Prescription drug · ANDA
Deferiprone NDC 0054-0711
Deferiprone 1000 mg/1 · Tablet, Coated · Oral · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0054-0711-19 | 00054071119 | 50 TABLET, COATED in 1 BOTTLE (0054-0711-19)Marketed from Feb 8, 2022 | |
| 0054-0711-23 | 00054071123 | 150 TABLET, COATED in 1 BOTTLE (0054-0711-23)Marketed from Feb 8, 2022 | |
| 0054-0711-28 | 00054071128 | 300 TABLET, COATED in 1 BOTTLE (0054-0711-28)Marketed from Feb 8, 2022 |
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)
- Deferiprone
- Generic name (nonproprietary)
- deferiprone
- Active ingredients
- Deferiprone — 1000 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213239
- Marketing start
- Listing expires
- Other FDA classes
- Iron Chelating Activity (Mechanism)
- Identifiers
- Product ID 0054-0711_db72caee-70a3-4561-b855-08b4c9f4a0e0SPL ID db72caee-70a3-4561-b855-08b4c9f4a0e0SPL set ID c4f9e9be-39e7-4940-9cb0-f17772d7e524RxCUI 2180997UNII 2BTY8KH53LUPC 0300540711191
- 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
N400054071119followed by a unit qualifier and the quantityPackage 00054-0711-19. 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. 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. Pediatric use information is approved for Chiesi USA, Inc.’s FERRIPROX ® (deferiprone) tablets. However, due to Chiesi USA, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. Deferiprone tablets are an iron chelator indicated for the treatment of transfusional iron overload …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213239
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 | Tablet, CoatedOral | Hikma Pharmaceuticals USA Inc. | 0054-0576 |