NDC Compounded Drug 71300-6610-9 Naltrexone Hydrochloride

Capsule Oral

Table of Contents

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

Compounded Drug Product Information

NDC Product Code 71300-6610
NDC Package Code 71300-6610-9
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.		 71300661009
Package Description 90 CAPSULE in 1 BOTTLE
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 Hydrochloride
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 Hydrochloride
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
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 71300
Labeler Name What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		 Nubratori Inc.
Substance Name Naltrexone Hydrochloride
Active Ingredients Information 4.5 mg
Reporting Period 2023-2

NDC Crossover Products Matching Naltrexone Hydrochloride

NDC crossover of Naltrexone Hydrochloride with NDC 71300-6610 a human compounded drug with other similar products matching the same substance name (Naltrexone Hydrochloride) and the same administration route (oral) or dosage form (capsule).

Frequently Asked Questions

What is the NDC number assigned to Naltrexone Hydrochloride?

Naltrexone Hydrochloride was assigned by its manufacturer with NDC product code 71300-6610. 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 Hydrochloride?

The NDC package code 71300-6610-9 was assigned to a 90 CAPSULE in 1 BOTTLE of naltrexone hydrochloride administered oral via capsule.

Who manufactures this product?

Naltrexone Hydrochloride is manufactured by an outsourced facility and labeled by Nubratori Inc.. 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 15 matching products that have the same substance, dosage form and administration route. The matching products are manufactured by Nubratori Inc. and Nubratori, Inc with NDC product codes 71300-6600-3, 71300-6600-3, 71300-6600-9, 71300-6600-9, 71300-6610-3, 71300-6610-3, 71300-6646-3, 71300-6646-3, 71300-6646-9, 71300-6646-9, 71300-6647-3, 71300-6647-3, 71300-6647-9, 71300-6647-9 and 71300-6647-9.