Pioglitazone Hydrochloride
NDC Package 71610-497-30

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 inactivated by the FDA.

Pioglitazone Hydrochloride is monotherapy and Combination TherapyPioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)].Important Limitations of Use Pioglitazone tablets exert its antihyperglycemic effect only in the presence of endogenous insulin. Marketed by Aphena Pharma Solutions - Tennessee, Llc, this product is identified by NDC 71610-497 and is authorized under FDA application ANDA200268.

Identification & Billing

NDC Package Code
71610-497-30
Package Description
30 TABLET in 1 BOTTLE
Product Code
71610-497
11-Digit Billing Format
71610049730
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Pioglitazone Hydrochloride
Dosage Form
-
Usage Information
Monotherapy and Combination TherapyPioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)].Important Limitations of Use Pioglitazone tablets exert its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone 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 (5.3)].

Regulatory & Marketing

Labeler Name
Aphena Pharma Solutions - Tennessee, Llc
FDA Application #
ANDA200268
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-13-2013
Listing Expiration
12-31-2022
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (71610-497). Click a package code to view its specific billing and regulatory data.

71610-497-60
90 TABLET 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 71610-497-30 identifies a specific commercial package of 30 tablet in 1 bottle of Pioglitazone Hydrochloride, labeled by Aphena Pharma Solutions - Tennessee, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. 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 Aphena Pharma Solutions - Tennessee, Llc on February 13, 2013. The current certification is valid through December 31, 2022.

How is this Aphena Pharma Solutions - Tennessee, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71610049730. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
71610-497-30
11-Digit CMS (5-4-2)
71610-0497-30

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