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United States · US · US:80584-103_3d594e56-b2b5-8a28-e063-6394a90a20e1
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Orange BookUNIISPLATC G03AD01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerWinx Health Inc.
CountryUS (United States)
ATC codeG03AD01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1180584103011 BLISTER PACK in 1 CARTON (80584-103-01) / 1 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
5W7SIA7YZW
LEVONORGESTREL
RxCUI 6373
Orange Book
A207660
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "5W7SIA7YZW",
"rxcui": "6373",
"inchikey": "WWYNJERNGUHSAO-XUDSTZEESA-N",
"display_name": "LEVONORGESTREL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"0cdf198e-c114-b9fa-e063-6294a90a566a": {
"match": "brand_token",
"title": "RESTART (LEVONORGESTREL) TABLET [WINX HEALTH INC.]",
"spl_version": "6",
"published_date": "2025-08-29"
}
},
"productid": "80584-103_3d594e56-b2b5-8a28-e063-6394a90a20e1",
"productndc": "80584-103",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "207660",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "1.5MG",
"product_no": "001",
"approval_date": "May 2, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "LEVONORGESTREL",
"proprietary_name": "Restart",
"active_ingred_unit": "mg/1",
"application_number": "ANDA207660",
"marketing_category": "ANDA",
"nonproprietary_name": "Levonorgestrel",
"start_marketing_date": "20241008",
"active_numerator_strength": "1.5"
}Related drugs
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