Prescription drug · ANDA
Deferasirox NDC 59651-449
Deferasirox 360 mg/1 · Granule · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-449-30 | 59651044930 | 30 PACKET in 1 CARTON (59651-449-30) / 1 GRANULE in 1 PACKET (59651-449-54)Marketed from Sep 8, 2025 |
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)
- Deferasirox
- Generic name (nonproprietary)
- deferasirox
- Active ingredients
- Deferasirox — 360 mg/1
- Dosage form
- Granule
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215137
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 1A2 Inhibitors (Mechanism)Cytochrome P450 2C8 Inhibitors (Mechanism)Cytochrome P450 3A4 Inducers (Mechanism)Iron Chelating Activity (Mechanism)
- Identifiers
- Product ID 59651-449_c220484e-1e6a-4a0c-a221-60223f3bc24cSPL ID c220484e-1e6a-4a0c-a221-60223f3bc24cSPL set ID c220484e-1e6a-4a0c-a221-60223f3bc24cRxCUI 1923822, 1923826, 1923828UNII V8G4MOF2V9
- Pharmacologic class
- Iron Chelator
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
N459651044930followed by a unit qualifier and the quantityPackage 59651-0449-30. 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)
Deferasirox oral granules are iron chelators indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. ( 1.1 ) Deferasirox oral granules are indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight (Fe/g dw) and a serum ferritin greater than 300 mcg/L. ( 1.2 ) Limitations of Use: The safety and efficacy of deferasirox oral granules when administered with other iron chelation therapy have not been established. ( 1.3 ) 1.1 Treatment of Chronic Iron Overl…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 215137
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 |
|---|---|---|---|---|
| Deferasirox | Deferasirox 180 mg/1 | GranuleOral | Aurobindo Pharma Limited | 59651-448 |
| Deferasirox | Deferasirox 90 mg/1 | GranuleOral | Aurobindo Pharma Limited | 59651-447 |