NDC codes

FDA NDC Directory
Product NDC (as listed)0054-0576Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00054-0576Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0054-0576-250005405762500054057625100 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

N400054057625 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Deferiprone NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
DeferiproneDeferiprone 500 mg/1TabletOralAvKARE73190-09573190-0095-01
DeferiproneDeferiprone 1000 mg/1Tablet, CoatedOralDR. REDDY'S LABORATORIES, INC.75907-34875907-0348-50
DeferiproneDeferiprone 500 mg/1Tablet, CoatedOralDR. REDDY'S LABORATORIES, INC.75907-34975907-0349-01
DeferiproneDeferiprone 500 mg/1TabletOralSun Pharmaceutical Industries, Inc.51672-419651672-4196-01
DeferiproneDeferiprone 1000 mg/1TabletOralSun Pharmaceutical Industries, Inc.51672-423751672-4237-04
DeferiproneDeferiprone 1000 mg/1Tablet, CoatedOralHikma Pharmaceuticals USA Inc.0054-071100054-0711-1900054-0711-2300054-0711-28

Other NDCs under ANDA 213239

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 213239
ProductStrengthForm · routeLabelerProduct NDC
DeferiproneDeferiprone 1000 mg/1Tablet, CoatedOralHikma Pharmaceuticals USA Inc.0054-0711

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in