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United States · US · US:65162-469_f4ebff86-0b26-41a2-9b3f-6bb4dabbe385

EluRyng

In shortageOrange BookUNIISPLATC G03CA

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

Identification

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

Packs · 1

  • ndc11
    6516246935
    3 POUCH in 1 CARTON (65162-469-35) / 21 d in 1 POUCH (65162-469-32)

Annotations

UNII (FDA Substance ID)
423D2T571U
ETHINYL ESTRADIOL
RxCUI 4124
Orange Book
A210830
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": {
    "c6c8512d-b258-4be5-8c2f-0f1893f198b9": {
      "match": "brand_token",
      "title": "ELURYNG (ETONOGESTREL AND ETHINYL ESTRADIOL) RING [AMNEAL PHARMACEUTICALS LLC]",
      "spl_version": "21",
      "published_date": "2025-01-30"
    }
  },
  "productid": "65162-469_f4ebff86-0b26-41a2-9b3f-6bb4dabbe385",
  "productndc": "65162-469",
  "dosage_form": "RING",
  "orange_book": {
    "appl_no": "210830",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.015MG/24HR;0.12MG/24HR",
        "product_no": "001",
        "approval_date": "Dec 11, 2019"
      }
    ],
    "appl_type": "A"
  },
  "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": "EluRyng",
  "active_ingred_unit": "mg/d; mg/d",
  "application_number": "ANDA210830",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Etonogestrel and Ethinyl Estradiol",
  "start_marketing_date": "20191216",
  "active_numerator_strength": ".015; .12"
}

Related drugs

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