What is NDC 68462-495?

68462-495 is the product NDC for deferasirox, Deferasirox 250 mg/1 tablet, for suspension, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 1 package NDC, shown above in 10- and 11-digit form.

Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. 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?

77 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

deferasirox NDC 68462-495 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68462-495Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68462-0495Add 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
68462-495-90	68462049590	90 TABLET, FOR SUSPENSION in 1 BOTTLE (68462-495-90)Marketed from Jan 6, 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 — 250 mg/1
Dosage form: Tablet, For suspension
Route: Oral
Labeler: Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209433
Marketing start: Jan 6, 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 68462-495_e2349a09-1e53-462c-b185-225ca0a400a4SPL ID e2349a09-1e53-462c-b185-225ca0a400a4SPL set ID 59f1d3fb-5bdb-4261-8557-9a4bde8b3c1cRxCUI 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

N468462049590 followed by a unit qualifier and the quantity

Package 68462-0495-90. 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 Nov 26, 2024. 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 when administered with other iron chelation therapy have not been established. ( 1.3 ) 1.1 Treatment of Chronic Iron O…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68462-495

What is NDC 68462-495?: 68462-495 is the product NDC for deferasirox, Deferasirox 250 mg/1 tablet, for suspension, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. 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?: Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. 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?: 77 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Deferasirox	Deferasirox 360 mg/1	TabletOral	AvKARE	73190-052	73190-0052-30
Deferasirox	Deferasirox 180 mg/1	GranuleOral	Aurobindo Pharma Limited	59651-448	59651-0448-30
Deferasirox	Deferasirox 90 mg/1	GranuleOral	Aurobindo Pharma Limited	59651-447	59651-0447-30
Deferasirox	Deferasirox 360 mg/1	GranuleOral	Aurobindo Pharma Limited	59651-449	59651-0449-30
Deferasirox	Deferasirox 125 mg/1	Tablet, For suspensionOral	Teva Pharmaceuticals, Inc.	0480-7011	00480-7011-56
Deferasirox	Deferasirox 250 mg/1	Tablet, For suspensionOral	Teva Pharmaceuticals, Inc.	0480-7012	00480-7012-56
Deferasirox	Deferasirox 500 mg/1	Tablet, For suspensionOral	Teva Pharmaceuticals, Inc.	0480-7013	00480-7013-56
Deferasirox	Deferasirox 180 mg/1	Tablet, Film coatedOral	NorthStar Rx LLC	72603-232	72603-0232-01
Deferasirox	Deferasirox 90 mg/1	Tablet, Film coatedOral	NorthStar Rx LLC	72603-231	72603-0231-01
Deferasirox	Deferasirox 360 mg/1	Tablet, Film coatedOral	NorthStar Rx LLC	72603-233	72603-0233-01

All 78 deferasirox NDCs

Other NDCs under ANDA 209433

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

FDA NDC Directory listings under ANDA 209433
Product	Strength	Form · route	Labeler	Product NDC
deferasirox	Deferasirox 125 mg/1	Tablet, For suspensionOral	Glenmark Pharmaceuticals Inc., USA	68462-494
deferasirox	Deferasirox 500 mg/1	Tablet, For suspensionOral	Glenmark Pharmaceuticals Inc., USA	68462-496