deferasirox NDC 62756-568

NDC codes

FDA NDC Directory

Product NDC (as listed)62756-568Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62756-0568Add 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
62756-568-83	62756056883	30 TABLET, FOR SUSPENSION in 1 BOTTLE (62756-568-83)Marketed from Dec 2, 2019
62756-568-86	62756056886	60 TABLET, FOR SUSPENSION in 1 BOTTLE (62756-568-86)Marketed from Dec 2, 2019

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 — 125 mg/1
Dosage form: Tablet, For suspension
Route: Oral
Labeler: Sun Pharmaceutical Industries, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209782
Marketing start: Dec 2, 2019
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 62756-568_88009dbf-bf02-432b-95d4-27a6934590b8SPL ID 88009dbf-bf02-432b-95d4-27a6934590b8SPL set ID 4a2e1bd2-9f3a-40ec-94a2-bc76350d6d4bRxCUI 597768, 597770, 597772UNII V8G4MOF2V9UPC 0362756569836, 0362756570832
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

N462756056883 followed by a unit qualifier and the quantity

Package 62756-0568-83. 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 Dec 26, 2023. 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 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 (Transfusional I…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 209782

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

FDA NDC Directory listings under ANDA 209782
Product	Strength	Form · route	Labeler	Product NDC
deferasirox	Deferasirox 500 mg/1	Tablet, For suspensionOral	Sun Pharmaceutical Industries, Inc.	62756-570
deferasirox	Deferasirox 250 mg/1	Tablet, For suspensionOral	Sun Pharmaceutical Industries, Inc.	62756-569