Prescription drug · NDA
Vafseo (vadadustat) NDC 59922-641
Vadadustat 150 mg/1 · Tablet, Film coated · Oral · Akebia Therapeutics, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59922-641-60 | 59922064160 | 1 BOTTLE in 1 CARTON (59922-641-60) / 60 TABLET, FILM COATED in 1 BOTTLEMarketed from Mar 28, 2024 |
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)
- Vafseo
- Generic name (nonproprietary)
- vadadustat
- Active ingredients
- Vadadustat — 150 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Akebia Therapeutics, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 215192
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors (Mechanism)Organic Anion Transporter 3 Inhibitors (Mechanism)
- Identifiers
- Product ID 59922-641_400c5380-cfe8-4495-bdd0-12608d197860SPL ID 400c5380-cfe8-4495-bdd0-12608d197860SPL set ID ac9da724-5a62-4ab6-a89c-376a25f6195bRxCUI 2679301, 2679307, 2679309, 2679311, 2679313, 2679315UNII I60W9520VVUPC 0359922643605, 0359922642608, 0359922641601
- Pharmacologic class
- Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor
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
N459922064160followed by a unit qualifier and the quantityPackage 59922-0641-60. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
VAFSEO is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. Limitations of Use VAFSEO has not been shown to improve quality of life, fatigue, or patient well-being. VAFSEO is not indicated for use: As a substitute for red blood cell transfusions in patients who require immediate correction of anemia In patients with anemia due to CKD not on dialysis [see Warnings and Precautions ( 5.6 )] . VAFSEO is a hypoxia-inducible factor prolyl hydroxylase (HIF PH) inhibitor indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three mo…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 215192
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.