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United States · US · US:50102-231_bb0e872b-05ee-4e30-bc1f-808f2c533e5d

Tri-VyLibra Lo

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 · 1

  • ndc11
    5010223113
    3 PACKAGE in 1 CARTON (50102-231-13) / 1 BLISTER PACK in 1 PACKAGE (50102-231-11) / 1 KIT in 1 BLISTER PACK (50102-231-01)

Annotations

Orange Book
A205762
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": "50102-231_bb0e872b-05ee-4e30-bc1f-808f2c533e5d",
  "productndc": "50102-231",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "205762",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG",
        "product_no": "001",
        "approval_date": "Nov 4, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Tri-VyLibra Lo",
  "active_ingred_unit": null,
  "application_number": "ANDA205762",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Norgestimate and Ethinyl Estradiol",
  "start_marketing_date": "20161104",
  "active_numerator_strength": null
}

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