Prescription drug · NDA
Exjade (Deferasirox) NDC 0078-0470
Deferasirox 500 mg/1 · Tablet, For suspension · Oral · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0078-0470-15 | 0007804701500078047015 | 30 TABLET, FOR SUSPENSION in 1 BOTTLE (0078-0470-15)Marketed from Nov 30, 2005 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Exjade
- Generic name (nonproprietary)
- deferasirox
- Active ingredients
- Deferasirox — 500 mg/1
- Dosage form
- Tablet, For suspension
- Route
- Oral
- Labeler
- Novartis Pharmaceuticals CorporationNDC labeler code 0078
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021882
- 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 0078-0470_17c39217-5502-420d-8d2e-799626756189SPL ID 17c39217-5502-420d-8d2e-799626756189SPL set ID 3495a70c-870c-4968-940e-8baea152cf85RxCUI 597768, 597770, 597772, 616159, 616161, 616163UNII 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
N400078047015followed by a unit qualifier and the quantityPackage 00078-0470-15. 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)
Exjade 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 ) Exjade 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 and a serum ferritin greater than 300 mcg/L. ( 1.2 ) Limitations of Use: The safety and efficacy of Exjade when administered with other iron chelation therapy have not been established. ( 1.3 ) 1.1 Treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload) Exjade …
Excerpt only. Read the full label for complete information.
About NDC 0078-0470
- What is NDC 0078-0470?
- 0078-0470 is the product NDC for Exjade (deferasirox), Deferasirox 500 mg/1 tablet, for suspension, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Exjade (Deferasirox).
- What is the active ingredient?
- Deferasirox.
- Who is the labeler?
- Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Exjade?
- 2 other product NDCs are listed under this name. See all Exjade NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Exjade products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Exjadedeferasirox | Deferasirox 125 mg/1 | Tablet, For suspensionOral | Novartis Pharmaceuticals Corporation | 0078-0468 | 00078-0468-15 |
| Exjadedeferasirox | Deferasirox 250 mg/1 | Tablet, For suspensionOral | Novartis Pharmaceuticals Corporation | 0078-0469 | 00078-0469-15 |
Other NDCs under NDA 021882
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 |
|---|---|---|---|---|
| Exjadedeferasirox | Deferasirox 125 mg/1 | Tablet, For suspensionOral | Novartis Pharmaceuticals Corporation | 0078-0468 |
| Exjadedeferasirox | Deferasirox 250 mg/1 | Tablet, For suspensionOral | Novartis Pharmaceuticals Corporation | 0078-0469 |