Prescription drug · ANDA

Deferasirox NDC 69539-022

Deferasirox 250 mg/1 · Tablet, For suspension · Oral · MSN LABORATORIES PRIVATE LIMITED

NDC codes

FDA NDC Directory
Product NDC (as listed)69539-022Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69539-0022Add 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
69539-022-066953900220610 BLISTER PACK in 1 CARTON (69539-022-06) / 10 TABLET, FOR SUSPENSION in 1 BLISTER PACK (69539-022-11)Marketed from Feb 12, 2020
69539-022-306953900223030 TABLET, FOR SUSPENSION in 1 BOTTLE (69539-022-30)Marketed from Nov 20, 2019
69539-022-906953900229090 TABLET, FOR SUSPENSION in 1 BOTTLE (69539-022-90)Marketed from Nov 20, 2019
69539-022-99695390022991000 TABLET, FOR SUSPENSION in 1 BOTTLE (69539-022-99)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 — 250 mg/1
Dosage form
Tablet, For suspension
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209878
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 69539-022_4b237031-5375-4a5a-8a5d-21527f6fc7daSPL ID 4b237031-5375-4a5a-8a5d-21527f6fc7daSPL set ID e0726c9c-cee8-4fc1-abd1-68ad0db030ddRxCUI 597768, 597770, 597772UNII V8G4MOF2V9UPC 0369539022113, 0369539021994, 0369539021901, 0369539021307, 0369539023110, 0369539022908, 0369539023301, 0369539022991, 0369539023059, 0369539023905, 0369539022304
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

N469539002206 followed by a unit qualifier and the quantity

Package 69539-0022-06. 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 when administered with other iron chelation therapy have not been established. ( 1.3 ) 1.1 Treatment of Chronic Iron…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 209878

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

FDA NDC Directory listings under ANDA 209878
ProductStrengthForm · routeLabelerProduct NDC
DeferasiroxDeferasirox 125 mg/1Tablet, For suspensionOralMSN LABORATORIES PRIVATE LIMITED69539-021
DeferasiroxDeferasirox 500 mg/1Tablet, For suspensionOralMSN LABORATORIES PRIVATE LIMITED69539-023
DeferasiroxDeferasirox 250 mg/1Tablet, For suspensionOralDr. Reddy's Laboratories Inc43598-856
DeferasiroxDeferasirox 250 mg/1Tablet, For suspensionOralNovadoz Pharmaceuticals LLC72205-390
DeferasiroxDeferasirox 125 mg/1Tablet, For suspensionOralNovadoz Pharmaceuticals LLC72205-389
DeferasiroxDeferasirox 125 mg/1Tablet, For suspensionOralDr. Reddy's Laboratories Inc43598-855
DeferasiroxDeferasirox 500 mg/1Tablet, For suspensionOralDr. Reddy's Laboratories Inc43598-854
DeferasiroxDeferasirox 500 mg/1Tablet, For suspensionOralNovadoz Pharmaceuticals LLC72205-391

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Deferasirox NDC 69539-022 | Med-Code