Deferasirox NDC 69238-1488

NDC codes

FDA NDC Directory

Product NDC (as listed)69238-1488Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69238-1488Add 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 NDC	11-digit (billing)	Package	Copy
69238-1488-3	69238148803	30 TABLET, FILM COATED in 1 BOTTLE (69238-1488-3)Marketed from Jan 2, 2020

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): Deferasirox
Generic name (nonproprietary): deferasirox
Active ingredients: Deferasirox — 360 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Amneal Pharmaceuticals NY LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210727
Marketing start: Jan 2, 2020
Listing expires: Dec 31, 2026
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 69238-1488_0b0b3d91-33d4-46b8-8bdc-fb9b5a9e99c7SPL ID 0b0b3d91-33d4-46b8-8bdc-fb9b5a9e99c7SPL set ID a7ae9c31-e14f-4cf9-9ab3-850519f1a87cRxCUI 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

N469238148803 followed by a unit qualifier and the quantity

Package 69238-1488-03. 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 Oct 29, 2020. This label includes a boxed warning.

Indications (excerpt from the label)

Deferasirox 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 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 tablets when administered with other iron chelation therapy have not been established. ( 1.3 ) 1.1 Treatment of Chronic Iron Overload Due to Blood Transfusions (Tra…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210727

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

FDA NDC Directory listings under ANDA 210727
Product	Strength	Form · route	Labeler	Product NDC
Deferasirox	Deferasirox 180 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals NY LLC	69238-1487
Deferasirox	Deferasirox 90 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals NY LLC	69238-1486