Pioglitazone Hydrochloride
NDC Package 71335-2082-2

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

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 UsePioglitazone tablets exert their antihyperglycemic effect only in the presence of endogenous insulin. Marketed by Bryant Ranch Prepack, this product is identified by NDC 71335-2082 and is authorized under FDA application ANDA076798.

Identification & Billing

NDC Package Code
71335-2082-2
Package Description
60 TABLET in 1 BOTTLE
Product Code
71335-2082
11-Digit Billing Format
71335208202
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 UsePioglitazone tablets exert their 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
Bryant Ranch Prepack
FDA Application #
ANDA076798
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-28-2020
End Marketing Date
01-01-2024
Listing Expiration
01-01-2024
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 (71335-2082). Click a package code to view its specific billing and regulatory data.

71335-2082-1
30 TABLET in 1 BOTTLE
71335-2082-3
90 TABLET in 1 BOTTLE
71335-2082-4
180 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 71335-2082-2 identifies a specific commercial package of 60 tablet in 1 bottle of Pioglitazone Hydrochloride, labeled by Bryant Ranch Prepack. 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 Bryant Ranch Prepack on October 28, 2020. The current certification is valid through January 01, 2024.

How is this Bryant Ranch Prepack product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71335208202. 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)
71335-2082-2
11-Digit CMS (5-4-2)
71335-2082-02

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