Glycopyrrolate
NDC Package 0641-6033-25

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 Hikma Pharmaceuticals Usa Inc., this product is identified by NDC 0641-6033 and is authorized under FDA application NDA017558.

Identification & Billing

NDC Package Code
0641-6033-25
Package Description
25 VIAL in 1 CARTON / 1 mL in 1 VIAL (0641-6033-01)
Product Code
0641-6033
11-Digit Billing Format
00641603325
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

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
Hikma Pharmaceuticals Usa Inc.
FDA Application #
NDA017558
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-06-1975
End Marketing Date
05-01-2015
Listing Expiration
05-01-2015
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 0641-6033-25 identifies a specific commercial package of 25 vial in 1 carton / 1 ml in 1 vial (0641-6033-01) of Glycopyrrolate, labeled by Hikma Pharmaceuticals Usa Inc.. 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 Hikma Pharmaceuticals Usa Inc. on February 06, 1975. The current certification is valid through May 01, 2015.

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 Hikma Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00641603325. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
0641-6033-25
11-Digit CMS (5-4-2)
00641-6033-25

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