NDC Compounded Drug 70168-0031-1 Testosterone

Pellet Subcutaneous

Table of Contents

    1. Compounded Product Information
    2. NDC Crossover Products Matching Testo37.5mgchol
    3. Frequently Asked Questions

Compounded Drug Product Information

NDC Product Code 70168-0031
NDC Package Code 70168-0031-1
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.		 70168003101
Package Description 1 PELLET in 1 VIAL, SINGLE-USE
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.		 Testo37.5mgchol
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.		 Testosterone
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.		 Testosterone
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 medicated patch contains testosterone. It is used for hormone replacement in men who are not able to produce enough testosterone (for example, due to hypogonadism). This medication is absorbed through the skin, enters your bloodstream, and helps your body reach normal testosterone levels. Testosterone helps the body to develop and maintain the male sexual characteristics (masculinity), such as a deep voice and body hair. It also helps to maintain muscle and prevent bone loss, and is necessary for natural sexual ability/desire. This drug should not be used by women.
Dosage Form Pellet - A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding.
Route Name Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Marketing Category OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS)
Labeler Code 70168
Labeler Name What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		 Bso, Llc
Substance Name Testosterone
Active Ingredients Information 37.5 mg
DEA Schedule What is the Drug Enforcement Administration (DEA) CIII Schedule?
The controlled substances in the CIII schedule have an abuse potential and dependence liability less than those in schedules CI and CII, and have an accepted medical use in the United States. Schedule CIII controlled substances include preparations containing limited quantities of certain narcotic drugs, and other nonnarcotic drugs such as: derivatives of barbituric acid, except those that are listed in another schedule, glutethimide (Doriden), methyprylon (Noludar), nalorphine, benzphetamine, chlorphentermine, clortermine, and phendimetrazine.		 Schedule III (CIII) Substances
Reporting Period 2023-2

NDC Crossover Products Matching Testosterone

NDC crossover of Testo37.5mgchol with NDC 70168-0031 a human compounded drug with other similar products matching the same substance name (Testosterone) and the same administration route (subcutaneous) or dosage form (pellet).

Frequently Asked Questions

What is the NDC number assigned to Testo62.5mgchol?

Testo62.5mgchol was assigned by its manufacturer with NDC product code 70168-0031. 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 Testo62.5mgchol?

The NDC package code 70168-0031-1 was assigned to a 1 PELLET in 1 VIAL, SINGLE-USE of testosterone administered subcutaneous via pellet.

Who manufactures this product?

Testo62.5mgchol is manufactured by an outsourced facility and labeled by Bso, Llc. 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 30 matching products that have the same substance, dosage form and administration route. The matching products are manufactured by BSO, LLC with NDC product codes 70168-0010-1, 70168-0010-1, 70168-0010-1, 70168-0010-1, 70168-0011-1, 70168-0011-1, 70168-0011-1, 70168-0011-1, 70168-0020-1, 70168-0020-1, 70168-0020-1, 70168-0020-1, 70168-0021-1, 70168-0021-1, 70168-0021-1, 70168-0021-1, 70168-0030-1, 70168-0030-1, 70168-0030-1, 70168-0030-1, 70168-0040-1, 70168-0040-1, 70168-0040-1, 70168-0040-1, 70168-0041-1, 70168-0041-1, 70168-0041-1, 70168-0041-1, 70168-0051-1 and 70168-0051-1.