NDC 70539-001

Tymlos

Abaloparatide

Tymlos is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Radius Health, Inc.. The primary component is Abaloparatide.

Product ID70539-001_1114b8ed-a9d3-40cf-a157-6a3a60065c32
NDC70539-001
Product TypeHuman Prescription Drug
Proprietary NameTymlos
Generic NameAbaloparatide
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2017-05-01
Marketing CategoryNDA / NDA
Application NumberNDA208743
Labeler NameRadius Health, Inc.
Substance NameABALOPARATIDE
Active Ingredient Strength2000 ug/mL
Pharm ClassesParathyroid Hormone-Related Peptide Analog [EPC], Parathyroid Hormone-Related Protein [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 70539-001-02

1 CARTRIDGE in 1 BOX, UNIT-DOSE (70539-001-02) > 1.56 mL in 1 CARTRIDGE (70539-001-01)
Marketing Start Date2017-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70539-001-02 [70539000102]

Tymlos INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA208743
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-05-01

NDC 70539-001-99 [70539000199]

Tymlos INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA208743
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-05-01

NDC 70539-001-01 [70539000101]

Tymlos INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA208743
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-05-01

NDC 70539-001-98 [70539000198]

Tymlos INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA208743
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-05-01

Drug Details

Active Ingredients

IngredientStrength
ABALOPARATIDE2000 ug/mL

OpenFDA Data

SPL SET ID:712143d9-e21e-4013-bb3b-3426a21060a8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1921081
  • 1921075
  • PHarm Class EPC
  • Parathyroid Hormone-Related Peptide Analog [EPC]
  • UPC Code
  • 0370539001985
  • 0370539001022
  • NUI Code
  • N0000170963
  • N0000175452
  • N0000193453
  • Pharmacological Class

    • Parathyroid Hormone-Related Peptide Analog [EPC]
    • Parathyroid Hormone-Related Protein [Chemical/Ingredient]
    • Analogs/Derivatives [Chemical/Ingredient]

    Medicade Reported Pricing

    70539000102 TYMLOS 80 MCG DOSE PEN INJECTR

    Pricing Unit: ML | Drug Type:

    70539000101 TYMLOS 80 MCG DOSE PEN INJECTR

    Pricing Unit: ML | Drug Type:

    Trademark Results [Tymlos]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TYMLOS
    TYMLOS
    97851998 not registered Live/Pending
    Radius Health, Inc.
    2023-03-22
    TYMLOS
    TYMLOS
    88640220 not registered Live/Pending
    Radius Health, Inc.
    2019-10-03
    TYMLOS
    TYMLOS
    86983687 5433991 Live/Registered
    Radius Health, Inc.
    2016-03-25
    TYMLOS
    TYMLOS
    86953480 not registered Dead/Abandoned
    Radius Health, Inc.
    2016-03-25

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