Prescription drug · ANDA
Deferasorox (Deferasirox) NDC 72205-076
Deferasirox 360 mg/1 · Granule · Oral · Novadoz Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72205-076-30 | 7220500763072205007630 | 30 PACKET in 1 CARTON (72205-076-30) / 1 GRANULE in 1 PACKET (72205-076-61)Marketed from Mar 18, 2021 |
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)
- Deferasorox
- Generic name (nonproprietary)
- deferasirox
- Active ingredients
- Deferasirox — 360 mg/1
- Dosage form
- Granule
- Route
- Oral
- Labeler
- Novadoz Pharmaceuticals LLCNDC labeler code 72205
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214650
- 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 72205-076_b2ff1a76-b564-4235-8275-89005d9c4a24SPL ID b2ff1a76-b564-4235-8275-89005d9c4a24SPL set ID 1122f1c0-c160-49db-a31b-90d7521370f5RxCUI 1923822, 1923826, 1923828UNII V8G4MOF2V9UPC 0372205076617, 0372205176614, 0372205075610
- 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
N472205007630followed by a unit qualifier and the quantityPackage 72205-0076-30. 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 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 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 Ove…
Excerpt only. Read the full label for complete information.
About NDC 72205-076
- What is NDC 72205-076?
- 72205-076 is the product NDC for Deferasorox (deferasirox), Deferasirox 360 mg/1 granule, listed with the FDA by Novadoz Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Deferasorox (Deferasirox).
- What is the active ingredient?
- Deferasirox.
- Who is the labeler?
- Novadoz Pharmaceuticals LLC, NDC labeler code 72205. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Deferasorox?
- 2 other product NDCs are listed under this name. See all Deferasorox NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Deferasorox products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Deferasoroxdeferasirox | Deferasirox 90 mg/1 | GranuleOral | Novadoz Pharmaceuticals LLC | 72205-176 | 72205-0176-30 |
| Deferasoroxdeferasirox | Deferasirox 180 mg/1 | GranuleOral | Novadoz Pharmaceuticals LLC | 72205-075 | 72205-0075-30 |
Other NDCs under ANDA 214650
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 |
|---|---|---|---|---|
| Deferasoroxdeferasirox | Deferasirox 180 mg/1 | GranuleOral | Novadoz Pharmaceuticals LLC | 72205-075 |
| Deferasoroxdeferasirox | Deferasirox 90 mg/1 | GranuleOral | Novadoz Pharmaceuticals LLC | 72205-176 |