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Glycopyrrolate Oral Solution 1 mg/5mL Solution — NDC 82983-428-47 (Billing 82983-0428-47)

by AJENAT PHARMACEUTICALS LLC · 1 BOTTLE in 1 BOTTLE / 473 mL in 1 BOTTLE

This is a package of Glycopyrrolate Oral Solution 1 mg/5mL Solution from AJENAT PHARMACEUTICALS LLC, marketed since Dec 2025 and currently FDA-listed. It is this product's only package size.

NDC 82983-0428-47
🏷️ FDA NDC (as labeled) 82983-428-47 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 82983-428-47 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
82983 labeler · 428 product · 47 package
Package marketed since
Dec 12, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0382983428478
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Glycopyrrolate (different manufacturers) — 4 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jul 16, 2026 — Presence of Particulate Matter: Hair was found in product (Fresenius Kabi USA, LLC) · FDA recall D-0725-2026
Class II · Jul 14, 2026 — Failed Impurities/Degradation Specifications (Precision Dose Inc.) · FDA recall D-0741-2026
Class III · Dec 15, 2025 — Failed Impurities/Degradation Specifications (NOVADOZ PHARMACEUTICALS LLC) · FDA recall D-0300-2026
Class II · Dec 16, 2022 — Failed Impurities/Degradation Specifications (Aurolife Pharma, LLC) · FDA recall D-0087-2023
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 82983-428-47
Product NDC 82983-428
11-digit billing NDC 82983042847
RxCUI 999961
UNII V92SO9WP2I
UPC 0382983428478
Application # ANDA219267
SPL Set ID 7049feaf-004a-481f-b129-996b21c3170a
Established class (EPC) Anticholinergic; Cholinergic Muscarinic Antagonist
Mechanism of action Cholinergic Antagonists; Cholinergic Muscarinic Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-12-12
Route ORAL
Dosage form SOLUTION
Substance GLYCOPYRROLATE
TE code (Orange Book) AA · RLD · RS
Quick answers
  • RxCUI (RxNorm): 999961
Why two NDCs? The FDA registers this code as 82983-428-47 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 82983-0428-47. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Anticholinergic class.

Pharmacologic class Anticholinergic, Cholinergic Muscarinic Antagonist
Drug family (ATC) Antihidrotics
How it works Cholinergic Muscarinic Antagonists, Cholinergic Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer mLPer 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 $0.5483 $259.35 / 473 ml
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
82983-0428-47 You're viewing this Main listing 1 BOTTLE in 1 BOTTLE / 473 mL in 1 BOTTLE 2025-12-12 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Glycopyrrolate 1 mg/5mL 31722-0016-47 Camber 1 bottle $0.202 AA Availability likely —
Glycopyrrolate 1 mg/5mL 49884-0042-33 Par 16 ml $0.202 AA Availability likely —
Glycopyrrolate Oral Solution 1 mg/5mL 51672-5316-09 Sun 1 bottle $0.202 AA Availability likely —
Glycopyrrolate 1 mg/5mL 59651-0435-47 Aurobindo 1 bottle $0.202 AA Availability likely —
glycopyrrolate 1 mg/5mL 71656-0061-16 Saptalis 1 bottle $0.202 AA Availability likely —
Glycopyrrolate 1 mg/5mL 72205-0070-72 Novadoz 1 bottle $0.202 AA Availability likely —
Glycopyrrolate 1 mg/5mL 72603-0240-01 NorthStar 1 bottle $0.202 AA Availability likely —
Cuvposa 1 mg/5mL 00259-0501-16 Merz 1 bottle $1.007 AA Availability likely —
Glycopyrrolate 1 mg/5mL 17856-1016-01 Atlantic 120 syringes — AA FDA listed —
Glycopyrrolate 1 mg/5mL 62135-0961-47 Chartwell 473 ml — AA FDA listed —
Glycopyrrolate 1 mg/5mL 63629-9592-01 Bryant 473 ml — AA FDA listed —
Glycopyrrolate 1 mg/5mL 68094-0073-58 Precision 1 syringe — AA FDA listed —
glycopyrrolate 1 mg/5mL 69452-0406-88 Bionpharma 1 bottle — AA FDA listed —
Glycopyrrolate Oral Solution 1 mg/5mL 70010-0106-44 Granules 473 ml — AA FDA listed —
Glycopyrrolate Oral Solution 1 mg/5mLthis 82983-0428-47 AJENAT 1 bottle — AA FDA listed —
Glycopyrrolate 1 mg/5mL 70752-0175-12 QUAGEN 1 bottle — AA FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2025
On the market since
Dec 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

FlavorCherry
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerAJENAT PHARMACEUTICALS LLC
Application holderAJENAT PHARMACEUTICALS LLC
FDA applicationANDA219267 (ANDA)
Labeler code82983
First marketedDec 2025
Product typeHuman Prescription Drug
Portfolio15 products on file

More NDCs from AJENAT PHARMACEUTICALS LLC labeler code 82983

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 61 words ▾

1 INDICATIONS AND USAGE Glycopyrrolate Oral Solution is indicated to reduce chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy). Glycopyrrolate Oral Solution is an anticholinergic indicated to reduce chronic severe drooling in patients aged 3-16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy). ( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Glycopyrrolate Oral Solution must be measured and administered with an accurate measuring device [see Patient Counseling Information (17) ]. Initiate dosing at 0.02 mg/kg orally three times daily and titrate in increments of 0.02 mg/kg every 5-7 days based on therapeutic response and adverse reactions. The maximum recommended dosage is 0.1 mg/kg three times daily not to exceed 1.5-3 mg per dose based upon weight.

For greater detail, see Table 1 . During the four-week titration period, dosing can be increased with the recommended dose titration schedule while ensuring that the anticholinergic adverse events are tolerable. Prior to each increase in dose, review the tolerability of the current dose level with the patient's caregiver.

Glycopyrrolate Oral Solution should be dosed at least one hour before or two hours after meals. The presence of high fat food reduces the oral bioavailability of Glycopyrrolate Oral Solution if taken shortly after a meal [see Clinical Pharmacology (12.3) ]. Table 1: Recommended Dose Titration Schedule (each dose to be given three times daily) Weight Dose Level 1 Dose Level 2 Dose Level 3 Dose Level 4 Dose Level 5 kg lbs (~0.02 mg/kg) (~0.04 mg/kg) (~0.06 mg/kg) (~0.08 mg/kg) (~0.1 mg/kg) 13-17 27-38 0.3 mg 1.5 mL 0.6 mg 3 mL 0.9 mg 4.5 mL 1.2 mg 6 mL 1.5 mg 7.5 mL 18-22 39-49 0.4 mg 2 mL 0.8 mL 4 mL 1.2 mg 6 mL 1.6 mg 8 mL 2.0 mg 10 mL 23-27 50-60 0.5 mg 2.5 mL 1.0 mg 5 mL 1.5 mg 7.5 mL 2.0 mg 10 mL 2.5 mg 12.5 mL 28-32 61-71 0.6 mg 3 mL 1.2 mg 6 mL 1.8 mg 9 mL 2.4 mg 12 mL 3.0 mg 15 mL 33-37 72-82 0.7 mg 3.5 mL 1.4 mg 7 mL 2.1 mg 10.5 mL 2.8 mg 14 mL 3.0 mg 15 mL 38-42 83-93 0.8 mg 4 mL 1.6 mg 8 mL 2.4 mg 12 mL 3.0 mg 15 mL 3.0 mg 15 mL 43-47 94-104 0.9 mg 4.5 mL 1.8 mg 9 mL 2.7 mg 13.5 mL 3.0 mg 15 mL 3.0 mg 15 mL ≥48 ≥105 1.0 mg 5 mL 2.0 mg 10 mL 3.0 mg 15 mL 3.0 mg 15 mL 3.0 mg 15 mL • Initiate dosing at 0.02 mg/kg three times daily and titrate in increments of 0.02 mg/kg every 5-7 days, based on therapeutic response and adverse reactions.

( 2 ) • Maximum recommended dose is 0.1 mg/kg three times daily, not to exceed 1.5-3 mg per dose based upon weight. ( 2 ) • Administer at least one hour before or two hours after meals. ( 2 )

💊 Dosage Forms and Strengths 36 words ▾

3 DOSAGE FORMS AND STRENGTHS Glycopyrrolate Oral Solution is available as a 1mg/5 mL clear, cherry-flavored solution for oral administration in 16 ounce bottles. 1 mg/5 mL, oral solution in 16 ounce bottles. ( 3 )

⛔ Contraindications 93 words ▾

4 CONTRAINDICATIONS Glycopyrrolate Oral Solution is contraindicated in: • Patients with medical conditions that preclude anticholinergic therapy (e.g., glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis). • Patients taking solid oral dosage forms of potassium chloride. The passage of potassium chloride tablets through the gastrointestinal (GI) tract may be arrested or delayed with coadministration of Glycopyrrolate Oral Solution. • Medical conditions that preclude anticholinergic therapy.

( 4 ) • Concomitant use of solid oral dosage forms of potassium chloride. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS • Constipation or intestinal pseudo-obstruction: May present as abdominal distention, pain, nausea, or vomiting. Assess patients for constipation, particularly within 4-5 days of initial dosing or after a dose increase. ( 5.1 ) • Incomplete mechanical intestinal obstruction: May present as diarrhea.

If obstruction is suspected, discontinue Glycopyrrolate Oral Solution and evaluate. ( 5.2 ) • High ambient temperature: To reduce the risk of heat prostration, avoid high temperatures. ( 5.3 )

5.1Constipation or Intestinal Pseudo-obstruction Constipation is a common dose-limiting adverse reaction which sometimes leads to glycopyrrolate discontinuation [see Adverse Reactions (6.1) ]. Assess patients for constipation, particularly within 4-5 days of initial dosing or after a dose increase. Intestinal pseudo-obstruction has been reported and may present as abdominal distention, pain, nausea or vomiting.

5.2Incomplete Mechanical Intestinal Obstruction Diarrhea may be an early symptom of incomplete mechanical intestinal obstruction, especially in patients with ileostomy or colostomy. If incomplete mechanical intestinal obstruction is suspected, discontinue treatment with Glycopyrrolate Oral Solution and evaluate for intestinal obstruction.

5.3High Ambient Temperatures In the presence of high ambient temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with the use of anticholinergic drugs such as Glycopyrrolate Oral Solution. Advise patients/caregivers to avoid exposure of the patient to hot or very warm environmental temperatures.

5.4Operating Machinery or an Automobile Glycopyrrolate Oral Solution may produce drowsiness or blurred vision. As appropriate for a given age, warn the patient not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery, or performing hazardous work while taking Glycopyrrolate Oral Solution.

5.5Anticholinergic Drug Effects Use Glycopyrrolate Oral Solutionwith caution in patients with conditions that are exacerbated by anticholinergic drug effects including: • Autonomic neuropathy • Renal disease • Ulcerative colitis – Large doses may suppress intestinal motility to the point of producing a paralytic ileus and for this reason may precipitate or aggravate "toxic megacolon", a serious complication of the disease • Hyperthyroidism • Coronary heart disease, congestive heart failure, cardiac tachyarrhythmias, tachycardia, and hypertension • Hiatal hernia associated with reflux esophagitis, since anticholinergic drugs may aggravate this condition

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: • Constipation or intestinal pseudo-obstruction [see Warnings and Precautions (5.1) ] • Incomplete mechanical intestinal obstruction [see Warnings and Precautions (5.2) ] The most common adverse reactions reported with Glycopyrrolate Oral Solution are dry mouth, vomiting, constipation, flushing, and nasal congestion. The most common adverse reactions (incidence ≥30%) are dry mouth, vomiting, constipation, flushing, and nasal congestion.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Ajenat Pharmaceuticals LLC at 1-727-234-8872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.The data described below reflect exposure to Glycopyrrolate Oral Solution in 151 subjects, including 20 subjects who participated in an 8-week placebo-controlled study (Study 1) and 137 subjects who participated in a 24-week open-label study (six subjects who received Glycopyrrolate Oral Solution in the placebo-controlled study and 131 new subjects).Table 2 presents adverse reactions reported by ≥ 15% of Glycopyrrolate Oral Solution-treated subjects from the placebo-controlled clinical trial.

Table 2: Adverse Reactions Occurring in ≥ 15% of Glycopyrrolate Oral Solution-Treated Subjects and at a Greater Frequency than Placebo in Study 1 Glycopyrrolate Oral Solution (N=20) n (%) Placebo (N=18) n (%) Dry Mouth 8 (40%) 2 (11%) Vomiting 8 (40%) 2 (11%) Constipation 7 (35%) 4 (22%) Flushing 6 (30%) 3 (17%) Nasal Congestion 6 (30%) 2 (11%) Headache 3 (15%) 1 (6%) Sinusitis 3 (15%) 1 (6%) Upper Respiratory Tract Infection 3 (15%) 0 Urinary Retention 3 (15%) 0 The following adverse reactions occurred at a rate of <2% of patients receiving Glycopyrrolate Oral Solution in the open-label study.

Gastrointestinal: Abdominal distention, abdominal pain, stomach discomfort, chapped lips, flatulence, retching, dry tongue General Disorders: Irritability, pain Infections: Pneumonia, sinusitis, tracheostomy infection, upper respiratory tract infection, urinary tract infection Investigations: Heart rate increase Metabolism and Nutrition: Dehydration Nervous System: Headache, convulsion, dysgeusia, nystagmus Psychiatric: Agitation, restlessness, abnormal behavior, aggression, crying, impulse control disorder, moaning, mood altered Respiratory: Increased viscosity of bronchial secretion, nasal congestion, nasal dryness Skin: Dry skin, pruritus, rash Vascular: Pallor

6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of other formulations of glycopyrrolate for other indications. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Additional adverse reactions identified during postapproval use of glycopyrrolate tablets include: loss of taste and suppression of lactation.

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS • Digoxin tablets: Use with glycopyrrolate can increase digoxin serum levels. Monitor patients and consider use of alternative dosage forms of digoxin. ( 7 ) • Amantadine: Effects of glycopyrrolate may be increased with concomitant administration of amantadine.

Consider decreasing the dose of glycopyrrolate during concomitant use. ( 7 ) • Atenolol or metformin: Glycopyrrolate may increase serum levels of atenolol or metformin. Consider dose reduction when used with glycopyrrolate.

( 7 ) • Haloperidol or levodopa: Glycopyrrolate may decrease serum levels of haloperidol or levodopa. Consider a dose increase when used with glycopyrrolate. ( 7 ) Drugs Affected by Reduced GI Transit Time Glycopyrrolate reduces GI transit time, which may result in altered release of certain drugs when formulated in delayed- or controlled-release dosage forms. • The passage of potassium chloride tablets through the GI tract may be arrested or delayed with coadministration of glycopyrrolate.

Solid dosage forms of potassium chloride are contraindicated [see Contraindications (4) ]. • Digoxin administered as slow dissolution oral tablets may have increased serum levels and enhanced action when administered with glycopyrrolate. Monitor patients receiving slow dissolution digoxin for increased action if glycopyrrolate is coadministered regularly. Consider the use of other oral dosage forms of digoxin (e.g., elixir or capsules).

Amantadine The anticholinergic effects of glycopyrrolate may be increased with concomitant administration of amantadine. Consider decreasing the dose of glycopyrrolate during coadministration of amantadine. Drugs Whose Plasma Levels May be Increased by Glycopyrrolate Coadministration of glycopyrrolate may result in increased levels of certain drugs. • Atenolol's bioavailability may be increased with coadministration of glycopyrrolate.

A reduction in the atenolol dose may be needed. • Metformin plasma levels may be elevated with coadministration of glycopyrrolate, increasing metformin's pharmacologic and toxic effects. Monitor clinical response to metformin with concomitant glycopyrrolate administration; consider a dose reduction of metformin if warranted. Drugs Whose Plasma Levels May be Decreased by Glycopyrrolate Coadministration of glycopyrrolate may result in decreased levels of certain drugs. • Haloperidol's serum level may be decreased when coadministered with glycopyrrolate, resulting in worsening of schizophrenic symptoms, and development of tardive dyskinesia.

Closely monitor patients if coadministration cannot be avoided. • Levodopa's therapeutic effect may be reduced with glycopyrrolate administration. Consider increasing the dose of levodopa.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Pediatric use: The safety and effectiveness of glycopyrrolate has not been established in patients less than 3 years of age. ( 8.4 ) • Renal impairment: Use Glycopyrrolate Oral Solution with caution in patients with renal impairment. ( 8.6 )

8.1Pregnancy Risk Summary There are no available data in pregnant women for Glycopyrrolate Oral Solution to inform decisions concerning any drug-associated risks. In pregnant rats, daily oral administration of glycopyrrolate during organogenesis at dose exposures 2.5 to 113 times the exposure at the maximum recommended human dose (MRHD) did not result in an increased incidence of gross external or visceral defects [see Data ] . When glycopyrrolate was administered intravenously to pregnant rabbits during organogenesis at dose exposures equivalent to up to approximately 7.8 times the exposure at the MRHD, no adverse effects on embryo-fetal development were seen.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Animal Data Glycopyrrolate was orally administered to pregnant rats at dosages of 50, 200, and 400 mg/kg/day during the period of organogenesis.

These dosages resulted in systemic exposures (estimated AUC 0-inf values) approximately 2.5, 23, and 113 times, respectively, the estimated systemic exposure in humans at the MRHD (9 mg per day, administered in three divided doses). Glycopyrrolate had no effect on maternal survival, but significantly reduced mean maternal body weight gain over the period of dosing at all dosages evaluated. Mean fetal weight was significantly reduced in the 200 and 400 mg/kg/day dose groups.

There were two litters with all resorbed fetuses in the 400 mg/kg/day dose group. There were no effects of treatment on the incidence of gross external or visceral defects. Minor treatment-related skeletal effects included reduced ossification of various bones in the 200 and 400 mg/kg/day dose groups; these skeletal effects were likely secondary to maternal toxicity.

Glycopyrrolate was intravenously administered to pregnant rabbits at dosages of 0.1, 0.5, and 1.0 mg/kg/day during the period of organogenesis. These dosages resulted in systemic exposures (estimated AUC 0-inf values) approximately 0.8, 4.6, and 7.8 times, respectively, the estimated systemic exposure in humans at the MRHD. Glycopyrrolate did not affect maternal survival under the conditions of this study.

Mean maternal body weight gain and mean food consumption over the period of dosing were lower than the corresponding control value in the 0.5 and 1.0 mg/kg/day treatment groups. There were no effects of treatment on fetal parameters, including fetal survival, mean fetal weight, and the incidence of external, visceral, or skeletal defects. Female rats that were pregnant or nursing were orally dosed with glycopyrrolate daily at dosages of 0, 50, 200, or 400 mg/kg/day, beginning on day 7 of gestation, and continuing until day 20 of lactation.

These dosages resulted in systemic exposures (estimated AUC 0-inf values) approximately 2.5, 23, and 113 times, respectively, the estimated systemic exposure in humans at the MRHD (9 mg per day, administered in three divided doses). Mean body weight of pups in all treatment groups was reduced compared to the control group during the period of nursing, but eventually recovered to be comparable to the control group, post-weaning. No other notable delivery or litter parameters were affected by treatment in any group, including no effects on mean duration of gestation or mean numbers of live pups per litter.

No treatment-related effects on survival or adverse clinical signs were observed in pups. There were no effects of maternal treatment on behavior, learning, memory, or reproductive function of pups.

8.2Lactatio… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary There are no available data in pregnant women for Glycopyrrolate Oral Solution to inform decisions concerning any drug-associated risks. In pregnant rats, daily oral administration of glycopyrrolate during organogenesis at dose exposures 2.5 to 113 times the exposure at the maximum recommended human dose (MRHD) did not result in an increased incidence of gross external or visceral defects [see Data ] . When glycopyrrolate was administered intravenously to pregnant rabbits during organogenesis at dose exposures equivalent to up to approximately 7.8 times the exposure at the MRHD, no adverse effects on embryo-fetal development were seen.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Animal Data Glycopyrrolate was orally administered to pregnant rats at dosages of 50, 200, and 400 mg/kg/day during the period of organogenesis.

These dosages resulted in systemic exposures (estimated AUC 0-inf values) approximately 2.5, 23, and 113 times, respectively, the estimated systemic exposure in humans at the MRHD (9 mg per day, administered in three divided doses). Glycopyrrolate had no effect on maternal survival, but significantly reduced mean maternal body weight gain over the period of dosing at all dosages evaluated. Mean fetal weight was significantly reduced in the 200 and 400 mg/kg/day dose groups.

There were two litters with all resorbed fetuses in the 400 mg/kg/day dose group. There were no effects of treatment on the incidence of gross external or visceral defects. Minor treatment-related skeletal effects included reduced ossification of various bones in the 200 and 400 mg/kg/day dose groups; these skeletal effects were likely secondary to maternal toxicity.

Glycopyrrolate was intravenously administered to pregnant rabbits at dosages of 0.1, 0.5, and 1.0 mg/kg/day during the period of organogenesis. These dosages resulted in systemic exposures (estimated AUC 0-inf values) approximately 0.8, 4.6, and 7.8 times, respectively, the estimated systemic exposure in humans at the MRHD. Glycopyrrolate did not affect maternal survival under the conditions of this study.

Mean maternal body weight gain and mean food consumption over the period of dosing were lower than the corresponding control value in the 0.5 and 1.0 mg/kg/day treatment groups. There were no effects of treatment on fetal parameters, including fetal survival, mean fetal weight, and the incidence of external, visceral, or skeletal defects. Female rats that were pregnant or nursing were orally dosed with glycopyrrolate daily at dosages of 0, 50, 200, or 400 mg/kg/day, beginning on day 7 of gestation, and continuing until day 20 of lactation.

These dosages resulted in systemic exposures (estimated AUC 0-inf values) approximately 2.5, 23, and 113 times, respectively, the estimated systemic exposure in humans at the MRHD (9 mg per day, administered in three divided doses). Mean body weight of pups in all treatment groups was reduced compared to the control group during the period of nursing, but eventually recovered to be comparable to the control group, post-weaning. No other notable delivery or litter parameters were affected by treatment in any group, including no effects on mean duration of gestation or mean numbers of live pups per litter.

No treatment-related effects on survival or adverse clinical signs were observed in pups. There were no effects of maternal treatment on behavior, learning, memory, or reproductive function of pups.

🧒 Pediatric Use 39 words ▾

8.4Pediatric Use Glycopyrrolate Oral Solution was evaluated for chronic severe drooling in patients aged 3-16 years with neurologic conditions associated with problem drooling. Glycopyrrolate Oral Solution has not been studied in subjects under the age of 3 years.

🧓 Geriatric Use 17 words ▾

8.5Geriatric Use Clinical studies of Glycopyrrolate Oral Solution did not include subjects aged 65 and over.

🆘 Overdosage 110 words ▾

10 OVERDOSAGE Because glycopyrrolate is a quaternary amine which does not easily cross the blood-brain barrier, symptoms of glycopyrrolate overdosage are generally more peripheral in nature rather than central compared to other anticholinergic agents. In case of accidental overdose, therapy may include: • Maintain an open airway, providing ventilation as necessary. • Managing any acute conditions such as hyperthermia, coma and or seizures as applicable, and managing any jerky myoclonic movements or choreoathetosis which may lead to rhabdomyolysis in some cases of anticholinergic overdosage. • Administering a quaternary ammonium anticholinesterase such as neostigmine to help alleviate-peripheral anticholinergic effects such as anticholinergic induced ileus. • Administering activated charcoal orally as appropriate.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Glycopyrrolate is a competitive inhibitor of acetylcholine receptors that are located on certain peripheral tissues, including salivary glands. Glycopyrrolate indirectly reduces the rate of salivation by preventing the stimulation of these receptors.

12.2Pharmacodynamics Glycopyrrolate inhibits the action of acetylcholine on salivary glands thereby reducing the extent of salivation.

12.3Pharmacokinetics Absorption In a parallel study of children (n=6 per group) aged 7-14 years undergoing intraocular surgery, subjects received either intravenous (IV) or oral glycopyrrolate as a premedication. The mean absolute bioavailability of oral glycopyrrolate tablets was low (approximately 3%) and highly variable among subjects (range 1.3 to 13.3%). A similar pattern of low and variable relative bioavailability is seen in adults.

Analysis of population pharmacokinetic data from normal adults and children with cerebral palsy associated chronic moderate to severe drooling failed to demonstrate linear pharmacokinetics across the dose range. In the same analysis, population estimates of the apparent oral clearance (scaled by weight in children and adults) ranged from 5.28 -

38.95L/hr/kg for healthy adults and 8.07 -

25.65L/hr/kg for patients with cerebral palsy, a reflection of the low and highly variable oral bioavailability of glycopyrrolate. Absorption of Glycopyrrolate Oral Solution (fasting) was compared to that of a marketed glycopyrrolate oral tablet. The C max after oral solution administration was 23% lower compared to tablet administration and AUC 0-inf was 28% lower after oral solution administration.

Mean C max after oral solution administration in the fasting state was 0.318 ng/mL, and mean AUC 0-24 was 1.74 ng∙hr/mL. Mean time to maximum plasma concentration for Glycopyrrolate Oral Solution was 3.1 hours, and mean plasma half-life was 3.0 hours. In healthy adults, a high fat meal was shown to significantly affect the absorption of glycopyrrolate oral solution (10 mL, 1 mg/5 mL).

The mean C max under fed high fat meal conditions was approximately 74% lower than the C max observed under fasting conditions. Similarly, mean AUC 0-T was reduced by about 78% by the high fat meal compared with the fasting AUC 0-T . A high fat meal markedly reduces the oral bioavailability of Glycopyrrolate Oral Solution.

Therefore, Glycopyrrolate Oral Solution should be dosed at least one hour before or two hours after meals. Pharmacokinetic results (mean ± SD) are described in Table 3. Table 3: Pharmacokinetic Parameters (mean±SD) for Glycopyrrolate Oral Solution, Fasting and Fed, in Healthy Adults C max (ng/mL) T max (hrs) AUC 0-T (ng∙hr/mL) AUC 0-Inf (ng∙hr/mL) T 1/2 (hrs) Fasting (n=37) 0.318 ± 0.190 3.10 ± 1.08 1.74 ± 1.07 1.81 ± 1.09 3.0 ±

1.2Fed (n=36) 0.084 ± 0.081 2.60 ± 1.12 0.38 ± 0.14 0.46 ± 0.13 n=35 3.2 ±

1.1Distribution After IV administration, glycopyrrolate has a mean volume of distribution in children aged 1 to 14 years of approximately 1.3 to

1.8L/kg, with a range from 0.7 to

3.9L/kg. In adults aged 60-75 years, the volume of distribution was lower (0.42 L/kg +/- 0.22). Metabolism In adult patients who underwent surgery for cholelithiasis and were given a single IV dose of tritiated glycopyrrolate, approximately 85% of total radioactivity was excreted in urine and <5% was present in T-tube drainage of bile.

In both urine and bile, >80% of the radioactivity corresponded to unchanged drug. These data suggest a small proportion of IV glycopyrrolate is excreted as one or more metabolites. Elimination Approximately 65-80% of an IV glycopyrrolate dose was eliminated unchanged in urine in adults.

In two studies, after IV administration to pediatric patients ages 1-14 years, mean clearance values ranged from 1.01-

1.41L/kg/hr (range 0.32 -2.22 L/kg/hr). In adults, IV clearance values were 0.54 ±

0.14L/kg/hr. Pediatrics The estimated apparent clearance of glycopyrrolate from a popula… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 36 words ▾

12.1Mechanism of Action Glycopyrrolate is a competitive inhibitor of acetylcholine receptors that are located on certain peripheral tissues, including salivary glands. Glycopyrrolate indirectly reduces the rate of salivation by preventing the stimulation of these receptors.

📦 How Supplied / Storage and Handling 39 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING NDC 82983-428-47; 1 mg/5mL clear, cherry-flavored solution; 16 oz. bottle. Store at room temperature 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature].

📦 Storage and Handling 24 words ▾

Store at room temperature 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature].

📋 Description 80 words ▾

11 DESCRIPTION Glycopyrrolate Oral Solution is an anticholinergic drug available as an oral solution containing 1 mg glycopyrrolate per 5 mL. The chemical name for glycopyrrolate is pyrrolidinium, 3-[(cyclopentylhydroxyphenylacetyl) oxy]-1,1-dimethyl-,bromide. The chemical structure is: The empirical formula for Glycopyrrolate Oral Solution is C19H28BrNO3 and the molecular weight is 398.33.

The inactive ingredients in Glycopyrrolate Oral Solution are: anhydrous citric acid, glycerin, natural and artificial cherry flavor, methylparaben, propylene glycol, propylparaben, saccharin sodium, sodium citrate, sorbitol solution, and purified water. structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information) • Advise patients/caregivers to measure Glycopyrrolate Oral Solution with an accurate measuring device. A household teaspoon is not an accurate measuring device. Patients/caregivers should use a dosing cup available in pharmacies to accurately measure the correct milliliter dose.

An oral syringe, also available in pharmacies, should be used to dispense Glycopyrrolate Oral Solution into the child's mouth from the cup. A pharmacist can recommend an appropriate measuring device and can provide instructions for measuring the correct dose. • Administering Glycopyrrolate Oral Solution with a high fat meal substantially reduces the amount of glycopyrrolate absorbed. Administer Glycopyrrolate Oral Solution at least one hour before or two hours after meals. • Glycopyrrolate Oral Solution is started at a low dose and gradually titrated over a period of weeks based on therapeutic response and adverse reactions.

Patients/caregivers should not increase the dose without the physician's permission. • Common adverse reactions from Glycopyrrolate Oral Solution include overly dry mouth, constipation, vomiting, flushing of the skin or face, and urinary retention. Side effects can sometimes be difficult to detect in some patients with neurologic problems who cannot adequately communicate how they feel. If side effects become troublesome after increasing a dose, decrease the dose to the prior one and contact your physician. • Constipation is the most common side effect of glycopyrrolate, and if constipation occurs, stop administering glycopyrrolate to the patient and call their healthcare practitioner. • Inability of the patient to urinate, dry diapers or undergarments, irritability or crying may be signs of urinary retention, and if urinary retention occurs, patients/caregivers should stop administering glycopyrrolate and call their healthcare practitioner. • If the patient develops a skin rash, hives or an allergic reaction, patients/caregivers should stop administering glycopyrrolate and call their healthcare practitioner as this could be a sign of hypersensitivity to this product. • Drugs like glycopyrrolate can reduce sweating, and if the patient is in a hot environment and flushing of the skin occurs this may be due to overheating.

Avoid exposure of the patient to hot or very warm environmental temperatures to avoid overheating and the possibility of heat exhaustion or heat stroke.

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Absorption In a parallel study of children (n=6 per group) aged 7-14 years undergoing intraocular surgery, subjects received either intravenous (IV) or oral glycopyrrolate as a premedication. The mean absolute bioavailability of oral glycopyrrolate tablets was low (approximately 3%) and highly variable among subjects (range 1.3 to 13.3%). A similar pattern of low and variable relative bioavailability is seen in adults.

Analysis of population pharmacokinetic data from normal adults and children with cerebral palsy associated chronic moderate to severe drooling failed to demonstrate linear pharmacokinetics across the dose range. In the same analysis, population estimates of the apparent oral clearance (scaled by weight in children and adults) ranged from 5.28 -

38.95L/hr/kg for healthy adults and 8.07 -

25.65L/hr/kg for patients with cerebral palsy, a reflection of the low and highly variable oral bioavailability of glycopyrrolate. Absorption of Glycopyrrolate Oral Solution (fasting) was compared to that of a marketed glycopyrrolate oral tablet. The C max after oral solution administration was 23% lower compared to tablet administration and AUC 0-inf was 28% lower after oral solution administration.

Mean C max after oral solution administration in the fasting state was 0.318 ng/mL, and mean AUC 0-24 was 1.74 ng∙hr/mL. Mean time to maximum plasma concentration for Glycopyrrolate Oral Solution was 3.1 hours, and mean plasma half-life was 3.0 hours. In healthy adults, a high fat meal was shown to significantly affect the absorption of glycopyrrolate oral solution (10 mL, 1 mg/5 mL).

The mean C max under fed high fat meal conditions was approximately 74% lower than the C max observed under fasting conditions. Similarly, mean AUC 0-T was reduced by about 78% by the high fat meal compared with the fasting AUC 0-T . A high fat meal markedly reduces the oral bioavailability of Glycopyrrolate Oral Solution.

Therefore, Glycopyrrolate Oral Solution should be dosed at least one hour before or two hours after meals. Pharmacokinetic results (mean ± SD) are described in Table 3. Table 3: Pharmacokinetic Parameters (mean±SD) for Glycopyrrolate Oral Solution, Fasting and Fed, in Healthy Adults C max (ng/mL) T max (hrs) AUC 0-T (ng∙hr/mL) AUC 0-Inf (ng∙hr/mL) T 1/2 (hrs) Fasting (n=37) 0.318 ± 0.190 3.10 ± 1.08 1.74 ± 1.07 1.81 ± 1.09 3.0 ±

1.2Fed (n=36) 0.084 ± 0.081 2.60 ± 1.12 0.38 ± 0.14 0.46 ± 0.13 n=35 3.2 ±

1.1Distribution After IV administration, glycopyrrolate has a mean volume of distribution in children aged 1 to 14 years of approximately 1.3 to

1.8L/kg, with a range from 0.7 to

3.9L/kg. In adults aged 60-75 years, the volume of distribution was lower (0.42 L/kg +/- 0.22). Metabolism In adult patients who underwent surgery for cholelithiasis and were given a single IV dose of tritiated glycopyrrolate, approximately 85% of total radioactivity was excreted in urine and <5% was present in T-tube drainage of bile.

In both urine and bile, >80% of the radioactivity corresponded to unchanged drug. These data suggest a small proportion of IV glycopyrrolate is excreted as one or more metabolites. Elimination Approximately 65-80% of an IV glycopyrrolate dose was eliminated unchanged in urine in adults.

In two studies, after IV administration to pediatric patients ages 1-14 years, mean clearance values ranged from 1.01-

1.41L/kg/hr (range 0.32 -2.22 L/kg/hr). In adults, IV clearance values were 0.54 ±

0.14L/kg/hr. Pediatrics The estimated apparent clearance of glycopyrrolate from a population pharmacokinetic analysis (scaled by weight in children and adults) of oral and IV data was found to be

13.2 L/hr/kg or

92.7L/hr for a typical 70 kg subject. In the same population based analysis, gender was not identified as having an effect on either glycopyrrolate clearance or systemic exposure. Gender Population pharmacokinetic evaluation of adults and children administered IV or oral glycopyrrolate identified no effect of g… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 17 words ▾

12.2Pharmacodynamics Glycopyrrolate inhibits the action of acetylcholine on salivary glands thereby reducing the extent of salivation.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES Glycopyrrolate Oral Solution was evaluated in a multi-center, randomized, double-blind, placebo-controlled, parallel, eight-week study for the control of pathologic drooling in children (Study 1). The study enrolled 38 subjects aged 3-23 years; thirty-six subjects were aged 3-16 years and two patients were greater than 16 years. The subjects were male or female, weighed at least 13 kg (27 lbs), and had cerebral palsy, mental retardation, or another neurologic condition associated with problem drooling defined as drooling in the absence of treatment so that clothing became damp on most days (approximately five to seven days per week).

Subjects were randomized in a 1:1 fashion to receive Glycopyrrolate Oral Solution or placebo. Doses of study medication were titrated over a 4-week period to optimal response beginning at 0.02 mg/kg three times a day increasing doses in increments of approximately 0.02 mg/kg three times per day every 5-7 days, not to exceed the lesser of approximately 0.1 mg/kg three times per day or 3 mg three times per day. Subjects were evaluated on the 9-point modified Teacher's Drooling Scale (mTDS), which is presented below.

The mTDS evaluations were recorded by parents/caregivers 3 times daily approximately two hours post-dose on evaluation days during pre-treatment baseline and at Weeks 2, 4, 6 and 8 of therapy. Modified Teacher's Drooling Scale 1= Dry: never drools 2= Mild: only the lips are wet; occasionally 3= Mild: only the lips are wet; frequently 4= Moderate: wet on the lips and chin; occasionally 5= Moderate: wet on the lips and chin; frequently 6= Severe: drools to the extent that clothing becomes damp; occasionally 7= Severe: drools to the extent that clothing becomes damp; frequently 8= Profuse: clothing, hands, tray, and objects become wet; occasionally 9= Profuse: clothing, hands, tray, and objects become wet; frequently Responders were defined as subjects with at least a 3-point reduction in mean daily mTDS scores from baseline to Week 8.

Table 4 presents the proportion of responders at Week 8 and Figure 1 presents the mean mTDS values from baseline through Week 8. Table 4: Percentage of Responders at Week 8 Glycopyrrolate Oral Solution Group (N=20) Placebo Group (N=18) 15/20 (75%) 2/18 (11%) Figure 1. Mean (± 2 Standard Errors) mDTS Scores figure1

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility When glycopyrrolate was administered via oral gavage to mice for up to 24 months at dosages of 2.5, 7, and 20 mg/kg/day in both genders, resulting in systemic exposures (estimated AUC 0-inf values) approximately 0.1, 0.3, and 0.8 times, respectively, the estimated systemic exposure in humans at the MRHD (9 mg per day, administered in three divided doses), no significant changes in tumor incidence were observed when compared to control. When glycopyrrolate was administered via oral gavage to rats for up to 24 months at dosages of 5, 15, and 40 mg/kg/day in both genders, resulting in systemic exposures approximately 0.2, 0.8, and 2 times, respectively, the estimated systemic exposure in humans at the MRHD, no significant changes in tumor incidence were observed when compared to control.

Glycopyrrolate did not elicit any genotoxic effects in the Ames mutagenicity assay, the human lymphocyte chromosome aberration assay, or the micronucleus assay. Glycopyrrolate was assessed for effects on fertility or general reproductive function in rats. Rats of both genders received glycopyrrolate at dosages up to 100 mg/kg/day via oral gavage, resulting in systemic exposures (estimated AUC 0-inf values) in males and females up to approximately 11 and 15 times, respectively, the estimated systemic exposure in humans at the MRHD.

No treatment-related effects on fertility or reproductive parameters were observed in either gender in this study.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility When glycopyrrolate was administered via oral gavage to mice for up to 24 months at dosages of 2.5, 7, and 20 mg/kg/day in both genders, resulting in systemic exposures (estimated AUC 0-inf values) approximately 0.1, 0.3, and 0.8 times, respectively, the estimated systemic exposure in humans at the MRHD (9 mg per day, administered in three divided doses), no significant changes in tumor incidence were observed when compared to control. When glycopyrrolate was administered via oral gavage to rats for up to 24 months at dosages of 5, 15, and 40 mg/kg/day in both genders, resulting in systemic exposures approximately 0.2, 0.8, and 2 times, respectively, the estimated systemic exposure in humans at the MRHD, no significant changes in tumor incidence were observed when compared to control.

Glycopyrrolate did not elicit any genotoxic effects in the Ames mutagenicity assay, the human lymphocyte chromosome aberration assay, or the micronucleus assay. Glycopyrrolate was assessed for effects on fertility or general reproductive function in rats. Rats of both genders received glycopyrrolate at dosages up to 100 mg/kg/day via oral gavage, resulting in systemic exposures (estimated AUC 0-inf values) in males and females up to approximately 11 and 15 times, respectively, the estimated systemic exposure in humans at the MRHD.

No treatment-related effects on fertility or reproductive parameters were observed in either gender in this study.

📄 Patient Package Insert ~3 min read ▾

PATIENT and CAREGIVER INFORMATION Glycopyrrolate Oral Solution Please read the Patient and Caregiver Information that comes with Glycopyrrolate Oral Solution before you start giving it to your child, and each time you get a refill. This leaflet does not take the place of talking with your doctor about your child's medical condition or treatment. What is Glycopyrrolate Oral Solution?

Glycopyrrolate Oral Solution is a prescription medicine used in children with medical conditions that cause too much (abnormal) drooling. Who should not take Glycopyrrolate Oral Solution? Do not give Glycopyrrolate Oral Solution to anyone who: • has problems urinating • has a bowel problem called paralytic ileus • lacks normal bowel tone or tension • has severe ulcerative colitis or certain other serious bowel problems with severe ulcerative colitis • has myasthenia gravis What should I tell my doctor before giving Glycopyrrolate Oral Solutionto my child?

Tell your doctor if your child: • has any allergies • has any stomach or bowel problems, including ulcerative colitis • has any problems with constipation • has thyroid problems • has high blood pressure • has heart problems or abnormal heart beats • has a hiatal hernia with gastroesophageal reflux disease (GERD) • has any eye problems • has any problems urinating • has any other medical conditions • is pregnant or plans to become pregnant. It is not known if Glycopyrrolate Oral Solution can harm an unborn baby. • is breastfeeding or plans to breastfeed.

It is not known if Glycopyrrolate Oral Solution passes into breast milk and if it can harm the baby. Tell your doctor about all of the medicines that your child takes , including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicine may affect the way Glycopyrrolate Oral Solution works, and Glycopyrrolate Oral Solution may affect how some other medicines work.

How should I give Glycopyrrolate Oral Solution? • Give Glycopyrrolate Oral Solution exactly as prescribed by your child's doctor. • Give Glycopyrrolate Oral Solution 1 hour before or 2 hours after meals. • Your doctor will tell you how much (milliliters or mLs) of Glycopyrrolate Oral Solution to give your child. • Do not change the dose of Glycopyrrolate Oral Solution unless your doctor tells you to. • You must measure the dose of Glycopyrrolate Oral Solution before giving it to your child. Use a special marked dose measuring cup (available at most pharmacies) to measure the right dose of Glycopyrrolate Oral Solution. • To help make sure that your child swallows the dose, you should use an oral syringe to give the child each dose of Glycopyrrolate Oral Solution, after you measure the dose needed with a dose measuring cup.

Oral syringes are also available at most pharmacies. • If you have questions about how to measure the dose or how to use an oral syringe, ask your pharmacist or doctor. • The dose of Glycopyrrolate Oral Solution that is needed to control drooling may be different for each child. Glycopyrrolate Oral Solution is usually started at a low dose, and slowly increased as directed by your doctor. This slow increase in dose continues until the best dose for your child is reached, to control drooling. • During this time it is important to stay in close contact with your child's doctor, and tell the doctor about any side effects that your child has.

See " What are the possible side effects of Glycopyrrolate Oral Solution ?" What should I avoid while taking Glycopyrrolate Oral Solution? • Glycopyrrolate Oral Solution may cause sleepiness or blurred vision. Do not drive a car, operate heavy machinery, or do other dangerous activities while taking Glycopyrrolate Oral Solution. • Avoid overheating. See " What are the possible side effects of Glycopyrrolate Oral Solution ?" What are the possible side effects of Glycopyrrolate Oral Solution?

Glycopyrrolate Oral Solution can cause serious side effects including: • Constipation. Constipation is common wi… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 25 words ▾

PACKAGE LABEL PRINCIPAL DISPLAY PANEL Label: Glycopyrrolate Oral Solution - Label 1 mg/5 mL (0.2 mg/mL) For Oral Use Only NDC 82983-428-47 Rx Only label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Glycopyrrolate (matched by generic name) — the program that covers self-administered drugs. 18 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Glycopyrrolate. CMS lists 3 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$2.44M
Claims incl. refills
67.4K
Beneficiaries
34.1K
Spend / beneficiary
$71.59
Spend / claim
$36.23
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by AJENAT PHARMACEUTICALS LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
AJENAT PHARMACEUTICALS LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 82983-0427-31 · Ajenat 82983-0429-30 · AJENAT →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.