Glycopyrrolate Powder
NDC Package 59115-809-05

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Glycopyrrolate powders is glycopyrrolate solution is used to reduce excessive drooling caused by medical conditions (such as cerebral palsy). This formulation utilizes a powder delivery system. Marketed by Hikma Pharmaceuticals, this product is identified by NDC 59115-809.

Identification & Billing

NDC Package Code
59115-809-05
Package Description
1 kg in 1 CANISTER
Product Code
59115-809
11-Digit Billing Format
59115080905

Clinical Specifications

Proprietary Name
Glycopyrrolate
Non-Proprietary Name
Glycopyrrolate
Substance Name
Glycopyrrolate
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
GLYCOPYRROLATE 1 kg/kg
Usage Information
Glycopyrrolate solution is used to reduce excessive drooling caused by medical conditions (such as cerebral palsy). This medication works by decreasing the amount of saliva you make. Glycopyrrolate belongs to a class of drugs known as anticholinergics.

Regulatory & Marketing

Labeler Name
Hikma Pharmaceuticals
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
09-21-2011
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 59115-809-05 identifies a specific commercial package of 1 kg in 1 canister of Glycopyrrolate (UNFINISHED drug), a bulk ingredient labeled by Hikma Pharmaceuticals. This powder is formulated for use and contains glycopyrrolate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Hikma Pharmaceuticals on September 21, 2011. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Glycopyrrolate solution is used to reduce excessive drooling caused by medical conditions (such as cerebral palsy). This medication works by decreasing the amount of saliva you make. Glycopyrrolate belongs to a class of drugs known as anticholinergics.

How is this Hikma Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59115080905. 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)
59115-809-05
11-Digit CMS (5-4-2)
59115-0809-05

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