Glycopyrrolate Oral Solution Liquid
NDC Package 51672-5316-9

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

Package Information

Glycopyrrolate Oral Solution liquids is glycopyrrolate solution is used to reduce excessive drooling caused by medical conditions (such as cerebral palsy). This formulation utilizes a liquid delivery system. Marketed by Sun Pharmaceutical Industries, Inc., this product is identified by NDC 51672-5316 and is authorized under FDA application ANDA212467.

Identification & Billing

NDC Package Code
51672-5316-9
Package Description
1 BOTTLE in 1 CARTON / 500 mL in 1 BOTTLE
Product Code
51672-5316
11-Digit Billing Format
51672531609
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Glycopyrrolate Oral Solution
Non-Proprietary Name
Glycopyrrolate Oral Solution
Substance Name
Glycopyrrolate
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
GLYCOPYRROLATE 1 mg/5mL
Pharmacologic Class
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
Sun Pharmaceutical Industries, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA212467
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-05-2022
Listing Expiration
12-31-2027
Exclude Flag
N
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 51672-5316-9 identifies a specific commercial package of 1 bottle in 1 carton / 500 ml in 1 bottle of Glycopyrrolate Oral Solution, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. This liquid is formulated for oral 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 Sun Pharmaceutical Industries, Inc. on July 05, 2022. The current certification is valid through December 31, 2027.

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 Sun Pharmaceutical Industries, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51672531609. 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 (5-4-1)
51672-5316-9
11-Digit CMS (5-4-2)
51672-5316-09

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