Deferasirox NDC 69097-570

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-570Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0570Add 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
69097-570-53	69097057053	30 PACKET in 1 CARTON (69097-570-53) / 1 GRANULE in 1 PACKETMarketed from Feb 23, 2022

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 — 360 mg/1
Dosage form: Granule
Route: Oral
Labeler: Cipla USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215026
Marketing start: Feb 23, 2022
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 69097-570_ce7e02d0-319e-4a5b-87e1-c6550ab4322cSPL ID ce7e02d0-319e-4a5b-87e1-c6550ab4322cSPL set ID 31c5a91f-e901-418b-a519-779a0c245477RxCUI 1923822, 1923826, 1923828UNII V8G4MOF2V9UPC 0369097550530, 0369097560539, 0369097570538
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

N469097057053 followed by a unit qualifier and the quantity

Package 69097-0570-53. 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 Jul 8, 2021. This label includes a boxed warning.

Indications (excerpt from the label)

Deferasirox granule 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 granule 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 215026

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

FDA NDC Directory listings under ANDA 215026
Product	Strength	Form · route	Labeler	Product NDC
Deferasirox	Deferasirox 90 mg/1	GranuleOral	Cipla USA Inc.	69097-550
Deferasirox	Deferasirox 180 mg/1	GranuleOral	Cipla USA Inc.	69097-560