Prescription drug · NDA
Jadenu (Deferasirox) NDC 0078-0655
Deferasirox 180 mg/1 · Tablet, Film coated · Oral · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0078-0655-15 | 00078065515 | 30 TABLET, FILM COATED in 1 BOTTLE (0078-0655-15)Marketed from Mar 30, 2015 |
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)
- Jadenu
- Generic name (nonproprietary)
- deferasirox
- Active ingredients
- Deferasirox — 180 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Novartis Pharmaceuticals CorporationNDC labeler code 0078
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 206910
- 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 0078-0655_028e6158-3b78-41dd-99a8-6acb582f7245SPL ID 028e6158-3b78-41dd-99a8-6acb582f7245SPL set ID fee89140-fff1-4443-9f42-24ac004fcda1RxCUI 1607784, 1607790, 1607792, 1607794, 1607796, 1607798, 1923822, 1923825, 1923826, 1923827, 1923828, 1923829UNII 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
N400078065515followed by a unit qualifier and the quantityPackage 00078-0655-15. 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)
JADENU 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 ) JADENU 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 JADENU 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 Overloa…
Excerpt only. Read the full label for complete information.
About NDC 0078-0655
- What is NDC 0078-0655?
- 0078-0655 is the product NDC for Jadenu (deferasirox), Deferasirox 180 mg/1 tablet, film coated, 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?
- Jadenu (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 Jadenu?
- 5 other product NDCs are listed under this name. See all Jadenu NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Jadenu products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Jadenudeferasirox | Deferasirox 180 mg/1 | GranuleOral | Novartis Pharmaceuticals Corporation | 0078-0713 | 00078-0713-15 |
| Jadenudeferasirox | Deferasirox 360 mg/1 | GranuleOral | Novartis Pharmaceuticals Corporation | 0078-0720 | 00078-0720-15 |
| Jadenudeferasirox | Deferasirox 90 mg/1 | GranuleOral | Novartis Pharmaceuticals Corporation | 0078-0727 | 00078-0727-15 |
| Jadenudeferasirox | Deferasirox 90 mg/1 | Tablet, Film coatedOral | Novartis Pharmaceuticals Corporation | 0078-0654 | 00078-0654-15 |
| Jadenudeferasirox | Deferasirox 360 mg/1 | Tablet, Film coatedOral | Novartis Pharmaceuticals Corporation | 0078-0656 | 00078-0656-15 |
Other NDCs under NDA 206910
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 |
|---|---|---|---|---|
| Jadenudeferasirox | Deferasirox 90 mg/1 | Tablet, Film coatedOral | Novartis Pharmaceuticals Corporation | 0078-0654 |
| Jadenudeferasirox | Deferasirox 360 mg/1 | Tablet, Film coatedOral | Novartis Pharmaceuticals Corporation | 0078-0656 |