Glycopyrrolate
NDC Package 71361-003-25

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

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

Glycopyrrolate is used with other drugs to treat a certain type of stomach/intestinal ulcer (peptic ulcer). Marketed by Piramal Critical Care Limited, this product is identified by NDC 71361-003 and is authorized under FDA application ANDA210842.

Identification & Billing

NDC Package Code
71361-003-25
Package Description
25 VIAL, GLASS in 1 CARTON / 5 mL in 1 VIAL, GLASS (71361-003-01)
Product Code
71361-003
11-Digit Billing Format
71361000325

Clinical Specifications

Proprietary Name
Glycopyrrolate
Dosage Form
-
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.

Regulatory & Marketing

Labeler Name
Piramal Critical Care Limited
FDA Application #
ANDA210842
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-24-2018
End Marketing Date
08-30-2019
Listing Expiration
08-30-2019
Exclude Flag
D
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 71361-003-25 identifies a specific commercial package of 25 vial, glass in 1 carton / 5 ml in 1 vial, glass (71361-003-01) of Glycopyrrolate, labeled by Piramal Critical Care Limited. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Piramal Critical Care Limited on July 24, 2018. The current certification is valid through August 30, 2019.

What are the primary indications for this medication?

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.

How is this Piramal Critical Care Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71361000325. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
71361-003-25
11-Digit CMS (5-4-2)
71361-0003-25

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.