Back to search
🇺🇸

United States · US · US:70539-001_72b77fcf-921b-426c-bb17-e1ccf8dc0f6d

Tymlos

Orange BookUNIISPLATC H05AA04

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerRadius Health, Inc.
CountryUS (United States)
ATC codeH05AA04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7053900102
    1 CARTRIDGE in 1 BOX, UNIT-DOSE (70539-001-02) / 1.56 mL in 1 CARTRIDGE (70539-001-01)
  • ndc11
    7053900198
    1 CARTRIDGE in 1 BOX, UNIT-DOSE (70539-001-98) / 1.56 mL in 1 CARTRIDGE (70539-001-99)

Annotations

UNII (FDA Substance ID)
AVK0I6HY2U
ABALOPARATIDE
RxCUI 1921069
Orange Book
N208743
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "AVK0I6HY2U",
    "rxcui": "1921069",
    "inchikey": null,
    "display_name": "ABALOPARATIDE",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "712143d9-e21e-4013-bb3b-3426a21060a8": {
      "match": "brand_token",
      "title": "TYMLOS (ABALOPARATIDE) INJECTION, SOLUTION [RADIUS HEALTH, INC.]",
      "spl_version": "18",
      "published_date": "2025-04-11"
    }
  },
  "productid": "70539-001_72b77fcf-921b-426c-bb17-e1ccf8dc0f6d",
  "productndc": "70539-001",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "208743",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "3.12MG/1.56ML (2MG/ML)",
        "product_no": "001",
        "approval_date": "Apr 28, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ABALOPARATIDE",
  "proprietary_name": "Tymlos",
  "active_ingred_unit": "mg/1.56mL",
  "application_number": "NDA208743",
  "marketing_category": "NDA",
  "nonproprietary_name": "abaloparatide",
  "start_marketing_date": "20170501",
  "active_numerator_strength": "3.12"
}

Related drugs

Other records sharing ATC code H05AA04.

Access this data programmatically

Query Tymlos and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.