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United States · US · US:0310-9420_cea076d0-c827-4c46-9b36-418bf63d5a9d
WAINUA
Orange BookUNIISPLATC N07XX21
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAstraZeneca Pharmaceuticals LP
CountryUS (United States)
ATC codeN07XX21
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1103109420011 SYRINGE, GLASS in 1 CARTON (0310-9420-01) / .8 mL in 1 SYRINGE, GLASS
Annotations
UNII (FDA Substance ID)
0GRZ0F5XJ6
EPLONTERSEN
Orange Book
N217388
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "0GRZ0F5XJ6",
"rxcui": null,
"inchikey": null,
"display_name": "EPLONTERSEN",
"substance_type": "nucleicAcid",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "SUBCUTANEOUS",
"spl_meta": {
"d7dcb847-71dd-4fff-82d0-d43a465fc096": {
"match": "brand_token",
"title": "WAINUA (EPLONTERSEN) INJECTION, SOLUTION [ASTRAZENECA PHARMACEUTICALS LP]",
"spl_version": "20",
"published_date": "2026-04-30"
}
},
"productid": "0310-9420_cea076d0-c827-4c46-9b36-418bf63d5a9d",
"productndc": "0310-9420",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "217388",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML)",
"product_no": "001",
"approval_date": "Dec 21, 2023"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML)",
"product_no": "002",
"approval_date": "Apr 15, 2026"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "EPLONTERSEN",
"proprietary_name": "WAINUA",
"active_ingred_unit": "mg/.8mL",
"application_number": "NDA217388",
"marketing_category": "NDA",
"nonproprietary_name": "EPLONTERSEN",
"start_marketing_date": "20260430",
"active_numerator_strength": "45"
}Related drugs
Other records sharing ATC code N07XX21.
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