Prescription drug · ANDA
Deferasirox NDC 46708-410
Deferasirox 90 mg/1 · Tablet, Film coated · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-410-30 | 4670804103046708041030 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-410-30)Marketed from Nov 21, 2019 | |
| 46708-410-91 | 4670804109146708041091 | 1000 TABLET, FILM COATED in 1 BOTTLE (46708-410-91)Marketed from Nov 21, 2019 |
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 — 90 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals LimitedNDC labeler code 46708
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211824
- 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 46708-410_d58c204e-f996-4969-85c7-3fbe078bf6a8SPL ID d58c204e-f996-4969-85c7-3fbe078bf6a8SPL set ID dd9450f4-7c95-4322-8806-9820570f5aa2RxCUI 1607784, 1607792, 1607796UNII V8G4MOF2V9UPC 0346708411305, 0346708412302, 0346708410308
- 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
N446708041030followed by a unit qualifier and the quantityPackage 46708-0410-30. 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. 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 Transfusions (Transfusional Iron Overload) Deferasirox tablets are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation’s JADENU ® (deferasirox) tablets. …
Excerpt only. Read the full label for complete information.
About NDC 46708-410
- What is NDC 46708-410?
- 46708-410 is the product NDC for Deferasirox, Deferasirox 90 mg/1 tablet, film coated, listed with the FDA by Alembic Pharmaceuticals Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Deferasirox.
- What is the active ingredient?
- Deferasirox.
- Who is the labeler?
- Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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?
- 75 other product NDCs are listed under this name. See all Deferasirox NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Deferasirox 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 | Deferasirox 360 mg/1 | TabletOral | AvKARE | 73190-052 | 73190-0052-30 |
| Deferasirox | Deferasirox 90 mg/1 | GranuleOral | Aurobindo Pharma Limited | 59651-447 | 59651-0447-30 |
| Deferasirox | Deferasirox 180 mg/1 | GranuleOral | Aurobindo Pharma Limited | 59651-448 | 59651-0448-30 |
| Deferasirox | Deferasirox 360 mg/1 | GranuleOral | Aurobindo Pharma Limited | 59651-449 | 59651-0449-30 |
| Deferasirox | Deferasirox 125 mg/1 | Tablet, For suspensionOral | Teva Pharmaceuticals, Inc. | 0480-7011 | 00480-7011-56 |
| Deferasirox | Deferasirox 250 mg/1 | Tablet, For suspensionOral | Teva Pharmaceuticals, Inc. | 0480-7012 | 00480-7012-56 |
| Deferasirox | Deferasirox 500 mg/1 | Tablet, For suspensionOral | Teva Pharmaceuticals, Inc. | 0480-7013 | 00480-7013-56 |
| Deferasirox | Deferasirox 360 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-412 | 59651-0412-30 |
| Deferasirox | Deferasirox 90 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-410 | 59651-0410-30 |
| Deferasirox | Deferasirox 180 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-411 | 59651-0411-30 |
Other NDCs under ANDA 211824
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 180 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-411 |
| Deferasirox | Deferasirox 360 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-412 |
| Deferasirox | Deferasirox 90 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-410 |
| Deferasirox | Deferasirox 180 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-411 |
| Deferasirox | Deferasirox 360 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-412 |