Glycopyrrolate Solution
NDC Package 69452-406-88

11-digit billing NDC: 69452040688 · Billing unit: ML · 473 ML per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Glycopyrrolate solution is glycopyrrolate oral solution is indicated to reduce chronic severe drooling in patients aged 3 years to 16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy). This formulation utilizes a solution delivery system. Marketed by Bionpharma Inc., this product is identified by NDC 69452-406 and is authorized under FDA application ANDA220062.

Identification & Billing

NDC Package Code
69452-406-88
Package Description
1 BOTTLE in 1 CARTON / 473 mL in 1 BOTTLE
Product Code
69452-406
11-Digit Billing Format
69452040688
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
473 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Glycopyrrolate
Non-Proprietary Name
Glycopyrrolate
Substance Name
Glycopyrrolate
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
GLYCOPYRROLATE 1 mg/5mL
Pharmacologic Class
Usage Information
Glycopyrrolate oral solution is indicated to reduce chronic severe drooling in patients aged 3 years to 16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy).

Regulatory & Marketing

Labeler Name
Bionpharma Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA220062
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-11-2026
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 69452-406-88 identifies a specific commercial package of 1 bottle in 1 carton / 473 ml in 1 bottle of Glycopyrrolate, a human prescription drug labeled by Bionpharma Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 473 billable units per package. This solution 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 Bionpharma Inc. on May 11, 2026. The current certification is valid through December 31, 2027.

How is this Bionpharma Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69452040688. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 473 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 (5-3-2)
69452-406-88
11-Digit CMS (5-4-2)
69452-0406-88

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