🇺🇸
United States · US · US:50102-211_d56023fd-6224-4727-bf3e-e5827dfe5f0a
EContra One-Step
Orange BookUNIISPLATC G03AD01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAfaxys Pharma, LLC
CountryUS (United States)
ATC codeG03AD01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1150102211133 CARTON in 1 PACKAGE (50102-211-13) / 1 BLISTER PACK in 1 CARTON (50102-211-11) / 1 TABLET in 1 BLISTER PACK (50102-211-01)
Annotations
UNII (FDA Substance ID)
5W7SIA7YZW
LEVONORGESTREL
RxCUI 6373
Orange Book
A206867
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": {
"94b23c49-dfba-4a70-ada5-e5c212e703c5": {
"match": "brand_token",
"title": "ECONTRA ONE-STEP (LEVONORGESTREL) TABLET [AFAXYS PHARMA, LLC]",
"spl_version": "11",
"published_date": "2025-04-10"
}
},
"productid": "50102-211_d56023fd-6224-4727-bf3e-e5827dfe5f0a",
"productndc": "50102-211",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "206867",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "1.5MG",
"product_no": "001",
"approval_date": "Dec 8, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "LEVONORGESTREL",
"proprietary_name": "EContra One-Step",
"active_ingred_unit": "mg/1",
"application_number": "ANDA206867",
"marketing_category": "ANDA",
"nonproprietary_name": "Levonorgestrel",
"start_marketing_date": "20180208",
"active_numerator_strength": "1.5"
}Related drugs
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