NDC codes

FDA NDC Directory
Product NDC (as listed)43598-852Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43598-0852Add 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
43598-852-1043598085210435980852101000 TABLET in 1 BOTTLE (43598-852-10)Marketed from Jun 25, 2020
43598-852-30435980852304359808523030 TABLET in 1 BOTTLE (43598-852-30)Marketed from Jun 25, 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
Route
Oral
Labeler
Dr. Reddy's Laboratories IncNDC labeler code 43598
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210945
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 43598-852_95a20658-492c-6693-491b-f651f3a2f25fSPL ID 95a20658-492c-6693-491b-f651f3a2f25fSPL set ID 350dfc39-d03d-e221-22e9-3880728c955cRxCUI 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

N443598085210 followed by a unit qualifier and the quantity

Package 43598-0852-10. 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 are 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 are 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 T…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43598-852

What is NDC 43598-852?
43598-852 is the product NDC for Deferasirox, Deferasirox 180 mg/1 tablet, listed with the FDA by Dr. Reddy's Laboratories Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Deferasirox.
What is the active ingredient?
Deferasirox.
Who is the labeler?
Dr. Reddy's Laboratories Inc, NDC labeler code 43598. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Deferasirox?
75 other product NDCs are listed under this name. See all Deferasirox 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 Deferasirox NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
DeferasiroxDeferasirox 360 mg/1TabletOralAvKARE73190-05273190-0052-30
DeferasiroxDeferasirox 90 mg/1GranuleOralAurobindo Pharma Limited59651-44759651-0447-30
DeferasiroxDeferasirox 180 mg/1GranuleOralAurobindo Pharma Limited59651-44859651-0448-30
DeferasiroxDeferasirox 360 mg/1GranuleOralAurobindo Pharma Limited59651-44959651-0449-30
DeferasiroxDeferasirox 125 mg/1Tablet, For suspensionOralTeva Pharmaceuticals, Inc.0480-701100480-7011-56
DeferasiroxDeferasirox 250 mg/1Tablet, For suspensionOralTeva Pharmaceuticals, Inc.0480-701200480-7012-56
DeferasiroxDeferasirox 500 mg/1Tablet, For suspensionOralTeva Pharmaceuticals, Inc.0480-701300480-7013-56
DeferasiroxDeferasirox 360 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-41259651-0412-30
DeferasiroxDeferasirox 90 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-41059651-0410-30
DeferasiroxDeferasirox 180 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-41159651-0411-30

All 76 Deferasirox NDCs

Other NDCs under ANDA 210945

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

FDA NDC Directory listings under ANDA 210945
ProductStrengthForm · routeLabelerProduct NDC
DeferasiroxDeferasirox 360 mg/1TabletOralDr. Reddy's Laboratories Inc43598-851
DeferasiroxDeferasirox 90 mg/1TabletOralDr. Reddy's Laboratories Inc43598-853
DeferasiroxDeferasirox 90 mg/1TabletOralMSN LABORATORIES PRIVATE LIMITED69539-073
DeferasiroxDeferasirox 180 mg/1TabletOralMSN LABORATORIES PRIVATE LIMITED69539-074
DeferasiroxDeferasirox 360 mg/1TabletOralMSN LABORATORIES PRIVATE LIMITED69539-075
DeferasiroxDeferasirox 360 mg/1TabletOralAvKARE73190-052

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