vafseo

Generic: vadadustat

Labeler: akebia therapeutics, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name vafseo
Generic Name vadadustat
Labeler akebia therapeutics, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

vadadustat 300 mg/1

Manufacturer
Akebia Therapeutics, Inc.

Identifiers & Regulatory

Product NDC 59922-642
Product ID 59922-642_86ed554e-938d-4f6a-abba-672284f21ca5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215192
Listing Expiration 2026-12-31
Marketing Start 2024-03-28

Pharmacologic Class

Established (EPC)
hypoxia-inducible factor prolyl hydroxylase inhibitor [epc]
Mechanism of Action
hypoxia-inducible factor prolyl hydroxylase inhibitors [moa] breast cancer resistance protein inhibitors [moa] organic anion transporter 3 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59922642
Hyphenated Format 59922-642

Supplemental Identifiers

RxCUI
2679301 2679307 2679309 2679311 2679313 2679315
UPC
0359922643605 0359922642608 0359922641601
UNII
I60W9520VV
NUI
N0000194080 N0000194079 N0000190113 N0000190111

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name vafseo (source: ndc)
Generic Name vadadustat (source: ndc)
Application Number NDA215192 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (59922-642-60) / 60 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (1)

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

Ingredients (1)

vadadustat (300 mg/1)

Linked Drug Pages (1)

VAFSEO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "86ed554e-938d-4f6a-abba-672284f21ca5", "openfda": {"nui": ["N0000194080", "N0000194079", "N0000190113", "N0000190111"], "upc": ["0359922643605", "0359922642608", "0359922641601"], "unii": ["I60W9520VV"], "rxcui": ["2679301", "2679307", "2679309", "2679311", "2679313", "2679315"], "spl_set_id": ["ac9da724-5a62-4ab6-a89c-376a25f6195b"], "pharm_class_epc": ["Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor [EPC]"], "pharm_class_moa": ["Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors [MoA]", "Breast Cancer Resistance Protein Inhibitors [MoA]", "Organic Anion Transporter 3 Inhibitors [MoA]"], "manufacturer_name": ["Akebia Therapeutics, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (59922-642-60)  / 60 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "59922-642-60", "marketing_start_date": "20240328"}], "brand_name": "VAFSEO", "product_id": "59922-642_86ed554e-938d-4f6a-abba-672284f21ca5", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Breast Cancer Resistance Protein Inhibitors [MoA]", "Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors [MoA]", "Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor [EPC]", "Organic Anion Transporter 3 Inhibitors [MoA]"], "product_ndc": "59922-642", "generic_name": "Vadadustat", "labeler_name": "Akebia Therapeutics, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VAFSEO", "active_ingredients": [{"name": "VADADUSTAT", "strength": "300 mg/1"}], "application_number": "NDA215192", "marketing_category": "NDA", "marketing_start_date": "20240328", "listing_expiration_date": "20261231"}