Glycopyrrolate 1ml Injection
NDC Package 70700-264-22

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

Package Information

Glycopyrrolate 1ml (glycopyrrolate) injection is glycopyrrolate solution is used to reduce excessive drooling caused by medical conditions (such as cerebral palsy). This formulation utilizes a injection delivery system. Marketed by Xiromed Llc, this product is identified by NDC 70700-264 and is authorized under FDA application ANDA212227.

Identification & Billing

NDC Package Code
70700-264-22
Package Description
1 VIAL in 1 CARTON / 1 mL in 1 VIAL
Product Code
70700-264
11-Digit Billing Format
70700026422
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Glycopyrrolate 1ml
Non-Proprietary Name
Glycopyrrolate
Substance Name
Glycopyrrolate
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
GLYCOPYRROLATE .2 mg/mL
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
Xiromed Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA212227
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-03-2018
Listing Expiration
12-31-2026
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 70700-264-22 identifies a specific commercial package of 1 vial in 1 carton / 1 ml in 1 vial of Glycopyrrolate 1ml, a human prescription drug labeled by Xiromed Llc. This injection is formulated for intramuscular; intravenous 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 Xiromed Llc on August 03, 2018. 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 Xiromed Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70700026422. 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)
70700-264-22
11-Digit CMS (5-4-2)
70700-0264-22

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