Alogliptin Benzoate Powder
NDC Package 14445-016-01

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Alogliptin Benzoate powders is alogliptin is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. This formulation utilizes a powder delivery system. Marketed by Indoco Remedies Limited, this product is identified by NDC 14445-016.

Identification & Billing

NDC Package Code
14445-016-01
Package Description
5 kg in 1 DRUM
Product Code
14445-016
11-Digit Billing Format
14445001601

Clinical Specifications

Proprietary Name
Alogliptin Benzoate
Non-Proprietary Name
Alogliptin Benzoate
Substance Name
Alogliptin Benzoate
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
ALOGLIPTIN BENZOATE 1 kg/kg
Usage Information
Alogliptin 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. 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.

Regulatory & Marketing

Labeler Name
Indoco Remedies Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
06-30-2016
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 (14445-016). Click a package code to view its specific billing and regulatory data.

14445-016-02
10 kg in 1 DRUM
14445-016-03
25 kg in 1 DRUM

* 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 14445-016-01 identifies a specific commercial package of 5 kg in 1 drum of Alogliptin Benzoate (UNFINISHED drug), a bulk ingredient labeled by Indoco Remedies Limited. This powder is formulated for use and contains alogliptin benzoate 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 Indoco Remedies Limited on June 30, 2016. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Alogliptin 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. 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.

How is this Indoco Remedies Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 14445001601. 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)
14445-016-01
11-Digit CMS (5-4-2)
14445-0016-01

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