Prescription medicine

Glycopyrrolate and neostigmine methylsulfate Brand names: Prevduo

Glycopyrrolate and neostigmine methylsulfate (Prevduo) is a prescription medicine with an FDA approval on record since 2023. No generic is listed in FDA's NDC Directory.

No generic listed

Check it at the source: the glycopyrrolate and neostigmine methylsulfate FDA label on DailyMed (effective April 10, 2024, Endo USA); the NDA 216903 record on Drugs@FDA; every glycopyrrolate and neostigmine methylsulfate label on DailyMed.

Highlights of the record

FDA label of April 10, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
PREVDUO ® , a fixed dose combination of cholinesterase inhibitor and antimuscarinic agent, is indicated in patients age two years and above for the reversal of the effects of nondepolarizing neuromuscular blocking agents (NMBA) after surgery, while decreasing the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) associated with cholinesterase inhibition following NMBA reversal administration.

Forms and strengths

1 mg/ml / 0.2 mg/ml

Injection.

On the market

Earliest approval on file: February 23, 2023 Prevduo, Azurity; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: No generic approved
Labelers listed (NDC): 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Last listed patent: October 25, 2038 Prevduo injection; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded

What is glycopyrrolate and neostigmine methylsulfate used for?

From the label: indications and usage
PREVDUO ® , a fixed dose combination of cholinesterase inhibitor and antimuscarinic agent, is indicated in patients age two years and above for the reversal of the effects of nondepolarizing neuromuscular blocking agents (NMBA) after surgery, while decreasing the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) associated with cholinesterase inhibition following NMBA reversal administration. […]

FDA pharmacologic class: Anticholinergic, Cholinergic Muscarinic Antagonist and Cholinesterase Inhibitor.

Source: FDA drug label (PREVDUO), NDA216903 (Azurity), as published by Endo USA, effective April 10, 2024 (SPL set dd8ad38f-247b-4948-a13c-8f3a4921b4f1), via openFDA; the full label on DailyMed

Is there a generic for glycopyrrolate and neostigmine methylsulfate (Prevduo)?

No generic glycopyrrolate and neostigmine methylsulfate is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 5 patents for Prevduo injection, the last expiring on October 25, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2023 earliest approval on file
2038 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What next?

Other anticholinergics: the pharmacologic class, with prices and generics
Check an interaction: what two or more labels say about each other