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United States · US · US:59922-631_79cb63af-94fa-4f49-91d3-543c0058cd4e

Auryxia

Orange BookUNIISPL

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

Identification

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

Packs · 1

  • ndc11
    5992263101
    200 TABLET, FILM COATED in 1 BOTTLE (59922-631-01)

Annotations

UNII (FDA Substance ID)
Q91187K011
TETRAFERRIC TRICITRATE DECAHYDRATE
Orange Book
N205874
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "Q91187K011",
    "rxcui": null,
    "inchikey": "UISKQNNAQKPSDO-UHFFFAOYSA-E",
    "display_name": "TETRAFERRIC TRICITRATE DECAHYDRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "aadd18e0-3752-11e4-8510-0800200c9a66": {
      "match": "brand_token",
      "title": "AURYXIA (FERRIC CITRATE) TABLET, FILM COATED [AKEBIA THERAPEUTICS, INC.]",
      "spl_version": "27",
      "published_date": "2025-12-18"
    }
  },
  "productid": "59922-631_79cb63af-94fa-4f49-91d3-543c0058cd4e",
  "productndc": "59922-631",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "205874",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 210MG IRON",
        "product_no": "001",
        "approval_date": "Sep 5, 2014"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TETRAFERRIC TRICITRATE DECAHYDRATE",
  "proprietary_name": "Auryxia",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA205874",
  "marketing_category": "NDA",
  "nonproprietary_name": "ferric citrate",
  "start_marketing_date": "20140917",
  "active_numerator_strength": "210"
}

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