tymlos

Generic: abaloparatide

Labeler: radius health, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tymlos
Generic Name abaloparatide
Labeler radius health, inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

abaloparatide 3.12 mg/1.56mL

Manufacturer
Radius Health, Inc.

Identifiers & Regulatory

Product NDC 70539-001
Product ID 70539-001_72b77fcf-921b-426c-bb17-e1ccf8dc0f6d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208743
Listing Expiration 2026-12-31
Marketing Start 2017-05-01

Pharmacologic Class

Established (EPC)
parathyroid hormone-related peptide analog [epc]
Chemical Structure
parathyroid hormone-related protein [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70539001
Hyphenated Format 70539-001

Supplemental Identifiers

RxCUI
1921075 1921081
UNII
AVK0I6HY2U
NUI
N0000193453 M0150746

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tymlos (source: ndc)
Generic Name abaloparatide (source: ndc)
Application Number NDA208743 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 3.12 mg/1.56mL
source: ndc
Packaging
  • 1 CARTRIDGE in 1 BOX, UNIT-DOSE (70539-001-02) / 1.56 mL in 1 CARTRIDGE (70539-001-01)
  • 1 CARTRIDGE in 1 BOX, UNIT-DOSE (70539-001-98) / 1.56 mL in 1 CARTRIDGE (70539-001-99)
source: ndc

Packages (2)

70539-001-02 1 CARTRIDGE in 1 BOX, UNIT-DOSE (70539-001-02) / 1.56 mL in 1 CARTRIDGE (70539-001-01) 70539-001-98 1 CARTRIDGE in 1 BOX, UNIT-DOSE (70539-001-98) / 1.56 mL in 1 CARTRIDGE (70539-001-99)

Ingredients (1)

abaloparatide (3.12 mg/1.56mL)

Linked Drug Pages (1)

Tymlos ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "72b77fcf-921b-426c-bb17-e1ccf8dc0f6d", "openfda": {"nui": ["N0000193453", "M0150746"], "unii": ["AVK0I6HY2U"], "rxcui": ["1921075", "1921081"], "spl_set_id": ["712143d9-e21e-4013-bb3b-3426a21060a8"], "pharm_class_cs": ["Parathyroid Hormone-Related Protein [CS]"], "pharm_class_epc": ["Parathyroid Hormone-Related Peptide Analog [EPC]"], "manufacturer_name": ["Radius Health, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CARTRIDGE in 1 BOX, UNIT-DOSE (70539-001-02)  / 1.56 mL in 1 CARTRIDGE (70539-001-01)", "package_ndc": "70539-001-02", "marketing_start_date": "20170501"}, {"sample": true, "description": "1 CARTRIDGE in 1 BOX, UNIT-DOSE (70539-001-98)  / 1.56 mL in 1 CARTRIDGE (70539-001-99)", "package_ndc": "70539-001-98", "marketing_start_date": "20170501"}], "brand_name": "Tymlos", "product_id": "70539-001_72b77fcf-921b-426c-bb17-e1ccf8dc0f6d", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Parathyroid Hormone-Related Peptide Analog [EPC]", "Parathyroid Hormone-Related Protein [CS]"], "product_ndc": "70539-001", "generic_name": "abaloparatide", "labeler_name": "Radius Health, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tymlos", "active_ingredients": [{"name": "ABALOPARATIDE", "strength": "3.12 mg/1.56mL"}], "application_number": "NDA208743", "marketing_category": "NDA", "marketing_start_date": "20170501", "listing_expiration_date": "20261231"}