Prescription drug · ANDA
Deferasirox NDC 72205-389
Deferasirox 125 mg/1 · Tablet, For suspension · Oral · Novadoz Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72205-389-01 | 72205038901 | 30 TABLET, FOR SUSPENSION in 1 BOTTLE (72205-389-01)Marketed from Jan 29, 2026 | |
| 72205-389-02 | 72205038902 | 90 TABLET, FOR SUSPENSION in 1 BOTTLE (72205-389-02)Marketed from Jan 29, 2026 | |
| 72205-389-03 | 72205038903 | 1000 TABLET, FOR SUSPENSION in 1 BOTTLE (72205-389-03)Marketed from Jan 29, 2026 | |
| 72205-389-05 | 72205038905 | 10 BLISTER PACK in 1 CARTON (72205-389-05) / 10 TABLET, FOR SUSPENSION in 1 BLISTER PACKMarketed from Jan 29, 2026 |
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 — 125 mg/1
- Dosage form
- Tablet, For suspension
- Route
- Oral
- Labeler
- Novadoz Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209878
- 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 72205-389_a03c7657-fdca-4acb-ad82-c24680e90eaeSPL ID a03c7657-fdca-4acb-ad82-c24680e90eaeSPL set ID a03c7657-fdca-4acb-ad82-c24680e90eaeRxCUI 597768, 597770, 597772UNII V8G4MOF2V9UPC 0372205389014, 0372205391017, 0372205390010
- 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
N472205038901followed by a unit qualifier and the quantityPackage 72205-0389-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Deferasirox tablets for oral suspension are an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. ( 1.1 ) Deferasirox tablets for oral suspension 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 and a serum ferritin greater than 300 mcg/L. ( 1.2 ) Limitations of Use: The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established. ( 1.3 ) 1.1 Treatment of Chronic Iron…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209878
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 125 mg/1 | Tablet, For suspensionOral | MSN LABORATORIES PRIVATE LIMITED | 69539-021 |
| Deferasirox | Deferasirox 250 mg/1 | Tablet, For suspensionOral | MSN LABORATORIES PRIVATE LIMITED | 69539-022 |
| Deferasirox | Deferasirox 500 mg/1 | Tablet, For suspensionOral | MSN LABORATORIES PRIVATE LIMITED | 69539-023 |
| Deferasirox | Deferasirox 250 mg/1 | Tablet, For suspensionOral | Dr. Reddy's Laboratories Inc | 43598-856 |
| Deferasirox | Deferasirox 250 mg/1 | Tablet, For suspensionOral | Novadoz Pharmaceuticals LLC | 72205-390 |
| Deferasirox | Deferasirox 125 mg/1 | Tablet, For suspensionOral | Dr. Reddy's Laboratories Inc | 43598-855 |
| Deferasirox | Deferasirox 500 mg/1 | Tablet, For suspensionOral | Dr. Reddy's Laboratories Inc | 43598-854 |
| Deferasirox | Deferasirox 500 mg/1 | Tablet, For suspensionOral | Novadoz Pharmaceuticals LLC | 72205-391 |