Deferasirox Tablet, Film Coated
NDC Package 62332-412-91

11-digit billing NDC: 62332041291
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Deferasirox tablets are 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 tablets [see Warnings and Precautions (5.7), Adverse Reactions (6.2)]. This formulation utilizes a tablet, film coated delivery system. Marketed by Alembic Pharmaceuticals Inc., this product is identified by NDC 62332-412 and is authorized under FDA application ANDA211824.

Identification & Billing

NDC Package Code
62332-412-91
Package Description
1000 TABLET, FILM COATED in 1 BOTTLE
Product Code
62332-412
11-Digit Billing Format
62332041291
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Deferasirox
Non-Proprietary Name
Deferasirox
Substance Name
Deferasirox
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DEFERASIROX 360 mg/1
Pharmacologic Class
Usage Information
Deferasirox tablets are 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 tablets [see Warnings and Precautions (5.7), Adverse Reactions (6.2)].

Regulatory & Marketing

Labeler Name
Alembic Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA211824
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-21-2019
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (62332-412). Click a package code to view its specific billing and regulatory data.

62332-412-30
30 TABLET, FILM COATED in 1 BOTTLE

* 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 62332-412-91 identifies a specific commercial package of 1000 tablet, film coated in 1 bottle of Deferasirox, a human prescription drug labeled by Alembic Pharmaceuticals Inc.. This tablet, film coated 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 Alembic Pharmaceuticals Inc. on November 21, 2019. The current certification is valid through December 31, 2027.

How is this Alembic Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62332041291. 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)
62332-412-91
11-Digit CMS (5-4-2)
62332-0412-91

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