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NDC 70539-001 Tymlos

Abaloparatide Injection, Solution Subcutaneous - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 70539-001?
  4. Tymlos Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes
  10. Patient Education

Product Information

NDC Product Code:
70539-001
Proprietary Name:
Tymlos
Non-Proprietary Name: [1]
Abaloparatide
Substance Name: [2]
Abaloparatide
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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(s): [4]
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Labeler Name: [5]
    Radius Health, Inc.
    Labeler Code:
    70539
    Product Label ID:
    712143d9-e21e-4013-bb3b-3426a21060a8
    FDA Application Number: [6]
    NDA208743
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    05-01-2017
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
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    Product Details

    What is NDC 70539-001?

    The NDC code 70539-001 is assigned by the FDA to the product Tymlos which is a human prescription drug product labeled by Radius Health, Inc.. The generic name of Tymlos is abaloparatide. The product's dosage form is injection, solution and is administered via subcutaneous form. The product is distributed in 2 packages with assigned NDC codes 70539-001-02 1 cartridge in 1 box, unit-dose / 1.56 ml in 1 cartridge (70539-001-01), 70539-001-98 1 cartridge in 1 box, unit-dose / 1.56 ml in 1 cartridge (70539-001-99). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Tymlos?

    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.

    What are Tymlos Active Ingredients?

    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.

    Which are Tymlos UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Tymlos Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Tymlos?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

    Which are the Pharmacologic Classes for Tymlos?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Abaloparatide Injection


    Abaloparatide injection is used to treat osteoporosis (condition in which the bones become thin and weak and break easily) in women who have undergone menopause ('change in life,' end of menstrual periods), who are at high risk of fractures (broken bones) (history of fracture from osteoporosis or multiple risk factors for fracture) or who have failed or not tolerated other medications. Abaloparatide injection is also used to treat osteoporosis in men who are at high risk of fracture or who have failed or not tolerated other medications. Abaloparatide injection contains a synthetic form of a natural human hormone called parathyroid hormone (PTH). It works by causing the body to build new bone and by increasing bone strength and density (thickness).
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] 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.

    [2] 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".