VAFSEO

Orange BookUNIISPLATC B03XA08

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAkebia Therapeutics, Inc.

CountryUS (United States)

ATC codeB03XA08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5992264260
1 BOTTLE in 1 CARTON (59922-642-60) / 60 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

I60W9520VV

VADADUSTAT

Orange Book

N215192

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "I60W9520VV",
    "rxcui": null,
    "inchikey": "JGRXMPYUTJLTKT-UHFFFAOYSA-N",
    "display_name": "VADADUSTAT",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "ac9da724-5a62-4ab6-a89c-376a25f6195b": {
      "match": "brand_token",
      "title": "VAFSEO (VADADUSTAT) TABLET, FILM COATED [AKEBIA THERAPEUTICS, INC.]",
      "spl_version": "4",
      "published_date": "2026-04-15"
    }
  },
  "productid": "59922-642_400c5380-cfe8-4495-bdd0-12608d197860",
  "productndc": "59922-642",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "215192",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "Mar 27, 2024"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Mar 27, 2024"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "450MG",
        "product_no": "003",
        "approval_date": "Mar 27, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VADADUSTAT",
  "proprietary_name": "VAFSEO",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA215192",
  "marketing_category": "NDA",
  "nonproprietary_name": "Vadadustat",
  "start_marketing_date": "20240328",
  "active_numerator_strength": "300"
}

Related drugs

Other records sharing ATC code B03XA08.

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