloride) is a NDA-approved product labeled by Nalpropion Pharmaceuticals Llc. This medication is used with a doctor-approved exercise, behavior change, and reduced-calorie diet program to help you lose weight. It is supplied as a blue tablet, extended release for oral administration. This product entry covers the primary NDC 51267-890 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

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
Code Navigator:

Clinical Specifications

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 & Regulatory Data

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.

Marketing Timeline

Start Marketing Date: [9]
10-22-2014
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

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. It is commonly known by its generic name, naltrexone hydrochloride and bupropion hydrochloride. This pharmaceutical product is labeled by Nalpropion Pharmaceuticals Llc and is currently categorized as listed product. The medication is a tablet, extended release administered via oral route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 51267-890-07, 51267-890-99. 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 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 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.
  • 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 the associated UNII Codes?

The UNII codes for the active 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: 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 of this product?

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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]


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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 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".