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United States · US · US:50090-5422_cb78d0c3-de38-40ed-a74b-8391b860e1cb

Ella

Orange BookUNIISPLATC G03XB02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeG03XB02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009054220
    1 BLISTER PACK in 1 CARTON (50090-5422-0) / 1 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
YF7V70N02B
ULIPRISTAL ACETATE
RxCUI 1005920
Orange Book
N022474
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "YF7V70N02B",
    "rxcui": "1005920",
    "inchikey": "OOLLAFOLCSJHRE-ZHAKMVSLSA-N",
    "display_name": "ULIPRISTAL ACETATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "2bf93d23-cddd-4613-9066-5b5fa090404b": {
      "match": "brand_token",
      "title": "ELLA (ULIPRISTAL ACETATE) TABLET [HRA PHARMA AMERICA, INC.]",
      "spl_version": "6",
      "published_date": "2026-01-08"
    }
  },
  "productid": "50090-5422_cb78d0c3-de38-40ed-a74b-8391b860e1cb",
  "productndc": "50090-5422",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "022474",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "001",
        "approval_date": "Aug 13, 2010"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ULIPRISTAL ACETATE",
  "proprietary_name": "Ella",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022474",
  "marketing_category": "NDA",
  "nonproprietary_name": "ulipristal acetate",
  "start_marketing_date": "20200511",
  "active_numerator_strength": "30"
}

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