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United States · US · US:0642-7471_f48a4726-8731-6fcb-e053-2995a90a6bea

Tyblume

Orange Book

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

Identification

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

Packs · 2

  • ndc11
    0642747101
    1 BLISTER PACK in 1 BOX (0642-7471-01) / 1 KIT in 1 BLISTER PACK
  • ndc11
    0642747102
    1 BLISTER PACK in 1 BOX (0642-7471-02) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book
N209405
Raw payload (JSON)
{
  "route": null,
  "productid": "0642-7471_f48a4726-8731-6fcb-e053-2995a90a6bea",
  "productndc": "0642-7471",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "209405",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.02MG;0.1MG",
        "product_no": "001",
        "approval_date": "Mar 30, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Tyblume",
  "active_ingred_unit": null,
  "application_number": "NDA209405",
  "marketing_category": "NDA",
  "nonproprietary_name": "Levonorgestrel and Ethinyl Estradiol",
  "start_marketing_date": "20201026",
  "active_numerator_strength": null
}

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