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GLYCOPYRROLATE 2 mg Tablet, 100-count — NDC 69076-0476-01 package photo

GLYCOPYRROLATE 2 mg Tablet, 100-count

by Quinn Pharmaceuticals · 100 TABLET in 1 BOTTLE (69076-476-01)
NDC 69076-0476-01
🏷️ FDA NDC (as labeled) 69076-476-01 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
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

FDA NDC (as labeled) 69076-476-01
Product NDC 69076-476
11-digit billing NDC 69076047601
NCPDP billing unit EA — each (per item)
RxCUI 197738, 197739
UNII V92SO9WP2I
UPC 0369076475014, 0369076476011
Application # ANDA091182
SPL Set ID e1ded8e0-c05b-4bf4-a129-57d1726af6ed
Established class (EPC) Anticholinergic
Mechanism of action Cholinergic Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-05-01
Route ORAL
Dosage form TABLET
Substance GLYCOPYRROLATE
GPI-14 49102030000315
GPI class Glycopyrrolate
GCN Seq No 004888
GCN 19131
HICL code 002028
Ingredient (HICL) Glycopyrrolate
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J2
Therapeutic class — intermediate (HIC2) Anticholinergics
HIC3 code J2B
Therapeutic class — specific (HIC3) Anticholinergics,Quaternary Ammonium
AHFS code 12:08.08.00
AHFS class Antimuscarinics/Antispasmodics
FDB label name GLYCOPYRROLATE 2 MG TABLET
FDB brand name Glycopyrrolate
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AA · RLD · RS
Why two NDCs? The FDA registers this code as 69076-476-01 — 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 → 69076-0476-01. 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.

🏭 Manufacturer & labeler

LabelerQuinn Pharmaceuticals
Application holderREGCON HOLDINGS LLC
FDA applicationANDA091182 (ANDA)
Labeler code69076
First marketedMay 2021
Product typeHuman Prescription Drug
Portfolio4 products on file
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.

🩺 Clinical

Label name GLYCOPYRROLATE 2 MG TABLET Ingredient Glycopyrrolate
📖 What it is MedlinePlus · NLM

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 ↗
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.

💊 What it looks like

Color white
ShapeRound
Imprint0476
Size1 mm
ScoringScored — splits in 2
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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • 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.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

4 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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

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.

💲 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 eaPer package
Retail pharmacies payNADAC · weekly $0.147 $14.72 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.3342 $33.42 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.1993 $19.93 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.322 $0.146
▼ Down 10% over the last 24 months.
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice 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 mgthis 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 mg 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 —
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

🏛️
2021
On the market since
May 2021
📍
2026
Currently FDA-listed
5 years 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 69076-0476-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
2.9K
Units reimbursed last 4 qtrs
215.1K
Gross reimbursed last 4 qtrs
$71.9K
Avg / prescription
$25.19
Avg / unit
$0.3342
Latest quarter Q4 2025
548Rx
Medicaid pays / ea
$0.3342
gross reimbursed
vs
NADAC / ea
$0.1472
acquisition cost
=
Spread
+$0.1870
+127% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
42% FFS 58% MCO
Fee-for-service · 1,207 Rx Managed care · 1,646 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 10,198 units · 131 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 2,929 units · 49.6 per 100k residents WI Michigan: 6,130 units · 61.1 per 100k residents MI New York: 37,408 units · 191 per 100k residents NY Vermont: 3,518 units · 544 per 100k residents VT New Hampshire: 3,675 units · 262 per 100k residents NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 1,492 units · 46.5 per 100k residents IA Illinois: 2,297 units · 18.3 per 100k residents IL Indiana: no data reported IN Ohio: 3,848 units · 32.7 per 100k residents OH Pennsylvania: 25,141 units · 194 per 100k residents PA New Jersey: 4,260 units · 45.9 per 100k residents NJ Massachusetts: no data reported MA California: 29,053 units · 74.6 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 1,950 units · 43.1 per 100k residents KY West Virginia: no data reported WV Virginia: 2,168 units · 24.9 per 100k residents VA Maryland: 720 units · 11.7 per 100k residents MD Connecticut: 3,652 units · 101 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 7,152 units · 100 per 100k residents TN North Carolina: 8,344 units · 77.0 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: 645 units · 12.6 per 100k residents AL Georgia: 7,997 units · 72.5 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 34,981 units · 115 per 100k residents TX Florida: 17,518 units · 77.5 per 100k residents FL
Units reimbursed · per 100k residents
11.7544
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Vermont 544 /100k
2 New Hampshire 262 /100k
3 Pennsylvania 194 /100k
4 New York 191 /100k
5 Washington 131 /100k
6 Texas 115 /100k
7 Connecticut 101 /100k
8 Tennessee 100 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for Glycopyrrolate — 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. 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Glycopyrrolate — the ingredient across all brands.

Top reported reactions

Dyspnoea3,566
Cough1,693
Device Delivery System Issue1,666
Death1,631
Asthma1,478
Wrong Technique In Device Usage Process1,317
Chronic Obstructive Pulmonary Disease1,210

Age at onset

Neonate23
Infant13
Child55
Adolescent26
Adult1,670
Elderly2,451

Reporter sex

19,422 reports
Male · 43%
Female · 57%
Unknown · 0%

Serious outcomes

Hospitalization4,741
Death2,286
Life-threatening641
Disabling296
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4,124 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
69076-0476-01 You're viewing this 100 TABLET in 1 BOTTLE (69076-476-01) 2021-05-01 Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 14 words ▾

INDICATIONS AND USAGE For use as adjunctive therapy in the treatment of peptic ulcer.

⏱️ Dosage and Administration 147 words ▾

DOSAGE AND ADMINISTRATION The dosage of Glycopyrrolate Tablets, USP 1 mg and 2 mg 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, USP 1 mg The recommended initial dosage of Glycopyrrolate Tablets, USP 1 mg 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, USP 2 mg The recommended dosage of Glycopyrrolate Tablets, USP 2 mg 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.

⛔ Contraindications 64 words ▾

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, USP are contraindicated in those patients with a hypersensitivity to glycopyrrolate.

⚠️ Warnings ~1 min read ▾

WARNINGS In the presence of a high environmental temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with the use of Glycopyrrolate. 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 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 76 words ▾

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.

🔄 Drug Interactions 8 words ▾

DRUG INTERACTIONS There are no known drug interactions.

🤰 Pregnancy 136 words ▾

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.

🧒 Pediatric Use 26 words ▾

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.

🆘 Overdosage 72 words ▾

OVERDOSAGE The symptoms of overdosage of glycopyrrolate are peripheral in nature rather than central. To guard against further absorption of the drug-use gastric avage, cathartics and/or enemas. To combat peripheral anticholinergic effects (residual mydriasis, dry mouth, etc.)-utilize a quaternary ammonium anticholinesterase, such as neostigmine methylsulfate.

To combat hypotension-use pressor amines (norepinephrine, metaraminol) i.v.; and supportive care. To combat respiratory depression-administer oxygen; utilize a respiratory stimulant such as Dopram ® i.v.; artificial respiration.

🧬 Clinical Pharmacology 140 words ▾

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 135 words ▾

HOW SUPPLIED Glycopyrrolate Tablets, USP 1 mg are uncoated, round, flat face white tablets with beveled edge and debossed with “0475” on one side and bisected on the other. Glycopyrrolate Tablets, USP 1 mg in bottles of 100 (NDC 69076-475-01). Glycopyrrolate Tablets, USP 2 mg are uncoated, round, flat face white tablets with beveled edges and debossed with “0476” on one side and bisected on the other.

Glycopyrrolate Tablets, USP 2 mg in bottles of 100 (NDC 69076-476-01). Store at controlled room temperature, 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C-30°C (59°F-86°F) [See USP Controlled Room Temperature]. Keep out of reach of children.

Dispense in tight container. Rx only Manufactured by: Contract Pharmacal Corp. 165 Oser Avenue Hauppauge, NY 11788 Distributed by: Quinn Pharmaceuticals 954-755-0502 www.quinnrx.com Made in USA Rev: 03/2021 (4) R50242

📋 Description 103 words ▾

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. Each glycopyrrolate tablet USP, intended for oral administration, contains glycopyrrolate equivalent to 1 mg or 2 mg.

In addition, it also contains the following inactive ingredients: lactose monohydrate, dibasic calcium phosphate anhydrous, povidone, sodium starch glycolate and magnesium stearate. The structural formula of glycopyrrolate is represented below: Molecular Formula: C 19 H 28 BrNO 3 Molecular Weight: 398.33 Each tablet contains 1 mg or 2 mg of Glycopyrrolate, USP. Inactive Ingredients: Microcrystalline cellulose, lactose monohydrate, pregelatinized starch, magnesium stearate Chemical Structure

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 69076-0475-01 · Quinn 69079-0152-10 · Titan →
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.