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United States · US · US:50090-5959_74985d3b-59fe-491b-bf40-962faa0274ab

Etonogestrel/Ethinyl Estradiol

In shortageOrange BookUNIISPLATC G03CA

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeG03CA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009059590
    1 POUCH in 1 BOX (50090-5959-0) / 1 d in 1 POUCH

Annotations

UNII (FDA Substance ID)
423D2T571U
ETHINYL ESTRADIOL
RxCUI 4124
Orange Book
N021187
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Ethinyl Estradiol; Ethinyl Diacetate Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "423D2T571U",
    "rxcui": "4124",
    "inchikey": "BFPYWIDHMRZLRN-SLHNCBLASA-N",
    "display_name": "ETHINYL ESTRADIOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "VAGINAL",
  "spl_meta": {
    "f0d80e01-f4f5-4b1a-bc9e-50a2bd4390b1": {
      "match": "brand_token",
      "title": "ETONOGESTREL/ETHINYL ESTRADIOL (ETONOGESTREL AND ETHINYL ESTRADIOL) INSERT, EXTENDED RELEASE [PRASCO LABORATORIES]",
      "spl_version": "18",
      "published_date": "2025-02-28"
    }
  },
  "productid": "50090-5959_74985d3b-59fe-491b-bf40-962faa0274ab",
  "productndc": "50090-5959",
  "dosage_form": "INSERT, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "021187",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.015MG/24HR;0.12MG/24HR",
        "product_no": "001",
        "approval_date": "Oct 3, 2001"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ETHINYL ESTRADIOL; ETONOGESTREL",
  "shortage_reason": "Ethinyl Estradiol; Ethinyl Diacetate Tablet",
  "shortage_status": "current",
  "proprietary_name": "Etonogestrel/Ethinyl Estradiol",
  "active_ingred_unit": "mg/d; mg/d",
  "application_number": "NDA021187",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "etonogestrel and ethinyl estradiol",
  "start_marketing_date": "20210601",
  "active_numerator_strength": ".015; .12"
}

Related drugs

Other records sharing ATC code G03CA.

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