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United States · US · US:70700-122_a76528bf-413e-fde6-6b5c-6bb35a1b63d8

Volnea

Orange BookSPL

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

Identification

ManufacturerXiromed, LLC.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7070012285
    3 CARTON in 1 CARTON (70700-122-85) / 1 BLISTER PACK in 1 CARTON (70700-122-84) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book
A202689
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "0e65209d-329a-4d31-8afb-24348dc8d7e7": {
      "match": "brand_token",
      "title": "VOLNEA (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [BRYANT RANCH PREPACK]",
      "spl_version": "103",
      "published_date": "2024-01-12"
    }
  },
  "productid": "70700-122_a76528bf-413e-fde6-6b5c-6bb35a1b63d8",
  "productndc": "70700-122",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "202689",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.15MG,N/A;0.02MG,0.01MG",
        "product_no": "001",
        "approval_date": "Sep 9, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Volnea",
  "active_ingred_unit": null,
  "application_number": "ANDA202689",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Desogestrel and Ethinyl Estradiol",
  "start_marketing_date": "20171201",
  "active_numerator_strength": null
}

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