Glycopyrrolate Injection
NDC Package 86211-113-10

11-digit billing NDC: 86211011310

Package Information

Glycopyrrolate injection is in AnesthesiaGlycopyrrolate injection 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 Jvet Pharmaceuticals Llc, this product is identified by NDC 86211-113 and is authorized under FDA application ANDA212612.

Identification & Billing

NDC Package Code
86211-113-10
Package Description
10 VIAL in 1 CARTON / 20 mL in 1 VIAL (86211-113-01)
Product Code
11-Digit Billing Format
86211011310
RxNorm Crosswalk
RxCUI: 238212 - glycopyrrolate 0.2 MG/ML Injectable Solution

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)
Usage Information
In AnesthesiaGlycopyrrolate injection 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 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 UlcerFor use in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.•Limitations of Use Glycopyrrolate injection is not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.

Regulatory & Marketing

Labeler Name
Jvet Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA212612
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-31-2025
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.

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Frequently Asked Questions

What is the distribution configuration for this product package?

The code 86211-113-10 identifies a specific commercial package of 10 vial in 1 carton / 20 ml in 1 vial (86211-113-01) of Glycopyrrolate, a human prescription drug labeled by Jvet Pharmaceuticals 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 Jvet Pharmaceuticals Llc on December 31, 2025. The current certification is valid through December 31, 2026.

How is this Jvet Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 86211011310. 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)
86211-113-10
11-Digit CMS (5-4-2)
86211-0113-10

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