Actoplus Met
NDC Package 64764-310-07

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.

Actoplus Met is this combination medication is used along with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Marketed by Takeda Pharmaceuticals America, Inc., this product is identified by NDC 64764-310 and is authorized under FDA application NDA022024.

Identification & Billing

NDC Package Code
64764-310-07
Package Description
1 BLISTER PACK in 1 CARTON / 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
64764-310
11-Digit Billing Format
64764031007

Clinical Specifications

Proprietary Name
Actoplus Met XR
Dosage Form
-
Usage Information
This combination medication is used along 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. Pioglitazone belongs to a class of drugs known as thiazolidinediones or "glitazones". Metformin and pioglitazone work by helping to restore your body's proper response to the insulin you naturally produce. Metformin also decreases the amount of sugar that your liver makes and that your stomach/intestines absorb. Talk to your doctor about the risks and benefits of using pioglitazone-containing products.

Regulatory & Marketing

Labeler Name
Takeda Pharmaceuticals America, Inc.
FDA Application #
NDA022024
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-11-2010
End Marketing Date
09-30-2022
Listing Expiration
09-30-2022
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 (64764-310). Click a package code to view its specific billing and regulatory data.

64764-310-30
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
64764-310-33
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
64764-310-60
60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
64764-310-90
90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

* 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 64764-310-07 identifies a specific commercial package of 1 blister pack in 1 carton / 7 tablet, film coated, extended release in 1 blister pack of Actoplus Met XR, labeled by Takeda Pharmaceuticals America, Inc.. 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 Takeda Pharmaceuticals America, Inc. on June 11, 2010. The current certification is valid through September 30, 2022.

What are the primary indications for this medication?

This combination medication is used along 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. Pioglitazone belongs to a class of drugs known as thiazolidinediones or "glitazones". Metformin and pioglitazone work by helping to restore your body's proper response to the insulin you naturally produce. Metformin also decreases the amount of sugar that your liver makes and that your stomach/intestines absorb. Talk to your doctor about the risks and benefits of using pioglitazone-containing products.

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: 64764031007. 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)
64764-310-07
11-Digit CMS (5-4-2)
64764-0310-07

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