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 ID: 70539-001_1114b8ed-a9d3-40cf-a157-6a3a60065c32
• NDC: 70539-001
• Product Type: Human Prescription Drug
• Proprietary Name: Tymlos
• Generic Name: Abaloparatide
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2017-05-01
• Marketing Category: NDA / NDA
• Application Number: NDA208743
• Labeler Name: Radius Health, Inc.
• Substance Name: ABALOPARATIDE
• Active Ingredient Strength: 2000 ug/mL
• Pharm Classes: Parathyroid Hormone-Related Peptide Analog [EPC], Parathyroid Hormone-Related Protein [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

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 Date: 2017-05-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70539-001-02 [70539000102]

Tymlos INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA208743
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-05-01

NDC 70539-001-99 [70539000199]

Tymlos INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA208743
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-05-01

NDC 70539-001-01 [70539000101]

Tymlos INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA208743
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-05-01

NDC 70539-001-98 [70539000198]

Tymlos INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA208743
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-05-01

Drug Details

Active Ingredients

Ingredient	Strength
ABALOPARATIDE	2000 ug/mL

OpenFDA Data

• SPL SET ID: 712143d9-e21e-4013-bb3b-3426a21060a8
• Manufacturer:
  • Radius Health, Inc.
• UNII:
  • AVK0I6HY2U
• 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: