Prescription medicine
Glycopyrrolate Brand names: Glyrx-Pf, Cuvposa, Glycate; first approved as Robinul Forte
Glycopyrrolate (Glycate) is a prescription medicine with an FDA approval on record since 1961. FDA's NDC Directory lists it from 58 generic labelers, and pharmacies paid $1.51 per mL (Glycopyrrolate 0.2 mg/mL vial) in the October 7, 2026 NADAC survey.
- Generic listed
- A presentation discontinued
Check it at the source: the glycopyrrolate FDA label on DailyMed (effective October 9, 2025, Hikma Pharmaceuticals USA Inc.); the NDA 12827 record on Drugs@FDA; every glycopyrrolate label on DailyMed.
Highlights of the record
FDA label of October 9, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageIn Anesthesia Glycopyrrolate Injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions;
Forms and strengths
- 1 mg
- 1.5 mg
- 2 mg
- 0.2 mg/ml
- 0.4 mg/2ml
- 1 mg/5ml
- 4 mg/20ml
Injection; tablet; injection (solution); solution; liquid.
On the market
- Earliest approval on file
- August 11, 1961 Robinul Forte, Casper Pharma Llc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 55 first August 25, 1981; 42 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 61 of which 58 under generic applications, 4 under brand applications, repackagers included
- Last listed patent
- December 7, 2036 Lonhala Magnair Kit solution; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $1.51 per mL Glycopyrrolate 0.2 mg/mL vial
- Shortage (FDA)
- None current 4 past records
- Recalls by its makers (FDA)
- 27 since 2013 1 Class I among all firms' recalls; latest July 16, 2026; 18 more by firms not listed as its makers
- FAERS reports
- 5,520 through July 30, 2026
What is glycopyrrolate used for?
From the label: indications and usageIn Anesthesia Glycopyrrolate 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. […]
FDA pharmacologic class: Anticholinergic and Cholinergic Muscarinic Antagonist.
Source: FDA drug label (Glycopyrrolate), Hikma Pharmaceuticals USA Inc., effective October 9, 2025 (SPL set 960d2dd0-008d-4ec1-ba2e-9388b28b23e2), via openFDA; the full label on DailyMed
Is there a generic for glycopyrrolate (Glycate)?
The FDA approved the first generic glycopyrrolate on August 25, 1981. 55 generic applications are approved; 42 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists glycopyrrolate from 58 labelers under a generic (ANDA) application and from 4 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Glyrx-Pf injection; a patent listed only for Lonhala Magnair Kit solution runs to December 7, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1961 earliest approval on file
- 1981 first generic approved
- 2036 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for glycopyrrolate (Glycate)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.51 per mL (Glycopyrrolate 0.2 mg/mL vial), about the same as a year earlier. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Glycopyrrolate 0.2 mg/mL vial (generic)
- Cuvposa 1 mg/5 mL solution (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Glycopyrrolate 0.2 mg/mL vial | Generic | $1.51 per mL | n/a | no change |
| Glycopyrrolate 1 mg tablet | Generic | $0.0997 per tablet | $2.99 | -6% |
| Glycopyrrolate 1 mg/5 mL oral solution | Generic | $0.202 per mL | n/a | -21% |
| Glycopyrrolate 2 mg tablet | Generic | $0.148 per tablet | $4.44 | -35% |
| Cuvposa 1 mg/5 mL solution | Brand | $1.01 per mL | n/a | -0.1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is glycopyrrolate in shortage?
No glycopyrrolate presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 4 records are all marked to be discontinued, the latest updated July 30, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Glycopyrrolate, Injection, .2 mg/1 mL (NDC 63323-578-01) | Fresenius Kabi USA, LLC | To Be Discontinued | July 30, 2026 |
| Glycopyrrolate, Injection, 0.2 mg per 1 mL (NDC 65219-801-01) | Fresenius Kabi USA, LLC | To Be Discontinued | July 30, 2026 |
| Glycopyrrolate, Injection, 0.4 mg per 2 mL (NDC 63323-578-02) | Fresenius Kabi USA, LLC | To Be Discontinued | July 30, 2026 |
| Glycopyrrolate, Injection, 1 mg per 5 mL (NDC 63323-578-05) | Fresenius Kabi USA, LLC | To Be Discontinued | July 30, 2026 |
Every glycopyrrolate presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has glycopyrrolate been recalled?
The FDA's Enforcement Report lists 45 recalls naming glycopyrrolate since 2013: 1 Class I (the most serious), 37 Class II, 7 Class III; 5 still ongoing. 18 of them are by firms that FDA's NDC Directory does not list as a maker of glycopyrrolate and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 16, 2026 | Class II | Fresenius Kabi USA, LLC | Presence of Particulate Matter: Hair was found in product |
| July 14, 2026 | Class II | Precision Dose Inc. | Failed Impurities/Degradation Specifications |
| December 15, 2025 | Class III | NOVADOZ PHARMACEUTICALS LLC | Failed Impurities/Degradation Specifications |
| March 31, 2025 | Class II | Denver Solutions, LLC DBA Leiters Health | Lack of Assurance of Sterility: Leaking/damaged syringes. |
| July 14, 2023 | Class II | Central Admixture Pharmacy Services, Inc. | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. |
| June 6, 2023 | Class III | HF Acquisition Co LLC | Labeling: Label Mix-up |
| May 18, 2023 | Class III | Aurolife Pharma, LLC | Failed Impurities/Degradation Specifications |
| February 7, 2023 | Class II | Accord Healthcare, Inc. | CGMP Deviations: recalling drug products following an FDA inspection. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the glycopyrrolate label say about other medicines?
The glycopyrrolate label names 6 other medicines in its interaction, contraindication or warning sections. The labels of 5 other medicines name glycopyrrolate. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amantadine | drug interactions | Effects of glycopyrrolate may be increased with concomitant administration of amantadine. |
| Atenolol | drug interactions | Consider decreasing the dose of glycopyrrolate during concomitant use. ( 7 ) Atenolol or metformin: |
| Digoxin | drug interactions | DRUG INTERACTIONS Digoxin tablets: Use with glycopyrrolate can increase digoxin serum levels. |
| Haloperidol | drug interactions | Consider dose reduction when used with glycopyrrolate. ( 7 ) Haloperidol or levodopa: Glycopyrrolate may decrease serum levels of haloperidol or levodopa. |
| Levodopa | drug interactions | Consider dose reduction when used with glycopyrrolate. ( 7 ) Haloperidol or levodopa: Glycopyrrolate may decrease serum levels of haloperidol or levodopa. |
| Metformin | drug interactions | Consider decreasing the dose of glycopyrrolate during concomitant use. ( 7 ) Atenolol or metformin: |
Other labels that name glycopyrrolate
Source: FDA drug label (Glycopyrrolate), Hikma Pharmaceuticals USA Inc., effective October 9, 2025 (SPL set 960d2dd0-008d-4ec1-ba2e-9388b28b23e2), via openFDA; the full label on DailyMed
What do FAERS reports show for glycopyrrolate?
The FDA Adverse Event Reporting System holds 5,520 reports that list glycopyrrolate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 660 are coded as a death and 2,343 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other anticholinergics
- the pharmacologic class, with prices and generics
- Glycopyrrolate side effects
- the label's list beside FAERS reports
- Glycopyrrolate shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other