Prescription drug · ANDA
Deferiprone NDC 0054-0576
Deferiprone 500 mg/1 · Tablet, Coated · Oral · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0054-0576-25 | 0005405762500054057625 | 100 TABLET, COATED in 1 BOTTLE (0054-0576-25)Marketed from Jun 3, 2021 |
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 — 500 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Hikma Pharmaceuticals USA Inc.NDC labeler code 0054
- 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 0054-0576_85bc2162-59ea-409a-94c2-0edef74922f5SPL ID 85bc2162-59ea-409a-94c2-0edef74922f5SPL set ID d7ea0a84-c328-4636-8cd6-ad75f2074b22RxCUI 389242UNII 2BTY8KH53LUPC 0300540576288, 0300540576257
- 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
N400054057625followed by a unit qualifier and the quantityPackage 00054-0576-25. 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.
About NDC 0054-0576
- What is NDC 0054-0576?
- 0054-0576 is the product NDC for Deferiprone, Deferiprone 500 mg/1 tablet, coated, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Deferiprone.
- What is the active ingredient?
- Deferiprone.
- Who is the labeler?
- Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Deferiprone?
- 6 other product NDCs are listed under this name. See all Deferiprone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Deferiprone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Deferiprone | Deferiprone 500 mg/1 | TabletOral | AvKARE | 73190-095 | 73190-0095-01 |
| Deferiprone | Deferiprone 1000 mg/1 | Tablet, CoatedOral | DR. REDDY'S LABORATORIES, INC. | 75907-348 | 75907-0348-50 |
| Deferiprone | Deferiprone 500 mg/1 | Tablet, CoatedOral | DR. REDDY'S LABORATORIES, INC. | 75907-349 | 75907-0349-01 |
| Deferiprone | Deferiprone 500 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 51672-4196 | 51672-4196-01 |
| Deferiprone | Deferiprone 1000 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 51672-4237 | 51672-4237-04 |
| Deferiprone | Deferiprone 1000 mg/1 | Tablet, CoatedOral | Hikma Pharmaceuticals USA Inc. | 0054-0711 | 00054-0711-1900054-0711-2300054-0711-28 |
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 1000 mg/1 | Tablet, CoatedOral | Hikma Pharmaceuticals USA Inc. | 0054-0711 |