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United States · US · US:68308-752_88f47600-fe7d-4744-be8d-e29dde1711e5

Annovera

In shortageOrange BookUNIISPLATC G03CA

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

Identification

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

Packs · 1

  • ndc11
    6830875201
    1 POUCH in 1 CARTON (68308-752-01) / 30 RING in 1 POUCH

Annotations

UNII (FDA Substance ID)
423D2T571U
ETHINYL ESTRADIOL
RxCUI 4124
Orange Book
N209627
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": {
    "eb18194f-2021-41fa-8bdf-31e0c0eb646b": {
      "match": "brand_token",
      "title": "ANNOVERA (SEGESTERONE ACETATE AND ETHINYL ESTRADIOL) RING [MAYNE PHARMA]",
      "spl_version": "5",
      "published_date": "2025-04-25"
    }
  },
  "productid": "68308-752_88f47600-fe7d-4744-be8d-e29dde1711e5",
  "productndc": "68308-752",
  "dosage_form": "RING",
  "orange_book": {
    "appl_no": "209627",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.013MG/24HR;0.15MG/24HR",
        "product_no": "001",
        "approval_date": "Aug 10, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ETHINYL ESTRADIOL; SEGESTERONE ACETATE",
  "shortage_reason": "Ethinyl Estradiol; Ethinyl Diacetate Tablet",
  "shortage_status": "current",
  "proprietary_name": "Annovera",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA209627",
  "marketing_category": "NDA",
  "nonproprietary_name": "segesterone acetate and ethinyl estradiol",
  "start_marketing_date": "20240816",
  "active_numerator_strength": "17.4; 103"
}

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