NDC codes

FDA NDC Directory
Product NDC (as listed)67877-553Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67877-0553Add 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
67877-553-306787705533030 TABLET, FILM COATED in 1 BOTTLE (67877-553-30)Marketed from Jul 4, 2020
67877-553-906787705539090 TABLET, FILM COATED in 1 BOTTLE (67877-553-90)Marketed from Jul 4, 2020

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 — 180 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210555
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 67877-553_5e8c386f-5879-4f68-bc6f-38041072f5adSPL ID 5e8c386f-5879-4f68-bc6f-38041072f5adSPL set ID 0fb210b3-6a3d-4313-83ce-52012e384f9bRxCUI 1607784, 1607792, 1607796UNII V8G4MOF2V9
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

N467877055330 followed by a unit qualifier and the quantity

Package 67877-0553-30. 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 is 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 ) Deferasirox tablets is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight (Fe/g dw) and a serum ferritin greater than 300 mcg/L. ( 1.2 ) Limitations of Use: The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established. ( 1.3 ) 1.1 Treatment of Chronic Iron Overload Due to Blood Transfusi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210555

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

FDA NDC Directory listings under ANDA 210555
ProductStrengthForm · routeLabelerProduct NDC
DeferasiroxDeferasirox 90 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-552
DeferasiroxDeferasirox 360 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-554

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