Oseni Tablet, Film Coated
NDC Package 64764-253-04

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

Oseni (alogliptin and pioglitazone) tablets is this combination medication is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. This formulation utilizes a tablet, film coated delivery system. Marketed by Takeda Pharmaceuticals America, Inc., this product is identified by NDC 64764-253 and is authorized under FDA application NDA022426.

Identification & Billing

NDC Package Code
64764-253-04
Package Description
90 TABLET, FILM COATED in 1 BOTTLE
Product Code
64764-253
11-Digit Billing Format
64764025304
RxNorm Crosswalk
  • RxCUI: 1368410 - alogliptin 12.5 MG / pioglitazone 30 MG Oral Tablet
  • RxCUI: 1368410 - alogliptin 12.5 MG (as alogliptin benzoate 17 MG) / pioglitazone 30 MG (as pioglitazone hydrochloride 33.06 MG) Oral Tablet
  • RxCUI: 1368416 - Oseni 12.5 MG / 30 MG Oral Tablet
  • RxCUI: 1368416 - alogliptin 12.5 MG / pioglitazone 30 MG Oral Tablet [Oseni]
  • RxCUI: 1368416 - Oseni 12.5/30 (as alogliptin benzoate 17 MG / pioglitazone hydrochloride 33.06 MG) Oral Tablet

Clinical Specifications

Proprietary Name
Oseni
Non-Proprietary Name
Alogliptin And Pioglitazone
Substance Name
Alogliptin Benzoate; Pioglitazone Hydrochloride
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)
Pharmacologic Class
Usage Information
This combination medication is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. This product contains 2 medications: alogliptin and pioglitazone. Alogliptin works by increasing levels of natural substances called incretins. Incretins help to control blood sugar by increasing insulin release, especially after a meal. They also decrease the amount of sugar your liver makes. Pioglitazone works by helping to restore your body's proper response to insulin.

Regulatory & Marketing

Labeler Name
Takeda Pharmaceuticals America, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA022426
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-25-2013
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 (64764-253). Click a package code to view its specific billing and regulatory data.

64764-253-03
30 TABLET, FILM COATED in 1 BOTTLE
64764-253-05
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 64764-253-04 identifies a specific commercial package of 90 tablet, film coated in 1 bottle of Oseni, a human prescription drug labeled by Takeda Pharmaceuticals America, Inc.. This tablet, film coated is formulated for oral use and contains alogliptin benzoate; pioglitazone hydrochloride 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 Takeda Pharmaceuticals America, Inc. on January 25, 2013. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This combination medication is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. This product contains 2 medications: alogliptin and pioglitazone. Alogliptin works by increasing levels of natural substances called incretins. Incretins help to control blood sugar by increasing insulin release, especially after a meal. They also decrease the amount of sugar your liver makes. Pioglitazone works by helping to restore your body's proper response to insulin.

How is this Takeda Pharmaceuticals America, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64764025304. 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)
64764-253-04
11-Digit CMS (5-4-2)
64764-0253-04

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