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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
- ndc1170539001021 CARTRIDGE in 1 BOX, UNIT-DOSE (70539-001-02) / 1.56 mL in 1 CARTRIDGE (70539-001-01)
- ndc1170539001981 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
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