Tymlos Injection, Solution
NDC Package 70539-001-98

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Tymlos (abaloparatide) injection is abaloparatide is used to treat bone loss (osteoporosis) for women after menopause who are at high risk of having broken bones (fractures). This formulation utilizes a injection, solution delivery system. Marketed by Radius Health, Inc., this product is identified by NDC 70539-001 and is authorized under FDA application NDA208743.

Identification & Billing

NDC Package Code
70539-001-98
Package Description
1 CARTRIDGE in 1 BOX, UNIT-DOSE / 1.56 mL in 1 CARTRIDGE (70539-001-99)
Product Code
70539-001
11-Digit Billing Format
70539000198
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tymlos
Non-Proprietary Name
Abaloparatide
Substance Name
Abaloparatide
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
ABALOPARATIDE 3.12 mg/1.56mL
Pharmacologic Class
Usage Information
Abaloparatide is used to treat bone loss (osteoporosis) for women after menopause who are at high risk of having broken bones (fractures). It is similar to a natural hormone in your body (parathyroid hormone). It works by increasing bone density and strength. This effect helps to decrease the risk of having a fracture. This medication should not be used for children or young adults whose bones are still growing.

Regulatory & Marketing

Labeler Name
Radius Health, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA208743
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-01-2017
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
Yes

Hierarchy Structure

Code Lineage

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.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (70539-001). Click a package code to view its specific billing and regulatory data.

70539-001-02
1 CARTRIDGE in 1 BOX, UNIT-DOSE / 1.56 mL in 1 CARTRIDGE (70539-001-01)

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70539-001-98 identifies a specific commercial package of 1 cartridge in 1 box, unit-dose / 1.56 ml in 1 cartridge (70539-001-99) of Tymlos, a human prescription drug labeled by Radius Health, Inc.. This injection, solution is formulated for subcutaneous use and contains abaloparatide as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Radius Health, Inc. on May 01, 2017. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Abaloparatide is used to treat bone loss (osteoporosis) for women after menopause who are at high risk of having broken bones (fractures). It is similar to a natural hormone in your body (parathyroid hormone). It works by increasing bone density and strength. This effect helps to decrease the risk of having a fracture. This medication should not be used for children or young adults whose bones are still growing.

How is this Radius Health, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70539000198. 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:

10-Digit Format (5-3-2)
70539-001-98
11-Digit CMS (5-4-2)
70539-0001-98

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.