Prescription drug · ANDA
Deferasirox NDC 46708-325
Deferasirox 250 mg/1 · Tablet, For suspension · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-325-30 | 46708032530 | 30 TABLET, FOR SUSPENSION in 1 BOTTLE (46708-325-30)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 — 250 mg/1
- Dosage form
- Tablet, For suspension
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210060
- 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 46708-325_3b7b2b3c-507c-4ea9-a45d-f5e38f9e1b80SPL ID 3b7b2b3c-507c-4ea9-a45d-f5e38f9e1b80SPL set ID 8c8b84f3-6887-4485-b5e0-03f254b88a15RxCUI 597768, 597770, 597772UNII V8G4MOF2V9UPC 0346708326302, 0346708325305
- 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
N446708032530followed by a unit qualifier and the quantityPackage 46708-0325-30. 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 for oral suspension 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) Limitations of Use: The safety and efficacy of deferasirox tablets for oral suspension 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 for oral suspension 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 Novar…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210060
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 125 mg/1 | Tablet, For suspensionOral | Alembic Pharmaceuticals Limited | 46708-324 |
| Deferasirox | Deferasirox 500 mg/1 | Tablet, For suspensionOral | Alembic Pharmaceuticals Limited | 46708-326 |
| Deferasirox | Deferasirox 250 mg/1 | Tablet, For suspensionOral | Alembic Pharmaceuticals Inc. | 62332-325 |
| Deferasirox | Deferasirox 125 mg/1 | Tablet, For suspensionOral | Alembic Pharmaceuticals Inc. | 62332-324 |
| Deferasirox | Deferasirox 500 mg/1 | Tablet, For suspensionOral | Alembic Pharmaceuticals Inc. | 62332-326 |