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United States · US · US:50102-233_8f45527d-e6cf-4eda-ac01-29618a778122

Tri-VyLibra

Orange BookSPL

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

Identification

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

Packs · 2

  • ndc11
    5010223311
    1 BLISTER PACK in 1 CARTON (50102-233-11) / 1 KIT in 1 BLISTER PACK
  • ndc11
    5010223313
    3 BLISTER PACK in 1 CARTON (50102-233-13) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book
A205441
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "f59acc3e-21d9-4fa3-ad52-d77225739e1a": {
      "match": "brand_token",
      "title": "TRI-VYLIBRA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [AFAXYS PHARMA, LLC]",
      "spl_version": "10",
      "published_date": "2024-02-16"
    }
  },
  "productid": "50102-233_8f45527d-e6cf-4eda-ac01-29618a778122",
  "productndc": "50102-233",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "205441",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG",
        "product_no": "001",
        "approval_date": "Jul 6, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Tri-VyLibra",
  "active_ingred_unit": null,
  "application_number": "ANDA205441",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Norgestimate and Ethinyl Estradiol",
  "start_marketing_date": "20160706",
  "active_numerator_strength": null
}

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