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United States · US · US:0074-1017_92a6192f-7a2b-4bb7-be46-4664e07dcf44

Oriahnn

Orange BookSPL

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

Identification

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

Packs · 2

  • ndc11
    0074101714
    1 BLISTER PACK in 1 CARTON (0074-1017-14) / 1 KIT in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK
  • ndc11
    0074101756
    4 BLISTER PACK in 1 CARTON (0074-1017-56) / 1 KIT in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK

Annotations

Orange Book
N213388
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "99f6eee7-7e52-6999-7eb8-488d06dd1710": {
      "match": "brand_token",
      "title": "ORIAHNN (ELAGOLIX AND ESTRADIOL AND NORETHISTERONE) KIT [ABBVIE INC.]",
      "spl_version": "41",
      "published_date": "2025-12-24"
    }
  },
  "productid": "0074-1017_92a6192f-7a2b-4bb7-be46-4664e07dcf44",
  "productndc": "0074-1017",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "213388",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE",
        "product_no": "001",
        "approval_date": "May 29, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Oriahnn",
  "active_ingred_unit": null,
  "application_number": "NDA213388",
  "marketing_category": "NDA",
  "nonproprietary_name": "Elagolix and Estradiol and Norethisterone",
  "start_marketing_date": "20200529",
  "active_numerator_strength": null
}

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