Glycopyrrolate Injection
NDC Package 75834-196-10

11-digit billing NDC: 75834019610
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Glycopyrrolate injection is in Anesthesia Glycopyrrolate Injection, USP is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. This formulation utilizes a injection delivery system. Marketed by Nivagen Pharmaceuticals, Inc., this product is identified by NDC 75834-196 and is authorized under FDA application ANDA212591.

Identification & Billing

NDC Package Code
75834-196-10
Package Description
10 VIAL, MULTI-DOSE in 1 CARTON / 20 mL in 1 VIAL, MULTI-DOSE
Product Code
75834-196
11-Digit Billing Format
75834019610
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Glycopyrrolate
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
In Anesthesia Glycopyrrolate Injection, USP is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Glycopyrrolate Injection, USP may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants.In Peptic Ulcer For use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.

Regulatory & Marketing

Labeler Name
Nivagen Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA212591
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-25-2021
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 75834-196-10 identifies a specific commercial package of 10 vial, multi-dose in 1 carton / 20 ml in 1 vial, multi-dose of Glycopyrrolate, a human prescription drug labeled by Nivagen Pharmaceuticals, Inc.. 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 Nivagen Pharmaceuticals, Inc. on October 25, 2021. The current certification is valid through December 31, 2026.

How is this Nivagen Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 75834019610. 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)
75834-196-10
11-Digit CMS (5-4-2)
75834-0196-10

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