Saxagliptin
NDC Package 65162-059-09

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

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Saxagliptin is a . Marketed by Amneal Pharmaceuticals Llc, this product is identified by NDC 65162-059 and is authorized under FDA application ANDA205941.

Identification & Billing

NDC Package Code
65162-059-09
Package Description
90 TABLET, FILM COATED in 1 BOTTLE
Product Code
65162-059
11-Digit Billing Format
65162005909

Clinical Specifications

Proprietary Name
Saxagliptin
Dosage Form
-

Regulatory & Marketing

Labeler Name
Amneal Pharmaceuticals Llc
FDA Application #
ANDA205941
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-01-2023
End Marketing Date
01-14-2026
Listing Expiration
01-14-2026
Exclude Flag
D
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 (65162-059). Click a package code to view its specific billing and regulatory data.

65162-059-03
30 TABLET, FILM COATED in 1 BOTTLE
65162-059-50
500 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 65162-059-09 identifies a specific commercial package of 90 tablet, film coated in 1 bottle of Saxagliptin, labeled by Amneal Pharmaceuticals Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Amneal Pharmaceuticals Llc on August 01, 2023. The current certification is valid through January 14, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65162005909. 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)
65162-059-09
11-Digit CMS (5-4-2)
65162-0059-09

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