Prescription drug · ANDA
Deferasirox NDC 59651-412
Deferasirox 360 mg/1 · Tablet, Film coated · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-412-30 | 59651041230 | 30 TABLET, FILM COATED in 1 BOTTLE (59651-412-30)Marketed from Oct 16, 2023 |
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
- Tablet, Film coated
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214474
- 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 59651-412_3b584d19-7a28-43b4-86db-756caf83709aSPL ID 3b584d19-7a28-43b4-86db-756caf83709aSPL set ID c7f14819-1abc-4abf-b55b-cf89beaf124eRxCUI 1607784, 1607792, 1607796UNII 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
N459651041230followed by a unit qualifier and the quantityPackage 59651-0412-30. 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 tablets 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 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 tablets when administered with other iron chelation therapy have not been established. ( 1.3 ) 1.1 Treatment of Chronic Iron Overload Due to Blood…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214474
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 90 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 72603-231 |
| Deferasirox | Deferasirox 180 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 72603-232 |
| Deferasirox | Deferasirox 360 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 72603-233 |
| Deferasirox | Deferasirox 90 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-410 |
| Deferasirox | Deferasirox 180 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-411 |