NDC codes

FDA NDC Directory
Product NDC (as listed)0480-7013Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00480-7013Add 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
0480-7013-56004807013560048070135630 TABLET, FOR SUSPENSION in 1 BOTTLE (0480-7013-56)Marketed from Nov 1, 2024

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 500 mg/1
Dosage form
Tablet, For suspension
Route
Oral
Labeler
Teva Pharmaceuticals, Inc.NDC labeler code 0480
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207124
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 0480-7013_c6658799-331b-4e3e-9fa6-e8642cf4c9d6SPL ID c6658799-331b-4e3e-9fa6-e8642cf4c9d6SPL set ID e9054806-2721-4736-9aef-81ffb8db75d1RxCUI 597768, 597770, 597772UNII 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

N400480701356 followed by a unit qualifier and the quantity

Package 00480-7013-56. 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 for oral suspension 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 for oral suspension 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 and a serum ferritin greater than 300 mcg/L. (1.2) Limitations of Use: The safety and efficacy of deferasirox tablets for oral suspension when administered with other iron chelation therapy have not been established. (1.3) 1.1 Tre…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0480-7013

What is NDC 0480-7013?
0480-7013 is the product NDC for Deferasirox, Deferasirox 500 mg/1 tablet, for suspension, listed with the FDA by Teva Pharmaceuticals, Inc.. It has 1 package NDC, 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?
Teva Pharmaceuticals, Inc., NDC labeler code 0480. 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 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
DeferasiroxDeferasirox 360 mg/1Tablet, Film coatedOralNorthStar Rx LLC72603-23372603-0233-01

All 76 Deferasirox NDCs

Other NDCs under ANDA 207124

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

FDA NDC Directory listings under ANDA 207124
ProductStrengthForm · routeLabelerProduct NDC
DeferasiroxDeferasirox 125 mg/1Tablet, For suspensionOralTeva Pharmaceuticals, Inc.0480-7011
DeferasiroxDeferasirox 250 mg/1Tablet, For suspensionOralTeva Pharmaceuticals, Inc.0480-7012

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