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United States · US · US:72189-215_4d3a9c67-ae9a-d4c1-e063-6394a90aff1f

Junel FE

In shortageOrange BookUNIISPLATC G03CA

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

Identification

ManufacturerDirect_Rx
CountryUS (United States)
ATC codeG03CA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7218921528
    28 TABLET in 1 POUCH (72189-215-28)

Annotations

UNII (FDA Substance ID)
423D2T571U
ETHINYL ESTRADIOL
RxCUI 4124
Orange Book
A076380
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Ethinyl Estradiol; Etonogestrel Ring
Raw payload (JSON)
{
  "unii": {
    "unii": "423D2T571U",
    "rxcui": "4124",
    "inchikey": "BFPYWIDHMRZLRN-SLHNCBLASA-N",
    "display_name": "ETHINYL ESTRADIOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "93a2f8c9-3550-42ec-8f76-3ac9badf4bb2": {
      "match": "brand_token",
      "title": "JUNEL FE 28 DAY (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [PD-RX PHARMACEUTICALS, INC.]",
      "spl_version": "18",
      "published_date": "2026-05-25"
    }
  },
  "productid": "72189-215_4d3a9c67-ae9a-d4c1-e063-6394a90aff1f",
  "productndc": "72189-215",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076380",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.02MG;1MG",
        "product_no": "001",
        "approval_date": "May 30, 2003"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ETHINYL ESTRADIOL; NORETHINDRONE ACETATE",
  "shortage_reason": "Ethinyl Estradiol; Etonogestrel Ring",
  "shortage_status": "current",
  "proprietary_name": "Junel FE",
  "active_ingred_unit": "ug/1; mg/1",
  "application_number": "ANDA076380",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Junel FE",
  "start_marketing_date": "20211006",
  "active_numerator_strength": "20; 1"
}

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