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United States · US · US:0093-7679_d0827dbf-9df5-4438-a0c2-92d7d593e71c

Etonogestrel and Ethinyl Estradiol

In shortageOrange BookUNIISPLATC G03CA

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

Identification

ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeG03CA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0093767902
    3 POUCH in 1 CARTON (0093-7679-02) / 21 d in 1 POUCH (0093-7679-01)

Annotations

UNII (FDA Substance ID)
423D2T571U
ETHINYL ESTRADIOL
RxCUI 4124
Orange Book
A204305
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": "0093-7679_d0827dbf-9df5-4438-a0c2-92d7d593e71c",
  "productndc": "0093-7679",
  "dosage_form": "INSERT, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "204305",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.015MG/24HR;0.12MG/24HR",
        "product_no": "001",
        "approval_date": "Jan 13, 2021"
      }
    ],
    "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",
  "active_ingred_unit": "mg/d; mg/d",
  "application_number": "ANDA204305",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Etonogestrel and Ethinyl Estradiol",
  "start_marketing_date": "20210119",
  "active_numerator_strength": ".015; .12"
}

Related drugs

Other records sharing ATC code G03CA.

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