Deferasorox Granule
NDC Package 72205-075-30

11-digit billing NDC: 72205007530 · Billing unit: EA · 30 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Deferasorox (deferasirox) granules is deferasirox is contraindicated in patients with: Estimated GFR less than 40 mL/min/1.73 m2 [see Dosage and Administration (2.5), Warnings and Precautions (5.1)];Poor performance status [see Warnings and Precautions (5.1, 5.3)]; High-risk myelodysplastic syndromes (this patient population was not studied and is not expected to benefit from chelation therapy); Advanced malignancies [see Warnings and Precautions (5.1, 5.3)];Platelet counts less than 50 x 109/L [see Warnings and Precautions (5.3, 5.4)];Known hypersensitivity to deferasirox or any component of deferasirox [see Warnings and Precautions (5.7), Adverse Reactions (6.2)]. This formulation utilizes a granule delivery system. Marketed by Novadoz Pharmaceuticals Llc, this product is identified by NDC 72205-075 and is authorized under FDA application ANDA214650.

Identification & Billing

NDC Package Code
72205-075-30
Package Description
30 PACKET in 1 CARTON / 1 GRANULE in 1 PACKET (72205-075-61)
Product Code
72205-075
11-Digit Billing Format
72205007530
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Deferasorox
Non-Proprietary Name
Deferasirox
Substance Name
Deferasirox
Dosage Form
Granule - A small particle or grain.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DEFERASIROX 180 mg/1
Pharmacologic Class
Usage Information
Deferasirox is contraindicated in patients with: Estimated GFR less than 40 mL/min/1.73 m2 [see Dosage and Administration (2.5), Warnings and Precautions (5.1)];Poor performance status [see Warnings and Precautions (5.1, 5.3)]; High-risk myelodysplastic syndromes (this patient population was not studied and is not expected to benefit from chelation therapy); Advanced malignancies [see Warnings and Precautions (5.1, 5.3)];Platelet counts less than 50 x 109/L [see Warnings and Precautions (5.3, 5.4)];Known hypersensitivity to deferasirox or any component of deferasirox [see Warnings and Precautions (5.7), Adverse Reactions (6.2)].

Regulatory & Marketing

Labeler Name
Novadoz Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA214650
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-18-2021
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 72205-075-30 identifies a specific commercial package of 30 packet in 1 carton / 1 granule in 1 packet (72205-075-61) of Deferasorox, a human prescription drug labeled by Novadoz Pharmaceuticals Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This granule is formulated for oral use and contains deferasirox as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Novadoz Pharmaceuticals Llc on March 18, 2021. The current certification is valid through December 31, 2027.

How is this Novadoz Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72205007530. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
72205-075-30
11-Digit CMS (5-4-2)
72205-0075-30

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.