Pioglitazone
NDC Package 54458-883-10

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 discontinued by the firm.

Pioglitazone is do not initiate in patients with NYHA Class III or IV heart failure [see Boxed Warning].Do not use in patients with a history of a serious hypersensitivity reaction to pioglitazone tablets or any of their ingredients. Marketed by International Laboratories, Llc, this product is identified by NDC 54458-883 and is authorized under FDA application NDA021073.

Identification & Billing

NDC Package Code
54458-883-10
Package Description
30 TABLET in 1 BLISTER PACK
Product Code
54458-883
11-Digit Billing Format
54458088310
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Pioglitazone
Dosage Form
-
Usage Information
Do not initiate in patients with NYHA Class III or IV heart failure [see Boxed Warning].Do not use in patients with a history of a serious hypersensitivity reaction to pioglitazone tablets or any of their ingredients.

Regulatory & Marketing

Labeler Name
International Laboratories, Llc
FDA Application #
NDA021073
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
12-08-2013
End Marketing Date
05-24-2017
Listing Expiration
05-24-2017
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 54458-883-10 identifies a specific commercial package of 30 tablet in 1 blister pack of Pioglitazone, labeled by International Laboratories, 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 International Laboratories, Llc on December 08, 2013. The current certification is valid through May 24, 2017.

How is this International Laboratories, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54458088310. 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)
54458-883-10
11-Digit CMS (5-4-2)
54458-0883-10

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