Prescription drug · ANDA
Deferiprone NDC 51672-4237
Deferiprone 1000 mg/1 · Tablet · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51672-4237-4 | 51672423704 | 50 TABLET in 1 BOTTLE (51672-4237-4)Marketed from Feb 5, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Deferiprone
- Generic name (nonproprietary)
- deferiprone
- Active ingredients
- Deferiprone — 1000 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208800
- Marketing start
- Listing expires
- Other FDA classes
- Iron Chelating Activity (Mechanism)
- Identifiers
- Product ID 51672-4237_3631d351-4653-3512-e063-6394a90a81c0SPL ID 3631d351-4653-3512-e063-6394a90a81c0SPL set ID 5af1643d-4c6e-4668-ae9b-1046f0ad6d8aRxCUI 389242, 2180997UNII 2BTY8KH53L
- 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
N451672423704followed by a unit qualifier and the quantityPackage 51672-4237-04. 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)
Deferiprone tablets are indicated for the treatment of transfusional iron overload in adult patients with thalassemia syndromes when current chelation therapy is inadequate. Deferiprone tablets are an iron chelator indicated for the treatment of transfusional iron overload in adult patients with thalassemia syndromes when current chelation therapy is inadequate. ( 1 ) Limitations of Use Safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with myelodysplastic syndrome or in patients with Diamond Blackfan anemia. Limitations of Use Safety and effectiveness have not been established for the treatment of transfusional iron overload in p…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208800
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 |
|---|---|---|---|---|
| Deferiprone | Deferiprone 500 mg/1 | TabletOral | AvKARE | 73190-095 |
| Deferiprone | Deferiprone 500 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 51672-4196 |