Pioglitazone And Metformin
NDC Package 70882-105-56

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Pioglitazone And Metformin is hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both pioglitazone and metformin is appropriate [see CLINICAL STUDIES (14)].Important Limitations of UsePioglitazone exerts its antihyperglycemic effect only in the presence of endogenous insulin. Marketed by Cambridge Therapeutics Technologies, Llc, this product is identified by NDC 70882-105 and is authorized under FDA application ANDA091273.

Identification & Billing

NDC Package Code
70882-105-56
Package Description
56 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
70882-105
11-Digit Billing Format
70882010556
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
56 EA
RxNorm Crosswalk
  • RxCUI: 861783 - pioglitazone 15 MG / metFORMIN HCl 500 MG Oral Tablet
  • RxCUI: 861783 - metformin hydrochloride 500 MG / pioglitazone 15 MG Oral Tablet

Clinical Specifications

Proprietary Name
Pioglitazone And Metformin
Dosage Form
-
Usage Information
Pioglitazone and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both pioglitazone and metformin is appropriate [see CLINICAL STUDIES (14)].Important Limitations of UsePioglitazone exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone and metformin hydrochloride tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings.Use caution in patients with liver disease [see WARNINGS AND PRECAUTIONS (5.5)].

Regulatory & Marketing

Labeler Name
Cambridge Therapeutics Technologies, Llc
FDA Application #
ANDA091273
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-02-2013
Listing Expiration
12-31-2018
Exclude Flag
I
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70882-105-56 identifies a specific commercial package of 56 tablet, film coated in 1 blister pack of Pioglitazone And Metformin, labeled by Cambridge Therapeutics Technologies, 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 Cambridge Therapeutics Technologies, Llc on May 02, 2013. The current certification is valid through December 31, 2018.

How is this Cambridge Therapeutics Technologies, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70882010556. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 56 total billable units per package. 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)
70882-105-56
11-Digit CMS (5-4-2)
70882-0105-56

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