NDC Package 54458-866-10 Pioglitazone

View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

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

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

54458-866-10

Package Description:

30 TABLET in 1 BLISTER PACK

Product Code:

54458-866

Proprietary Name:

Pioglitazone

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)].

11-Digit NDC Billing Format:

54458086610

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

30 EA

NDC to RxNorm Crosswalk:

RxCUI: 312440 - pioglitazone 30 MG Oral Tablet

RxCUI: 312440 - pioglitazone (as pioglitazone hydrochloride) 30 MG Oral Tablet

RxCUI: 312441 - pioglitazone 45 MG Oral Tablet

RxCUI: 312441 - pioglitazone (as pioglitazone HCl) 45 MG Oral Tablet

RxCUI: 317573 - pioglitazone 15 MG Oral Tablet

Labeler Name:

International Laboratories, Llc

Sample Package:

Start Marketing Date:

05-01-2015

Listing Expiration Date:

12-31-2018

Exclude Flag:

Code Structure:

54458 - International Laboratories, Llc
- 54458-866 - Pioglitazone
  - 54458-866-10 - 30 TABLET in 1 BLISTER PACK

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 disclaimer below.

Frequently Asked Questions

What is NDC 54458-866-10?

The NDC Packaged Code 54458-866-10 is assigned to a package of 30 tablet in 1 blister pack of Pioglitazone, labeled by International Laboratories, Llc. The product's dosage form is and is administered via form.

Is NDC 54458-866 included in the NDC Directory?

No, Pioglitazone with product code 54458-866 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by International Laboratories, Llc on May 01, 2015 and its listing in the NDC Directory is set to expire on December 31, 2018 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 54458-866-10?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 30.

What is the 11-digit format for NDC 54458-866-10?

The 11-digit format is 54458086610. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	54458-866-10	5-4-2	54458-0866-10

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