NDC Package 70771-1021-9 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:
70771-1021-9
Package Description:
90 TABLET in 1 BOTTLE
Product Code:
Proprietary Name:
Pioglitazone
Non-Proprietary Name:
Pioglitazone
Substance Name:
Pioglitazone Hydrochloride
Usage Information:
Monotherapy and Combination TherapyPioglitazone tablets, USP 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 hydrochloride exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone hydrochloride 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:
70771102109
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
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Zydus Lifesciences Limited
    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:
    ANDA202456
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-16-2016
    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
    70771-1021-01000 TABLET in 1 BOTTLE
    70771-1021-1100 TABLET in 1 BOTTLE
    70771-1021-330 TABLET in 1 BOTTLE
    70771-1021-410 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK
    70771-1021-5500 TABLET in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 70771-1021-9?

    The NDC Packaged Code 70771-1021-9 is assigned to a package of 90 tablet in 1 bottle of Pioglitazone, a human prescription drug labeled by Zydus Lifesciences Limited. The product's dosage form is tablet and is administered via oral form.

    Is NDC 70771-1021 included in the NDC Directory?

    Yes, Pioglitazone with product code 70771-1021 is active and included in the NDC Directory. The product was first marketed by Zydus Lifesciences Limited on November 16, 2016 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 70771-1021-9?

    The 11-digit format is 70771102109. 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
    5-4-170771-1021-95-4-270771-1021-09