NDC Package 64376-601-31 Glycopyrrolate

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Package Information
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Package Information

This product is EXCLUDED from the official NDC directory .

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:

64376-601-31

Package Description:

30 TABLET in 1 BOTTLE

Product Code:

64376-601

Proprietary Name:

Glycopyrrolate

Usage Information:

Glycopyrrolate is used with other drugs to treat a certain type of stomach/intestinal ulcer (peptic ulcer). This medication may help relieve stomach/abdominal pain. However, it has not been shown to be effective in healing these ulcers, preventing them from returning, or preventing other problems caused by ulcers. Glycopyrrolate works by decreasing the amount of acid in the stomach. It also slows the natural movements of the gut and relaxes the muscles in the stomach/intestines. Glycopyrrolate belongs to a class of drugs known as anticholinergics.

11-Digit NDC Billing Format:

64376060131

Labeler Name:

Boca Pharmacal, Llc

Sample Package:

FDA Application Number:

ANDA090020

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

10-19-2011

End Marketing Date:

12-02-2013

Listing Expiration Date:

12-02-2013

Exclude Flag:

Code Structure:

64376 - Boca Pharmacal, Llc
- 64376-601 - Glycopyrrolate
  - 64376-601-31 - 30 TABLET in 1 BOTTLE

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 Code	Package Description
64376-601-01	100 TABLET in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 64376-601-31?

The NDC Packaged Code 64376-601-31 is assigned to a package of 30 tablet in 1 bottle of Glycopyrrolate, labeled by Boca Pharmacal, Llc. The product's dosage form is and is administered via form.

Is NDC 64376-601 included in the NDC Directory?

The product was first marketed by Boca Pharmacal, Llc on October 19, 2011 and its listing in the NDC Directory is set to expire on December 02, 2013 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 64376-601-31?

The 11-digit format is 64376060131. 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	64376-601-31	5-4-2	64376-0601-31

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