What is NDC 69539-075?

69539-075 is the product NDC for Deferasirox, Deferasirox 360 mg/1 tablet, listed with the FDA by MSN LABORATORIES PRIVATE LIMITED. It has 2 package NDCs, shown above in 10- and 11-digit form.

MSN LABORATORIES PRIVATE LIMITED, NDC labeler code 69539. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Deferasirox NDC 69539-075 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69539-075Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69539-0075Add 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
69539-075-30	6953900753069539007530	30 TABLET in 1 BOTTLE (69539-075-30)Marketed from Nov 20, 2019
69539-075-99	6953900759969539007599	1000 TABLET in 1 BOTTLE (69539-075-99)Marketed from Nov 20, 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 — 360 mg/1
Dosage form: Tablet
Route: Oral
Labeler: MSN LABORATORIES PRIVATE LIMITEDNDC labeler code 69539
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210945
Marketing start: Nov 20, 2019
Listing expires: Dec 31, 2027
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 69539-075_da168049-e499-4563-afe8-82ae754ed640SPL ID da168049-e499-4563-afe8-82ae754ed640SPL set ID 0354cbc7-9b32-4513-976a-2ef2da39b6b3RxCUI 1607784, 1607792, 1607796UNII V8G4MOF2V9UPC 0369539074303, 0369539075997, 0369539074990, 0369539073993, 0369539075300, 0369539073306
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

N469539007530 followed by a unit qualifier and the quantity

Package 69539-0075-30. 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 Jan 8, 2021. 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 69539-075

What is NDC 69539-075?: 69539-075 is the product NDC for Deferasirox, Deferasirox 360 mg/1 tablet, listed with the FDA by MSN LABORATORIES PRIVATE LIMITED. 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?: MSN LABORATORIES PRIVATE LIMITED, NDC labeler code 69539. 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
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 90 mg/1	GranuleOral	Aurobindo Pharma Limited	59651-447	59651-0447-30
Deferasirox	Deferasirox 180 mg/1	GranuleOral	Aurobindo Pharma Limited	59651-448	59651-0448-30
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 360 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-412	59651-0412-30
Deferasirox	Deferasirox 90 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-410	59651-0410-30
Deferasirox	Deferasirox 180 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-411	59651-0411-30

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
Product	Strength	Form · route	Labeler	Product NDC
Deferasirox	Deferasirox 360 mg/1	TabletOral	Dr. Reddy's Laboratories Inc	43598-851
Deferasirox	Deferasirox 180 mg/1	TabletOral	Dr. Reddy's Laboratories Inc	43598-852
Deferasirox	Deferasirox 90 mg/1	TabletOral	Dr. Reddy's Laboratories Inc	43598-853
Deferasirox	Deferasirox 90 mg/1	TabletOral	MSN LABORATORIES PRIVATE LIMITED	69539-073
Deferasirox	Deferasirox 180 mg/1	TabletOral	MSN LABORATORIES PRIVATE LIMITED	69539-074
Deferasirox	Deferasirox 360 mg/1	TabletOral	AvKARE	73190-052