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United States · US · US:82686-300_1712a2ca-a737-42ee-b2c1-f8b67ae17272
Miudella
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSebela Women's Health Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1182686300011 TRAY in 1 BOX, UNIT-DOSE (82686-300-01) / 1 INTRAUTERINE DEVICE in 1 TRAY
Annotations
UNII (FDA Substance ID)
789U1901C5
COPPER
RxCUI 2837
Orange Book
N218201
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "789U1901C5",
"rxcui": "2837",
"inchikey": "RYGMFSIKBFXOCR-UHFFFAOYSA-N",
"display_name": "COPPER",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAUTERINE",
"spl_meta": {
"9f5c5008-8166-40fa-9627-e9aa620b547e": {
"match": "brand_token",
"title": "MIUDELLA (COPPER) INTRAUTERINE DEVICE [SEBELA WOMEN'S HEALTH INC.]",
"spl_version": "5",
"published_date": "2026-05-28"
}
},
"productid": "82686-300_1712a2ca-a737-42ee-b2c1-f8b67ae17272",
"productndc": "82686-300",
"dosage_form": "INTRAUTERINE DEVICE",
"orange_book": {
"appl_no": "218201",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "N/A",
"product_no": "001",
"approval_date": "Feb 24, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "COPPER",
"proprietary_name": "Miudella",
"active_ingred_unit": "mm/1",
"application_number": "NDA218201",
"marketing_category": "NDA",
"nonproprietary_name": "Copper",
"start_marketing_date": "20251201",
"active_numerator_strength": "175"
}Access this data programmatically
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