NDC Package 53002-2757-3 Pioglitazone

Tablet Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information

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:
53002-2757-3
Package Description:
30 TABLET in 1 BOTTLE
Product Code:
Proprietary Name:
Pioglitazone
Non-Proprietary Name:
Pioglitazone
Substance Name:
Pioglitazone Hydrochloride
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:
53002275703
NDC to RxNorm Crosswalk:
  • RxCUI: 312441 - pioglitazone 45 MG Oral Tablet
  • RxCUI: 312441 - pioglitazone (as pioglitazone HCl) 45 MG Oral Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Rpk Pharmaceuticals, Inc.
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Sample Package:
    No
    FDA Application Number:
    ANDA077210
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-22-2015
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    53002-2757-990 TABLET in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 53002-2757-3?

    The NDC Packaged Code 53002-2757-3 is assigned to a package of 30 tablet in 1 bottle of Pioglitazone, a human prescription drug labeled by Rpk Pharmaceuticals, Inc.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 53002-2757 included in the NDC Directory?

    Yes, Pioglitazone with product code 53002-2757 is active and included in the NDC Directory. The product was first marketed by Rpk Pharmaceuticals, Inc. on May 22, 2015 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 53002-2757-3?

    The 11-digit format is 53002275703. 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 5-4-1 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    5-4-153002-2757-35-4-253002-2757-03