Prescription drug · NDA
Auryxia (ferric citrate) NDC 59922-631
Tetraferric tricitrate decahydrate 210 mg/1 · Tablet, Film coated · Oral · Akebia Therapeutics, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59922-631-01 | 59922063101 | 200 TABLET, FILM COATED in 1 BOTTLE (59922-631-01)Marketed from Sep 17, 2014 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Auryxia
- Generic name (nonproprietary)
- ferric citrate
- Active ingredients
- Tetraferric tricitrate decahydrate — 210 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Akebia Therapeutics, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 205874
- Marketing start
- Listing expires
- Other FDA classes
- Iron (Chemical structure)Phosphate Chelating Activity (Mechanism)
- Identifiers
- Product ID 59922-631_79cb63af-94fa-4f49-91d3-543c0058cd4eSPL ID 79cb63af-94fa-4f49-91d3-543c0058cd4eSPL set ID aadd18e0-3752-11e4-8510-0800200c9a66RxCUI 1594680, 1596023UNII Q91187K011
- Pharmacologic class
- Parenteral Iron Replacement; Phosphate Binder
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N459922063101followed by a unit qualifier and the quantityPackage 59922-0631-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Auryxia is a phosphate binder indicated for the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis. ( 1 ) Auryxia is an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease not on dialysis. ( 1 ) 1.1 Hyperphosphatemia in Chronic Kidney Disease on Dialysis Auryxia is indicated for the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis. 1.2 Iron Deficiency Anemia in Chronic Kidney Disease Not on Dialysis Auryxia is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease not on dialysis.…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 205874
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Ferric Citrate | Tetraferric tricitrate decahydrate 210 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-2895 |