Contrave
NDC Package 43063-772-70
Package Information
Contrave is a medication used with a doctor-approved exercise, behavior change, and reduced-calorie diet program to help you lose weight. Marketed by Pd-rx Pharmaceuticals, Inc., this product is identified by NDC 43063-772 and is authorized under FDA application NDA200063.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 43063 - Pd-rx Pharmaceuticals, Inc.
- 43063-772 - Contrave
- 43063-772-70 - 70 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
- 43063-772 - Contrave
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 43063-772-70 identifies a specific commercial package of 70 tablet, extended release in 1 bottle, plastic of Contrave Extended-release, labeled by Pd-rx Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 70 billable units per package. This is formulated for use and contains as the active substance.
Is this product currently listed with the FDA?
This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Pd-rx Pharmaceuticals, Inc. on October 22, 2014. The current certification is valid through August 03, 2022.
What are the primary indications for this medication?
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.
How is this Pd-rx Pharmaceuticals, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 43063077270. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 70 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.