GLYCOPYRROLATE 2 mg Tablet, 100-count
Other active recalls for Glycopyrrolate (different manufacturers) — 4 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Anticholinergic class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Glycopyrrolate is used in combination with other medications to treat ulcers in adults and children 12 years of age and older. Glycopyrrolate (Cuvposa) is used to reduce saliva and drooling in children between 3 and16 years of age that have certain medical conditions that cause drooling. Glycopyrrolate is in a class of medications called anticholinergics. It decreases stomach acid and saliva production by blocking the activity of a certain natural substance in the body.
Read the full MedlinePlus article ↗Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Glycopyrrolate — tap one for details:
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 3SY5LH9PMK
Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
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UNII L11K75P92J
A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
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UNII D9C330MD8B
Copovidone is a synthetic polymer made by combining two types of plastic-like molecules. It acts as a binder and film-former to help hold tablet ingredients together and improve how the medicine dissolves in your body.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.1993 | $19.93 / 100 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Glycopyrrolate 2 mg 13107-0015-01 | Aurolife | 100 tablets | $0.147 | AA | Availability likely | — |
| Glycopyrrolate 2 mg 23155-0607-01 | Heritage | 100 tablets | $0.147 | AA | Availability likely | — |
| Glycopyrrolate 2 mg 49884-0066-01 | Par | 100 tablets | $0.147 | AA | Availability likely | — |
| Glycopyrrolate 2 mg 62135-0735-60 | Chartwell | 60 tablets | $0.147 | AA | Availability likely | — |
| Glycopyrrolate 2 mg 69076-0476-01 | Quinn | 100 tablets | $0.147 | AA | Availability likely | — |
| Glycopyrrolate 2 mg 69315-0140-01 | Leading | 100 tablets | $0.147 | AA | Availability likely | — |
| Glycopyrrolate 2 mg 70752-0109-10 | QUAGEN | 100 tablets | $0.147 | AA | Availability likely | — |
| Glycopyrrolate 2 mgthis 15955-0318-01 | Alembic | 100 tablets | — | AA | FDA listed | — |
| Glycopyrrolate 2 mg 16571-0744-03 | Rising | 30 tablets | — | AA | FDA listed | — |
| Glycopyrrolate 1 mg 55111-0649-01 | Dr. | 100 tablets | — | AA | FDA listed | — |
| Glycopyrrolate 2 mg 60429-0666-01 | Golden | 100 tablets | — | AA | FDA listed | — |
| Glycopyrrolate 2 mg 63629-2207-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| Glycopyrrolate 2 mg 70518-3031-00 | REMEDYREPACK | 100 tablets | — | AA | FDA listed | — |
| Glycopyrrolate 2 mg 70518-4537-00 | REMEDYREPACK | 100 tablets | — | AA | FDA listed | — |
| Glycopyrrolate 2 mg 70518-4671-00 | REMEDYREPACK | 100 tablets | — | AA | FDA listed | — |
| Glycopyrrolate 2 mg 71335-1225-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Glycopyrrolate 2 mg 71335-2119-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Glycopyrrolate 2 mg 71335-2720-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Glycopyrrolate 2 mg 71921-0111-01 | Florida | 100 tablets | — | AA | FDA listed | — |
| Glycopyrrolate 2 mg 72162-1478-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| Glycopyrrolate 2 mg 72162-2598-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 15955-0318-01 You're viewing this | 100 TABLET in 1 BOTTLE, PLASTIC (15955-318-01) | 2012-10-19 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE For use as adjunctive therapy in the treatment of peptic ulcer.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION The dosage of Glycopyrrolate Tablets should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse reactions. The presently recommended maximum daily dosage of glycopyrrolate is 8 mg. Glycopyrrolate Tablets 1 mg.
The recommended initial dosage of glycopyrrolate for adults is one tablet three times daily (in the morning, early afternoon, and at bedtime). Some patients may require two tablets at bedtime to assure overnight control of symptoms. For maintenance, a dosage of one tablet twice a day is frequently adequate.
Glycopyrrolate Tablets 2 mg. The recommended dosage of glycopyrrolate for adults is one tablet two or three times daily at equally spaced intervals. Glycopyrrolate tablets are not recommended for use in pediatric patients under the age of 12 years.
DRUG INTERACTIONS There are no known drug interactions.
⛔ Contraindications ▾
CONTRAINDICATIONS Glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); paralytic ileus; intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis. Glycopyrrolate Tablets are contraindicated in those patients with a hypersensitivity to glycopyrrolate.
⚠️ Warnings ▾
WARNINGS In the presence of a high environmental temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with use of Glycopyrrolate Tablets. Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance treatment with this drug would be inappropriate and possibly harmful.
Glycopyrrolate Tablets may produce drowsiness or blurred vision. In this event, the patient should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery, or performing hazardous work while taking this drug. Theoretically, with overdosage, a curare-like action may occur, i.e., neuro-muscular blockade leading to muscular weakness and possible paralysis.
Pregnancy The safety of this drug during pregnancy has not been established. The use of any drug during pregnancy requires that the potential benefits of the drug be weighed against possible hazards to mother and child. Reproduction studies in rats revealed no teratogenic effects from glycopyrrolate; however, the potent anticholinergic action of this agent resulted in diminished rates of conception and of survival at weaning, in a dose-related manner.
Other studies in dogs suggest that this may be due to diminished seminal secretion which is evident at high doses of glycopyrrolate. Information on possible adverse effects in the pregnant female is limited to uncontrolled data derived from marketing experience. Such experience has revealed no reports of teratogenic or other fetus-damaging potential.
No controlled studies to establish the safety of the drug in pregnancy have been performed. Nursing Mothers It is not known whether this drug is excreted in human milk. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk.
Pediatric Use Since there is no adequate experience in pediatric patients who have received this drug, safety and efficacy in pediatric patients have not been established.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Anticholinergics produce certain effects, most of which are extensions of their fundamental pharmacological actions. Adverse reactions to anticholinergics in general may include xerostomia; decreased sweating; urinary hesitancy and retention; blurred vision; tachycardia; palpitations; dilatation of the pupil; cycloplegia; increased ocular tension; loss of taste; headaches; nervousness; mental confusion; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; constipation; bloated feeling; impotence; suppression of lactation; severe allergic reaction or drug idiosyncrasies including anaphylaxis, urticaria and other dermal manifestations.
Glycopyrrolate Tablets is chemically a quaternary ammonium compound; hence, its passage across lipid membranes, such as the blood-brain barrier, is limited in contrast to atropine sulfate and scopolamine hydrobromide. For this reason the occurrence of CNS related side effects is lower, in comparison to their incidence following administration of anticholinergics which are chemically tertiary amines that can cross this barrier readily.
🆘 Overdosage ▾
OVERDOSAGE The symptoms of overdosage of glycopyrrolate are peripheral in nature rather than central. 1. To guard against further absorption of the drug - use gastric lavage, cathartics, and/or enemas.
2. To combat peripheral anticholinergic effects (residual mydriasis, dry mouth, etc.) - utilize a quaternary ammonium anticholinesterase, such as neostigmine methylsulfate. 3.
To combat hypotension - use pressor amines (norepinephrine, metaraminol) i.v.; and supportive care. 4. To combat respiratory depression - administer oxygen; utilize a respiratory stimulant such as Dopram® i.v.; artificial respiration.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Glycopyrrolate, like other anticholinergic (antimuscarinic) agents, inhibits the action of acetylcholine on structures innervated by postganglionic cholinergic nerves and on smooth muscles that respond to acetylcholine but lack cholinergic innervation. These peripheral cholinergic receptors are present in the autonomic effector cells of smooth muscle, cardiac muscle, the sino-atrial node, the atrioventricular node, exocrine glands, and, to a limited degree, in the autonomic ganglia. Thus, it diminishes the volume and free acidity of gastric secretions and controls excessive pharyngeal, tracheal, and bronchial secretions.
Glycopyrrolate antagonizes muscarinic symptoms (e.g., bronchorrhea, bronchospasm, bradycardia, and intestinal hypermotility) induced by cholinergic drugs such as the anticholinesterases. The highly polar quaternary ammonium group of glycopyrrolate limits its passage across lipid membranes, such as the blood-brain barrier, in contrast to atropine sulfate and scopolamine hydrobromide, which are non-polar tertiary amines which penetrate lipid barriers easily.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Glycopyrrolate Tablets USP, 1 mg are white, round tablets with debossing of “OL” above bisect and “305” below bisect on one side and plain on the other side. They are supplied as follows: Bottles of 100 Tablets (NDC 15955-305-01) Glycopyrrolate Tablets USP, 2 mg are white, round tablets with debossing of “OL” above bisect and “318” below bisect on one side and plain on the other side. They are supplied as follows: Bottles of 100 Tablets (NDC 15955-318-01) Store at 20˚to 25˚C (68˚to 77˚F) [See USP Controlled Room Temperature].
Dispense in a tight container as defined in the USP. Keep this and all drugs out of the reach of children. Rx only Manufactured By: Appco Pharma LLC Piscataway, NJ 08854 Manufactured For: Alembic Labs LLC West Caldwell, NJ 07006 Rev.
12/2020
📋 Description ▾
DESCRIPTION Glycopyrrolate Tablets contain the synthetic anticholinergic, glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide. Glycopyrrolate Tablets 1 mg are white, round-shape, flat face bevel edge, scored, with “OL” above bisect and “305” below bisect.
Each tablet contains: Glycopyrrolate, USP..........................1 mg Glycopyrrolate Tablets 2 mg are white, round-shape, flat face bevel edge, scored, with “OL” above bisect and “318” below bisect. Each tablet contains: Glycopyrrolate, USP..........................2 mg Inactive Ingredients: Copovidone, Dibasic Calcium Phosphate, Lactose Anhydrous, Magnesium Stearate, Sodium Starch Glycolate.