Cladribine Tablet
NDC Package 62049-286-04

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Cladribine tablets is cladribine is used to treat a certain type of cancer (hairy cell leukemia). This formulation utilizes a tablet delivery system. Marketed by Genvion Corporation, this product is identified by NDC 62049-286 and is authorized under FDA application ANDA218425.

Identification & Billing

NDC Package Code
62049-286-04
Package Description
4 TABLET in 1 CARTON
Product Code
62049-286
11-Digit Billing Format
62049028604
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cladribine
Non-Proprietary Name
Cladribine
Substance Name
Cladribine
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CLADRIBINE 10 mg/1
Pharmacologic Class
Purine Antimetabolite - [EPC] (Established Pharmacologic Class)
Usage Information
Cladribine is used to treat a certain type of cancer (hairy cell leukemia). It works by stopping the growth of cancer cells.

Regulatory & Marketing

Labeler Name
Genvion Corporation
Product Type
Human Prescription Drug
FDA Application #
ANDA218425
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-25-2025
Listing Expiration
12-31-2026
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 (62049-286). Click a package code to view its specific billing and regulatory data.

62049-286-05
5 TABLET in 1 CARTON
62049-286-06
6 TABLET in 1 CARTON
62049-286-07
7 TABLET in 1 CARTON
62049-286-08
8 TABLET in 1 CARTON
62049-286-09
9 TABLET in 1 CARTON
62049-286-10
10 TABLET in 1 CARTON

* 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 62049-286-04 identifies a specific commercial package of 4 tablet in 1 carton of Cladribine, a human prescription drug labeled by Genvion Corporation. This tablet is formulated for oral use and contains cladribine 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 Genvion Corporation on November 25, 2025. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Cladribine is used to treat a certain type of cancer (hairy cell leukemia). It works by stopping the growth of cancer cells.

How is this Genvion Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62049028604. 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)
62049-286-04
11-Digit CMS (5-4-2)
62049-0286-04

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