Sitagliptin Phosphate Powder
NDC Package 12666-0013-2

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.

Sitagliptin Phosphate powders is sitagliptin is used with a proper diet and exercise program and possibly with other medications to control high blood sugar. This formulation utilizes a powder delivery system. Marketed by Zhejiang Apeloa Jiayuan Pharmaceutical Co., Ltd., this product is identified by NDC 12666-0013.

Identification & Billing

NDC Package Code
12666-0013-2
Package Description
20 kg in 1 DRUM
Product Code
12666-0013
11-Digit Billing Format
12666001302

Clinical Specifications

Proprietary Name
Sitagliptin Phosphate
Non-Proprietary Name
Sitagliptin Phosphate
Substance Name
Sitagliptin Phosphate
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)
SITAGLIPTIN PHOSPHATE 1 kg/kg
Usage Information
Sitagliptin is used with a proper diet and exercise program and possibly with other medications to control high blood sugar. It is used 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. Sitagliptin is a diabetes drug that 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
Zhejiang Apeloa Jiayuan Pharmaceutical Co., Ltd.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
05-10-2010
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 (12666-0013). Click a package code to view its specific billing and regulatory data.

12666-0013-1
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 12666-0013-2 identifies a specific commercial package of 20 kg in 1 drum of Sitagliptin Phosphate (UNFINISHED drug), a bulk ingredient labeled by Zhejiang Apeloa Jiayuan Pharmaceutical Co., Ltd.. This powder is formulated for use and contains sitagliptin phosphate 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 Zhejiang Apeloa Jiayuan Pharmaceutical Co., Ltd. on May 10, 2010. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Sitagliptin is used with a proper diet and exercise program and possibly with other medications to control high blood sugar. It is used 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. Sitagliptin is a diabetes drug that 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 Zhejiang Apeloa Jiayuan Pharmaceutical Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 12666001302. 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 (5-4-1)
12666-0013-2
11-Digit CMS (5-4-2)
12666-0013-02

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