NDC Compounded Drug 26436-5615-1 Naltrexone Hydrochloride Dihydrate

Capsule Oral

Table of Contents

    1. Compounded Product Information
    2. NDC Crossover Products Matching Naltrexone Hcl
    3. Frequently Asked Questions

Compounded Drug Product Information

NDC Product Code 26436-5615
NDC Package Code 26436-5615-1
11-Digit NDC Billing Format NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.		 26436561501
Package Description 1 CAPSULE in 1 CAPSULE
Product Type 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.		 Human Compounded Drug
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		 Naltrexone Hcl
Non-Proprietary Name 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.		 Naltrexone Hcl
Substance Name 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.		 Naltrexone Hydrochloride Dihydrate
Usage Information Product Usage Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.		 This medication is used to prevent people who have been addicted to certain drugs (opiates) from taking them again. It is used as part of a complete treatment program for drug abuse (e.g., compliance monitoring, counseling, behavioral contract, lifestyle changes). This medication must not be used in people currently taking opiates, including methadone. Doing so can cause sudden withdrawal symptoms. Naltrexone belongs to a class of drugs known as opiate antagonists. It works in the brain to prevent opiate effects (e.g., feelings of well-being, pain relief). It also decreases the desire to take opiates. This medication is also used to treat alcohol abuse. It can help people drink less alcohol or stop drinking altogether. It also decreases the desire to drink alcohol when used with a treatment program that includes counseling, support, and lifestyle changes.
Dosage Form Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Route Name Oral - Administration to or by way of the mouth.
Marketing Category OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS)
Labeler Code 26436
Labeler Name What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		 Hybrid Pharma
Substance Name Naltrexone Hydrochloride Dihydrate
Active Ingredients Information 3.5 mg
Reporting Period 2024-1

NDC Crossover Products Matching Naltrexone Hydrochloride Dihydrate

NDC crossover of Naltrexone Hcl with NDC 26436-5615 a human compounded drug with other similar products matching the same substance name (Naltrexone Hydrochloride Dihydrate) and the same administration route (oral) or dosage form (capsule).

Frequently Asked Questions

What is the NDC number assigned to Naltrexone Hcl?

Naltrexone Hcl was assigned by its manufacturer with NDC product code 26436-5615. This product is a drug classified as a human compounded drug. Compounded drugs are medications created by combining or altering existing drugs to meet the specific needs of certain patients. The NDC directory only includes information about compounded drugs from facilities that choose to assign NDC numbers to their products.

Which are the NDC package codes for Naltrexone Hcl?

The NDC package code 26436-5615-1 was assigned to a 1 CAPSULE in 1 CAPSULE of naltrexone hydrochloride dihydrate administered oral via capsule.

Who manufactures this product?

Naltrexone Hcl is manufactured by an outsourced facility and labeled by Hybrid Pharma. All compounded drugs included in the NDC directory are classified as "Outsourcing Facility Compounded Human Drug Product (Exempt from Approval Requirements)". Outsourcing facilities are a type of drug compounding facility regulated under Section 503B of the FD&C Act could be eligible for exemptions from drug registration if they meet all the conditions specified under Section 503B.

Which are the NDC crossover matchings for this product?

We found 3 matching products that have the same substance, dosage form and administration route. The matching products are manufactured by Hybrid Pharma with NDC product codes 26436-5610-1, 26436-5611-1 and 26436-5614-1.