Prescription drug · ANDA
Deferasirox Oral Granules (Deferasirox) NDC 42806-371
Deferasirox 90 mg/1 · Granule · Oral · EPIC PHARMA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42806-371-30 | 42806037130 | 30 PACKET in 1 CARTON (42806-371-30) / 1 GRANULE in 1 PACKETMarketed from Oct 6, 2022 |
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 Oral Granules
- Generic name (nonproprietary)
- deferasirox
- Active ingredients
- Deferasirox — 90 mg/1
- Dosage form
- Granule
- Route
- Oral
- Labeler
- EPIC PHARMA, LLCNDC labeler code 42806
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214559
- 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 42806-371_2b205859-07ad-1703-e063-6394a90ac140SPL ID 2b205859-07ad-1703-e063-6394a90ac140SPL set ID 7eda83c3-a282-47f6-9f06-d2f9612f5c5bRxCUI 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
N442806037130followed by a unit qualifier and the quantityPackage 42806-0371-30. 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 is 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 is 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 42806-371
- What is NDC 42806-371?
- 42806-371 is the product NDC for Deferasirox Oral Granules (deferasirox), Deferasirox 90 mg/1 granule, listed with the FDA by EPIC PHARMA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Deferasirox Oral Granules (Deferasirox).
- What is the active ingredient?
- Deferasirox.
- Who is the labeler?
- EPIC PHARMA, LLC, NDC labeler code 42806. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Deferasirox Oral Granules?
- 2 other product NDCs are listed under this name. See all Deferasirox Oral Granules NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Deferasirox Oral Granules products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Deferasirox Oral Granulesdeferasirox | Deferasirox 360 mg/1 | GranuleOral | EPIC PHARMA, LLC | 42806-373 | 42806-0373-30 |
| Deferasirox Oral Granulesdeferasirox | Deferasirox 180 mg/1 | GranuleOral | EPIC PHARMA, LLC | 42806-372 | 42806-0372-30 |
Other NDCs under ANDA 214559
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 Oral Granulesdeferasirox | Deferasirox 360 mg/1 | GranuleOral | EPIC PHARMA, LLC | 42806-373 |
| Deferasirox Oral Granulesdeferasirox | Deferasirox 180 mg/1 | GranuleOral | EPIC PHARMA, LLC | 42806-372 |