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United States · US · US:71860-103_3f909bfc-3281-a444-e063-6294a90a221f
DAWNZERA
Orange BookUNIISPLATC B06AC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerIonis Pharmaceuticals Inc.
CountryUS (United States)
ATC codeB06AC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1171860103011 SYRINGE, GLASS in 1 CARTON (71860-103-01) / .8 mL in 1 SYRINGE, GLASS
Annotations
UNII (FDA Substance ID)
Y30VEG5PH1
DONIDALORSEN SODIUM
Orange Book
N219407
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "Y30VEG5PH1",
"rxcui": null,
"inchikey": null,
"display_name": "DONIDALORSEN SODIUM",
"substance_type": "nucleicAcid",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "SUBCUTANEOUS",
"spl_meta": {
"3ff501e0-f75f-07da-e063-6294a90a0cb7": {
"match": "brand_token",
"title": "DAWNZERA (DONIDALORSEN) INJECTION, SOLUTION [IONIS PHARMACEUTICALS INC.]",
"spl_version": "1",
"published_date": "2025-10-01"
}
},
"productid": "71860-103_3f909bfc-3281-a444-e063-6294a90a221f",
"productndc": "71860-103",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "219407",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)",
"product_no": "001",
"approval_date": "Aug 21, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DONIDALORSEN SODIUM",
"proprietary_name": "DAWNZERA",
"active_ingred_unit": "mg/.8mL",
"application_number": "NDA219407",
"marketing_category": "NDA",
"nonproprietary_name": "donidalorsen",
"start_marketing_date": "20250821",
"active_numerator_strength": "80"
}Related drugs
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