Dasatinib Tablet, Film Coated
NDC Package 46708-684-60

11-digit billing NDC: 46708068460
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Dasatinib tablets is dasatinib tablet is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib.Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.Dasatinib tablet is indicated for the treatment of pediatric patients 1 year of age and older with• Ph+ CML in chronic phase.Additional pediatric use information is approved for Bristol-Myers Squibb Company’s Sprycel (dasatinib) tablets. This formulation utilizes a tablet, film coated delivery system. Marketed by Alembic Pharmaceuticals Limited, this product is identified by NDC 46708-684 and is authorized under FDA application ANDA216261.

Identification & Billing

NDC Package Code
46708-684-60
Package Description
60 TABLET, FILM COATED in 1 BOTTLE
Product Code
46708-684
11-Digit Billing Format
46708068460
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dasatinib
Non-Proprietary Name
Dasatinib
Substance Name
Dasatinib
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)
DASATINIB 20 mg/1
Pharmacologic Class
Usage Information
Dasatinib tablet is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib.Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.Dasatinib tablet is indicated for the treatment of pediatric patients 1 year of age and older with• Ph+ CML in chronic phase.Additional pediatric use information is approved for Bristol-Myers Squibb Company’s Sprycel (dasatinib) tablets. However, due to Bristol-Myers Squibb Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Regulatory & Marketing

Labeler Name
Alembic Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA216261
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-11-2025
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 46708-684-60 identifies a specific commercial package of 60 tablet, film coated in 1 bottle of Dasatinib, a human prescription drug labeled by Alembic Pharmaceuticals Limited. This tablet, film coated is formulated for oral use and contains dasatinib 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 Limited on November 11, 2025. The current certification is valid through December 31, 2026.

How is this Alembic Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46708068460. 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)
46708-684-60
11-Digit CMS (5-4-2)
46708-0684-60

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