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United States · US · US:42291-478_1cbd9870-3ef2-b5c9-e063-6394a90a2dbd

Etonogestrel and Ethinyl Estradiol Vaginal

In shortageOrange BookUNIISPLATC G03CA

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

Identification

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

Packs · 1

  • ndc11
    4229147803
    3 POUCH in 1 CARTON (42291-478-03) / 21 d in 1 POUCH (42291-478-11)

Annotations

UNII (FDA Substance ID)
423D2T571U
ETHINYL ESTRADIOL
RxCUI 4124
Orange Book
A211157
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": "VAGINAL",
  "spl_meta": {
    "a8cc104a-d522-49ad-af54-2f312b829b61": {
      "match": "brand_token",
      "title": "ETONOGESTREL AND ETHINYL ESTRADIOL INSERT, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA, INC.]",
      "spl_version": "5",
      "published_date": "2025-09-10"
    }
  },
  "productid": "42291-478_1cbd9870-3ef2-b5c9-e063-6394a90a2dbd",
  "productndc": "42291-478",
  "dosage_form": "RING",
  "orange_book": {
    "appl_no": "211157",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.015MG/24HR;0.12MG/24HR",
        "product_no": "001",
        "approval_date": "Jun 29, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ETHINYL ESTRADIOL; ETONOGESTREL",
  "shortage_reason": "Ethinyl Estradiol; Etonogestrel Ring",
  "shortage_status": "current",
  "proprietary_name": "Etonogestrel and Ethinyl Estradiol Vaginal",
  "active_ingred_unit": "mg/d; mg/d",
  "application_number": "ANDA211157",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Etonogestrel and Ethinyl Estradiol Vaginal",
  "start_marketing_date": "20230921",
  "active_numerator_strength": ".015; .12"
}

Related drugs

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