auryxia

Generic: ferric citrate

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

Drug Facts

Product Profile

Brand Name auryxia
Generic Name ferric citrate
Labeler akebia therapeutics, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tetraferric tricitrate decahydrate 210 mg/1

Manufacturer
Akebia Therapeutics, Inc.

Identifiers & Regulatory

Product NDC 59922-631
Product ID 59922-631_79cb63af-94fa-4f49-91d3-543c0058cd4e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205874
Listing Expiration 2026-12-31
Marketing Start 2014-09-17

Pharmacologic Class

Classes
iron [cs] parenteral iron replacement [epc] phosphate binder [epc] phosphate chelating activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59922631
Hyphenated Format 59922-631

Supplemental Identifiers

RxCUI
1594680 1596023
UNII
Q91187K011

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 auryxia (source: ndc)
Generic Name ferric citrate (source: ndc)
Application Number NDA205874 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 210 mg/1
source: ndc
Packaging
  • 200 TABLET, FILM COATED in 1 BOTTLE (59922-631-01)
source: ndc

Packages (1)

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

Ingredients (1)

tetraferric tricitrate decahydrate (210 mg/1)

Linked Drug Pages (1)

Auryxia ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "79cb63af-94fa-4f49-91d3-543c0058cd4e", "openfda": {"unii": ["Q91187K011"], "rxcui": ["1594680", "1596023"], "spl_set_id": ["aadd18e0-3752-11e4-8510-0800200c9a66"], "manufacturer_name": ["Akebia Therapeutics, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "200 TABLET, FILM COATED in 1 BOTTLE (59922-631-01)", "package_ndc": "59922-631-01", "marketing_start_date": "20140917"}], "brand_name": "Auryxia", "product_id": "59922-631_79cb63af-94fa-4f49-91d3-543c0058cd4e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Iron [CS]", "Parenteral Iron Replacement [EPC]", "Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]"], "product_ndc": "59922-631", "generic_name": "ferric citrate", "labeler_name": "Akebia Therapeutics, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Auryxia", "active_ingredients": [{"name": "TETRAFERRIC TRICITRATE DECAHYDRATE", "strength": "210 mg/1"}], "application_number": "NDA205874", "marketing_category": "NDA", "marketing_start_date": "20140917", "listing_expiration_date": "20261231"}