Glycopyrrolate
NDC Package 0904-6521-61

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 Major Pharmaceuticals, this product is identified by NDC 0904-6521 and is authorized under FDA application ANDA090195.

Identification & Billing

NDC Package Code
0904-6521-61
Package Description
100 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK
Product Code
0904-6521
11-Digit Billing Format
00904652161
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA

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
Major Pharmaceuticals
FDA Application #
ANDA090195
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-18-2016
End Marketing Date
03-31-2019
Listing Expiration
03-31-2019
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 0904-6521-61 identifies a specific commercial package of 100 blister pack in 1 carton / 1 tablet in 1 blister pack of Glycopyrrolate, labeled by Major Pharmaceuticals. 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 Major Pharmaceuticals on March 18, 2016. The current certification is valid through March 31, 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 Major Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00904652161. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. 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 (4-4-2)
0904-6521-61
11-Digit CMS (5-4-2)
00904-6521-61

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