NDC 59922-631 – Auryxia
Tetraferric Tricitrate Decahydrate 210 mg/1 · Tablet, Film Coated · Oral
Product NDC59922-631
Product details
- Brand name
- Auryxia
- Generic name
- Ferric citrate
- Labeler
- Akebia Therapeutics, Inc.
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Marketing category
- NDA · NDA205874
- Marketed since
- September 17, 2014
- Listing expires
- December 31, 2026
- Pharmacologic class
- Parenteral Iron Replacement; Phosphate Binder
Active ingredients
- Tetraferric Tricitrate Decahydrate 210 mg/1
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 59922-631-01 | 200 TABLET, FILM COATED in 1 BOTTLE (59922-631-01) | Sep 17, 2014 |
Recalls mentioning this NDC
- D-0499-2021 Jun 2, 2021 · Class II
CGMP Deviations: Intermittent exposure to temperature excursion during storage. - D-0170-2021 Dec 30, 2020 · Class II
CGMP Deviations - D-1389-2020 Jul 22, 2020 · Class II
cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia. - D-0133-2018 Jan 3, 2018 · Class III
Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant potentially allowing the silica gel granules to make contact with Auryxia tablets…