NDC Package 0781-5635-10 Pioglitazone Hydrochloride And Glimepiride

View Billable Units, 11-Digit Format, RxNorm

Package Information

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

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:
0781-5635-10
Package Description:
1000 TABLET in 1 BOTTLE
Product Code:
Proprietary Name:
Pioglitazone Hydrochloride And Glimepiride
Usage Information:
Pioglitazone and glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a thiazolidinedione and sulfonylurea or who have inadequate glycemic control on a thiazolidinedione alone or a sulfonylurea alone [see Clinical Studies (14)].Important Limitations of UsePioglitazone exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone and glimepiride 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 (5.5)].
11-Digit NDC Billing Format:
00781563510
Labeler Name:
Sandoz Inc
Sample Package:
No
FDA Application Number:
ANDA201049
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
01-08-2013
End Marketing Date:
05-31-2018
Listing Expiration Date:
05-31-2018
Exclude Flag:
D
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.

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Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
0781-5635-3130 TABLET in 1 BOTTLE

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Frequently Asked Questions

What is NDC 0781-5635-10?

The NDC Packaged Code 0781-5635-10 is assigned to a package of 1000 tablet in 1 bottle of Pioglitazone Hydrochloride And Glimepiride, labeled by Sandoz Inc. The product's dosage form is and is administered via form.

Is NDC 0781-5635 included in the NDC Directory?

No, Pioglitazone Hydrochloride And Glimepiride with product code 0781-5635 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Sandoz Inc on January 08, 2013 and its listing in the NDC Directory is set to expire on May 31, 2018 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 0781-5635-10?

The 11-digit format is 00781563510. 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 4-4-2 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 Format10-Digit Original Code11-Digit Format11-Digit Code
4-4-20781-5635-105-4-200781-5635-10