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Trospium Chloride 20 mg Tablet, Film Coated, 2,400-count — NDC 71610-812-87 (Billing 71610-0812-87)

by Aphena Pharma Solutions - Tennessee, LLC · 2400 TABLET, FILM COATED in 1 BOTTLE

This is a package of 2,400 tablets of Trospium Chloride 20 mg Tablet, Film Coated from Aphena Pharma Solutions - Tennessee, LLC, marketed since Nov 2015 and currently FDA-listed. It is this product's only package size.

NDC 71610-0812-87
🏷️ FDA NDC (as labeled) 71610-812-87 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 71610-812-87 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
71610 labeler · 812 product · 87 package
Package marketed since
Mar 28, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
2,400 EA per package
Barcode (UPC-A, from the NDC)
3 7161081287 2
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Trospium Chloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Nov 1, 2023 — Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules (Padagis US LLC) · FDA recall D-0139-2024
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) 71610-812-87
Product NDC 71610-812
11-digit billing NDC 71610081287
NCPDP billing unit EA — each (per item)
RxCUI 857560
UNII 1E6682427E
Application # ANDA204945
SPL Set ID 1523cb4c-3a52-6c18-e063-6394a90a396f
Established class (EPC) Cholinergic Muscarinic Antagonist
Mechanism of action Cholinergic Muscarinic Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-11-16
Route ORAL
Dosage form TABLET, FILM COATED
Substance TROSPIUM CHLORIDE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 038085
GCN 08744
HICL code 017498
Ingredient (HICL) Trospium Chloride
HIC1 code R
Therapeutic class — broad (HIC1) Kidney/Urinary Tract
HIC2 code R1
Therapeutic class — intermediate (HIC2) Affect Primarily Kidneys/Urinary Tract
HIC3 code R1A
Therapeutic class — specific (HIC3) Urinary Tract Antispasmodic/Antiincontinence Agent
AHFS code 86:12.04.00
AHFS class Antimuscarinics
FDB label name TROSPIUM CHLORIDE 20 MG TABLET
FDB brand name Trospium Chloride
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 038085
  • GCN: 08744
  • HICL (First Databank): 017498
  • AHFS class code: 86:12.04.00
  • RxCUI (RxNorm): 857560
Why two NDCs? The FDA registers this code as 71610-812-87 — 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 → 71610-0812-87. 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 Cholinergic Muscarinic Antagonist class.

Pharmacologic class Cholinergic Muscarinic Antagonist
Drug family (ATC) Drugs for urinary frequency and incontinence, Other antipsychotics
How it works Cholinergic Muscarinic 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

Label name TROSPIUM CHLORIDE 20 MG TABLET Ingredient Trospium Chloride
📗 Our plain-language guide HelloPharmacist
  • Trospium treats overactive bladder. That means sudden urges to urinate, leaking with those urges, and going often. It calms the bladder muscle to help with those symptoms.
  • Take it with water on an empty stomach, at least an hour before a meal. The tablets are usually taken twice a day, and the extended-release capsules once in the morning. Follow the...
  • Dry mouth and constipation are the most common, and they often show up in the first week. Dry eyes, gas, nausea, and stomach upset can also happen. Tell me or your doctor if they b...
  • Get emergency help right away if your face, lips, tongue, or throat swells. Call your doctor if you can't urinate, can't pass stool, or feel confused, see things that aren't there,...
📖 Read our full Trospium guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 eachPer 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 $0.4656 $1,117.44 / 2400 tablets
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
71610-0812-87 You're viewing this Main listing 2400 TABLET, FILM COATED in 1 BOTTLE 2024-03-28 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Trospium Chloride 20 mg 00574-0145-60 Padagis 60 tablets $0.211 AB Availability likely —
Trospium Chloride 20 mg 00904-7059-52 Major 60 tablets $0.211 AB Availability likely —
Trospium Chloride 20 mg 33342-0554-09 Macleods 60 tablets $0.211 AB Availability likely —
Trospium Chloride 20 mg 62135-0742-60 Chartwell 60 tablets $0.211 AB Availability likely —
Trospium Chloride 20 mg 76282-0336-60 Exelan 60 tablets $0.211 AB Availability likely —
Trospium Chloride 20 mg 90096-0141-60 Zameer 60 tablets $0.211 AB Availability likely —
Trospium Chloride 20 mg 23155-0530-02 Heritage 200 tablets — AB FDA listed —
Trospium Chloride 20 mg 63629-8457-01 Bryant 60 tablets — AB FDA listed —
Trospium Chloride 20 mg 63629-9279-01 Bryant 60 tablets — AB FDA listed —
Trospium Chloride 20 mg 68462-0461-05 Glenmark 500 tablets — AB FDA listed —
Trospium Chloride 20 mg 69097-0912-02 CIPLA 30 tablets — AB FDA listed —
Trospium Chloride 20 mg 70518-4593-00 REMEDYREPACK 1 tablet — AB FDA listed —
Trospium Chloride 20 mg 71335-2961-01 Bryant 60 tablets — AB FDA listed —
Trospium Chloride 20 mgthis 71610-0812-87 Aphena 2400 tablets — AB FDA listed —
Trospium Chloride 20 mg 72162-1108-06 Bryant 60 tablets — AB FDA listed —
Trospium Chloride 20 mg 72789-0348-60 PD-Rx 60 tablets — AB FDA listed —
Trospium Chloride 20 mg 00904-7619-40 MAJOR 500 tablets — AB 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

🏛️
2015
On the market since
Nov 2015
📍
2026
Currently FDA-listed
11 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.

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

LabelerAphena Pharma Solutions - Tennessee, LLC
Application holderHERITAGE PHARMACEUTICALS INC
FDA applicationANDA204945 (ANDA)
Labeler code71610
First marketedNov 2015
Product typeHuman Prescription Drug
Portfolio800 products on file

More NDCs from Aphena Pharma Solutions - Tennessee, LLC labeler code 71610

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 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 57 words ▾

1 INDICATIONS AND USAGE Trospium chloride tablets are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. Trospium chloride tablets are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. ( 1 )

⏱️ Dosage and Administration 207 words ▾

2 DOSAGE AND ADMINISTRATION The recommended dose is 20 mg twice daily. Trospium chloride tablets should be dosed at least one hour before meals or given on an empty stomach. Dosage modification is recommended in the following patient populations: For patients with severe renal impairment (creatinine clearance less than 30 mL/min), the recommended dose is 20 mg once daily at bedtime [ see Warnings and Precautions ( 5.5 ), Use in Specific Populations ( 8.6 ), and Clinical Pharmacology ( 12.3 ) ].

In geriatric patients greater than or equal to 75 years of age, dose may be titrated down to 20 mg once daily based upon tolerability [ see Use in Specific Populations ( 8.5 ) ]. The recommended dose of trospium chloride tablet is one 20 mg tablet twice daily. Trospium chloride tablets should be dosed with water on an empty stomach, at least one hour before a meal.

( 2 ) For patients with severe renal impairment (creatinine clearance less than 30 mL/min), the recommended dose is 20 mg once daily at bedtime. ( 2 ) In geriatric patients greater than or equal to 75 years of age, dose may be titrated down to 20 mg once daily based upon tolerability. ( 2 )

💊 Dosage Forms and Strengths 42 words ▾

3 DOSAGE FORMS AND STRENGTHS Trospium chloride tablets are supplied as 20 mg tablets (round, white to off white, film coated tablets. Imprinted "HP" with black ink on one side and "530" on the reverse side). 20 mg tablets. ( 3 )

⛔ Contraindications 69 words ▾

4 CONTRAINDICATIONS Trospium chloride tablets are contraindicated in patients with: urinary retention gastric retention uncontrolled narrow-angle glaucoma. known hypersensitivity to the drug or its ingredients. Angioedema, rash and anaphylactic reaction have been reported. Trospium chloride tablets are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma, and in patients who are at risk for these conditions ( 4 ) patients with known hypersensitivity ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Trospium chloride tablets should be administered with caution to patients with clinically significant bladder outflow obstruction or gastrointestinal obstructive disorders due to risk of urinary or gastric retention. ( 5.1 , 5.3 ) Angioedema of the face, lips, tongue and/or larynx has been reported with trospium chloride. ( 5.2 ) In patients with controlled narrow angle glaucoma trospium chloride should be used only with careful monitoring.

( 5.4 ) Central Nervous System Effects: Somnolence has been reported with trospium chloride. Advise patients not to drive or operate heavy machinery until they know how trospium chloride affects them. ( 5.5 ) Trospium is substantially excreted by the kidney.

The effects of moderate renal impairment on systemic exposure are not known but systemic exposure is likely increased. Therefore, the risk of anticholinergic adverse reactions is expected to be greater in patients with moderate renal impairment. ( 5.6 )

5.1Risk of Urinary Retention Trospium chloride tablets should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention [ see Contraindications ( 4 ) ].

5.2Angioedema Angioedema of the face, lips, tongue, and/or larynx has been reported with trospium chloride, the active ingredient in trospium chloride tablets. In one case, angioedema occurred after the first dose of trospium chloride. Angioedema associated with upper airway swelling may be life threatening.

If involvement of the tongue, hypopharynx, or larynx occurs, trospium chloride should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided.

5.3Decreased Gastrointestinal Motility Trospium should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention [ see Contraindications ( 4 ) ]. Trospium chloride, like other antimuscarinic agents, may decrease gastrointestinal motility and should be used with caution in patients with conditions such as ulcerative colitis, intestinal atony and myasthenia gravis.

5.4Controlled Narrow-angle Glaucoma In patients being treated for narrow-angle glaucoma, trospium chloride should only be used if the potential benefits outweigh the risks and in that circumstance only with careful monitoring [ see Contraindications ( 4 ) ].

5.5Central Nervous System Effects Trospium chloride is associated with anticholinergic central nervous system (CNS) effects [ see Adverse Reactions ( 6.2 ) ]. A variety of CNS anticholinergic effects have been reported, including dizziness, confusion, hallucinations and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing the dose.

Advise patients not to drive or operate heavy machinery until they know how trospium chloride affects them. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered.

5.6Anticholinergic Adverse Reactions in Patients with Moderate Renal Impairment Trospium is substantially excreted by the kidney. The effects of moderate renal impairment on systemic exposure are not known but systemic exposure is likely increased. Therefore, anticholinergic adverse reactions (including dry mouth, constipation, dyspepsia, urinary tract infection, and urinary retention) are expected to be greater in patients with moderate renal impairment [ see Dosage and Administration ( 2 ), and Use in Specific Populations ( 8.6 ) ].

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The most common adverse reactions (greater than or equal to 1%) with trospium chloride are dry mouth (20.1%), constipation (9.6%), and headache (4.2%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) 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, the 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 clinical practice. The safety of trospium chloride was evaluated in controlled clinical trials in a total of 2975 patients, who were treated with trospium chloride (N=1673), placebo (N=1056) or active control medications (N=246). Of this total, 1181 patients participated in two, 12-week, U.S., efficacy and safety studies and a 9-month open-label extension.

Of this total, 591 patients received trospium chloride tablets 20 mg twice daily. In all controlled trials combined, 232 and 208 patients received treatment with trospium chloride for at least 24 and 52 weeks, respectively. In all placebo-controlled trials combined, the incidence of serious adverse events was 2.9% among patients receiving trospium chloride tablets 20 mg twice daily and 1.5% among patients receiving placebo.

Table 1 lists adverse reactions from the combined 12-week U.S. safety and efficacy trials were reported by at least 1% of patients, and were reported more frequently in the trospium chloride group than in the placebo group. The two most common adverse reactions reported by patients receiving trospium chloride tablets 20 mg twice daily were dry mouth and constipation. The single most frequently reported adverse reaction for trospium chloride tablets, dry mouth, occurred in 20.1% of trospium chloride treated patients and 5.8% of patients receiving placebo.

In the two U.S. studies, dry mouth led to discontinuation in 1.9% of patients treated with trospium chloride tablets 20 mg twice daily. For the patients who reported dry mouth, most had their first occurrence of the event within the first month of treatment. Table 1.

Incidence (%) of adverse reactions with trospium chloride, reported in greater than or equal to 1% of all patients treated with trospium chloride tablets and more frequent with trospium chloride tablets (20 mg twice daily) than placebo in Studies 1 and 2 combined Adverse Reaction Placebo (N=590) Trospium Chloride Tablets 20 mg twice daily (N=591) Gastrointestinal Disorders Dry mouth 34 (5.8) 119 (20.1) Constipation 27 (4.6) 57 (9.6) Abdominal pain upper 7 (1.2) 9 (1.5) Constipation aggravated 5 (0.8) 8 (1.4) Dyspepsia 2 (0.3) 7 (1.2) Flatulence 5 (0.8) 7 (1.2) Nervous System Disorders Headache 12 (2.0) 25 (4.2) General Disorders Fatigue 8 (1.4) 11 (1.9) Renal and Urinary Disorders Urinary retention 2 (0.3) 7 (1.2) Eye Disorders Dry eyes 2 (0.3) 7 (1.2) Other adverse reactions from the U.S., placebo-controlled trials, occurring in greater than or equal to 0.5% and less than 1.0% of patients treated with trospium chloride, and more common with trospium chloride than placebo are: tachycardia, vision blurred, abdominal distension, vomiting, dysgeusia, dry throat, and dry skin.

During controlled clinical studies, one adverse reaction of angioneurotic edema was reported.

6.2Post-marketing Experience The following adverse reactions have been identified during post-approval use of trospium chloride. 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. Gastrointestinal – gastritis; Cardiovascular – palpitations, supraventricular tachycardia, chest pain, syncope, "hypertensive crisis"; Immunological – Stevens-Johnson syndrome, anaphylactic reaction, angioedema; Nervous System – dizziness, confusion,… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Concomitant use with digoxin did not affect the pharmacokinetics of either drug. ( 7.1 ) Some drugs which are actively secreted by the kidney may interact with trospium chloride by competing for renal tubular secretion. ( 7.2 ) Concomitant use with metformin immediate release tablets reduced exposure and peak concentration of trospium. ( 7.4 )

7.1Digoxin Concomitant use of trospium chloride and digoxin did not affect the pharmacokinetics of either drug [ see Clinical Pharmacology ( 12.3 ) ].

7.2Drugs Eliminated by Active Tubular Secretion Although demonstrated in a drug-drug interaction study not to affect the pharmacokinetics of digoxin, trospium chloride has the potential for pharmacokinetic interactions with other drugs that are eliminated by active tubular secretion (e.g., procainamide, pancuronium, morphine, vancomycin, and tenofovir). Coadministration of trospium chloride with these drugs may increase the serum concentration of trospium chloride and/or the coadministered drug due to competition for this elimination pathway.

Careful patient monitoring is recommended in patients receiving such drugs [ see Clinical Pharmacology ( 12.3 ) ].

7.3Antimuscarinic Agents The concomitant use of trospium chloride with other antimuscarinic agents that produce dry mouth, constipation, and other anticholinergic pharmacological effects may increase the frequency and/or severity of such effects. Trospium chloride may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility.

7.4Metformin Co-administration of 500 mg metformin immediate release tablets twice daily with SANCTURA XR ®+ (trospium chloride 60 mg extended release capsules) reduced the steady-state systemic exposure of trospium by approximately 29% for mean AUC 0-24 and by 34% for mean C max [ see Clinical Pharmacology ( 12.3 ) ].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS The safety and effectiveness of trospium chloride in pediatric patients have not been established. ( 8.4 )

8.1Pregnancy Teratogenic Effects Pregnancy Category C: There are no adequate and well-controlled studies of trospium chloride in pregnant women. Trospium chloride should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the patient and fetus. Women who become pregnant during trospium chloride treatment are encouraged to contact their physician.

Risk Summary Based on animal data, trospium chloride is predicted to have a low probability of increased risk of adverse developmental outcomes, above background risk. Adverse developmental findings were not observed to correlate with dose in rats or in rabbits. No increased risk above background was observed in rats and rabbits treated at an exposure approximately equivalent to the maximal recommended human dose (MRHD) of 40 mg.

Animal Data In a rat embryo/fetal development study, pregnant rats received doses of trospium chloride up to 200 mg/kg/day, from implantation to closure of the fetal hard palate, with maternal systemic exposures corresponding to approximately nine times the exposure of women treated at the MRHD of 40 mg, based on AUC. No malformations or fetal toxicity were observed. The offspring of female rats exposed orally, pre- and post-natally, to trospium chloride up to 200 mg/kg/day showed no increased developmental toxicity over background in surviving pups.

However, maternal toxicity (death, irregular breathing, increased excitability) was observed at 200 mg/kg/day. A no-effect level for maternal and pup toxicity (survival to Day 4) was 20 mg/kg/day, an exposure approximately equivalent to the maximal recommended human dose (MRHD) of 40 mg. In a rabbit embryo/fetal development study, pregnant rabbits received doses of trospium chloride up to 200 mg/kg/day, from implantation to closure of the fetal hard palate.

At 200 mg/kg/day, maternal systemic exposures corresponded to approximately 16 times the exposure of women treated at the MRHD of 40 mg, based on AUC. However, one fetus in each of the three treated dose groups (0.3 to 16 times exposures at the MRHD) demonstrated multiple malformations, including umbilical hernia and skeletal malformations. A maternal no-effect level was set at 20 mg/kg/day, at an exposure approximately equivalent to the maximal recommended human dose (MRHD) of 40 mg, due to clinical signs (reduced feces, hunched posture, diarrhea) observed in a pharmacokinetic study at 200 mg/kg/day.

8.2Labor and Delivery The effect of trospium chloride tablets on labor and delivery is unknown.

8.3Nursing Mothers Trospium chloride (2 mg/kg orally and 50 mcg/kg intravenously) was excreted, to a limited extent (less than 1%), into the milk of lactating rats (primarily as parent compound). It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, trospium chloride should be used during lactation only if the potential benefit justifies the potential risk to the newborn.

8.4Pediatric Use The safety and effectiveness of trospium chloride in pediatric patients have not been established.

8.5Geriatric Use Of the 591 patients with overactive bladder who received treatment with trospium chloride in the two U.S., placebo-controlled, efficacy and safety studies, 249 patients (42%) were 65 years of age and older. Eighty-eight trospium chloride treated patients (15%) were greater than or equal to 75 years of age. In these 2 studies, the incidence of commonly reported anticholinergic adverse reactions in patients treated with trospium chloride (including dry mouth, constipation, dyspepsia, urinary tract infection, and urinary retention) was higher in patients 75 years of age and older as compared to younger patients.

This effect may be related to an enhanced sensitivity to anticholinergic agents in this patient population [ see Clinical Pharmacolo… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 111 words ▾

10 OVERDOSAGE Overdosage with antimuscarinic agents, including trospium chloride, can result in severe antimuscarinic effects. Supportive treatment should be provided according to symptoms. In the event of overdosage, electrocardiographic monitoring is recommended.

A 7-month-old baby experienced tachycardia and mydriasis after administration of a single dose of trospium 10 mg given by a sibling. The baby's weight was reported as 5 kg. Following admission into the hospital and about 1 hour after ingestion of the trospium, medicinal charcoal was administered for detoxification.

While hospitalized, the baby experienced mydriasis and tachycardia up to 230 beats per minute. Therapeutic intervention was not deemed necessary. The baby was discharged as completely recovered the following day.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Trospium chloride is a muscarinic antagonist. Trospium chloride antagonizes the effect of acetylcholine on muscarinic receptors in cholinergically innervated organs including the bladder. Its parasympatholytic action reduces the tonus of smooth muscle in the bladder.

Receptor assays showed that trospium chloride has negligible affinity for nicotinic receptors as compared to muscarinic receptors at concentrations obtained from therapeutic doses.

12.2Pharmacodynamics Placebo-controlled studies employing urodynamic variables were conducted in patients with conditions characterized by involuntary detrusor contractions. The results demonstrate that trospium chloride increases maximum cystometric bladder capacity and volume at first detrusor contraction. Electrophysiology The effect of 20 mg twice daily and up to 100 mg twice daily of trospium chloride on QT interval was evaluated in a single-blind, randomized, placebo and active (moxifloxacin 400 mg once daily) controlled 5 day parallel trial in 170 male and female healthy volunteer subjects aged 18 to 45 years.

The QT interval was measured over a 24-hour period at steady state. The 100 mg twice daily dose of trospium chloride was chosen because this achieves the C max expected in severe renal impairment. Trospium chloride was not associated with an increase in individual corrected (QTcI) or Fridericia corrected (QTcF) QT interval at any time during steady state measurement, while moxifloxacin was associated with a 6.4 msec increase in QTcF.

In this study, asymptomatic, non-specific T wave inversions were observed more often in subjects receiving trospium chloride than in subjects receiving moxifloxacin or placebo following five days of treatment. This finding was not observed during routine safety monitoring in 2 other placebo-controlled clinical trials in 591 trospium chloride treated overactive bladder patients [ see Clinical Studies ( 14 ) ]. The clinical significance of T wave inversion in this study is unknown.

Trospium chloride is associated with an increase in heart rate that correlates with increasing plasma concentrations. In the study described above, trospium chloride demonstrated a mean increase in heart rate compared to placebo of 9.1 bpm for the 20 mg dose and of 18 bpm for the 100 mg dose. In the two U.S. placebo-controlled trials in patients with overactive bladder, the mean increase in heart rate compared to placebo in Study 1 was observed to be 3 bpm and in Study 2 was 4 bpm.

12.3Pharmacokinetics Absorption: After oral administration, less than 10% of the dose is absorbed. Mean absolute bioavailability of a 20 mg dose is 9.6% (range: 4 to 16.1%). Peak plasma concentrations (C max ) occur between 5 to 6 hours post-dose.

Mean C max increases greater than dose-proportionally; a 3-fold and 4-fold increase in C max was observed for dose increases from 20 mg to 40 mg and from 20 mg to 60 mg, respectively. AUC exhibits dose linearity for single doses up to 60 mg. Trospium chloride exhibits diurnal variability in exposure with a decrease in C max and AUC of up to 59% and 33%, respectively, for evening relative to morning doses.

Effect of Food: Administration with a high (50%) fat-content meal resulted in reduced absorption, with AUC and C max values 70 to 80% lower than those obtained when trospium chloride was administered while fasting. Therefore, it is recommended that trospium chloride should be taken at least one hour prior to meals or on an empty stomach [ see Dosage and Administration ( 2 ) ]. A summary of mean (± standard deviation) pharmacokinetic parameters for a single 20 mg dose of trospium chloride tablets is provided in Table 2.

Table 2. Mean (± SD) Pharmacokinetic Parameter Estimates for a Single Dose of Trospium Chloride Tablets in Healthy Volunteers C max (ng/mL) AUC 0-∞ (ng/mL•hr) T max (hr) t ½ (hr) 3.5 ± 4.0 36.4 ± 21.8 5.3 ± 1.2 18.3 ±

3.2The mean plasma concentration-time (+ SD) profile for trospi… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 62 words ▾

12.1Mechanism of Action Trospium chloride is a muscarinic antagonist. Trospium chloride antagonizes the effect of acetylcholine on muscarinic receptors in cholinergically innervated organs including the bladder. Its parasympatholytic action reduces the tonus of smooth muscle in the bladder.

Receptor assays showed that trospium chloride has negligible affinity for nicotinic receptors as compared to muscarinic receptors at concentrations obtained from therapeutic doses.

📦 How Supplied / Storage and Handling 86 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Trospium Chloride Tablets USP, 20 mg intended for oral administration are round, white to off-white, film coated tablets. Imprinted "HP" with black ink on one side and "530" on the reverse side. They are supplied as follows: Bottle of 60 tablets, NDC 0904-7059-52 Store at 20 o to 25 o C (68 o to 77 o F) [see USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Keep container tightly closed

📋 Description 129 words ▾

11 DESCRIPTION Trospium chloride is a quaternary ammonium compound with the chemical name of Spiro [8-azoniabicyclo[3.2.1]octane-8,1'-pyrrolidinium], 3-[(hydroxydiphenylacetyl)oxy]-, chloride, (1α, 3β, 5α). The empirical formula of trospium chloride is C 25 H 30 ClNO 3 and its molecular weight is 427.96. The structural formula of trospium chloride is represented below: Trospium chloride is a white or almost white, crystalline powder.

The compound is very soluble in water. Each trospium chloride tablet intended for oral administration contains 20 mg of trospium chloride, a muscarinic antagonist, for oral administration. Each trospium chloride tablet also contains the following inactive ingredients: black iron oxide, confectioners' sugar, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, shellac, silicon dioxide, talc and titanium dioxide.

Product meets USP Dissolution Test 2. structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION "See FDA-approved Patient Labeling (Patient Information)"

17.1Angioedema Patients should be informed that trospium chloride, the active ingredient in trospium chloride tablets, may produce angioedema which could result in life-threatening airway obstruction. Patients should be advised to promptly discontinue trospium chloride tablets and seek immediate medical attention if they experience edema of the tongue, edema of the laryngopharynx, or difficulty breathing.

17.2When Not to Use Prior to treatment, patients should fully understand the risks and benefits of trospium chloride. In particular, patients should be informed not to take trospium chloride tablets if they: have urinary retention; gastric retention; uncontrolled narrow-angle glaucoma; are allergic to any component of trospium chloride tablets.

17.3Administration Patients should be instructed regarding the recommended dosing and administration of trospium chloride tablets: Take one trospium chloride tablet twice daily with water. Take trospium chloride tablets on an empty stomach or at least 1 hour before a meal.

17.4Adverse Reactions Patients should be informed that the most common side effects with trospium chloride tablets are dry mouth and constipation and that other less common side effects include trouble emptying the bladder, blurred vision, and heat prostration. Because anticholinergics, such as trospium chloride, may produce dizziness or blurred vision, patients should be advised to exercise caution in decisions to engage in potentially dangerous activities until the drug's effects have been determined. Patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents. + SANCUTURA XR ® is a registered trademark by Allergan Inc. for Trospium Chloride Extended-Release Capsules, 60 mg. ++ Glucophage ® is a registered trade mark by Bristol Meyers Squibb for Metformin Hydrochloride Tablets.

Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) Distributed By: MAJOR® PHARMACEUTICALS 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 Revised: 06/2020 Patient Information Leaflet Trospium (TROSE-pee-um) Chloride Tablets, USP Read the Patient Information that comes with trospium chloride tablets before you start taking it and each time you get a refill. There may be new information.

This leaflet does not take the place of talking with your doctor about your medical condition or your treatment. What is trospium chloride tablets? Trospium chloride tablets are a prescription medicine used to treat adults with overactive bladder who have the following symptoms: a strong need to urinate right away; leaking or wetting accidents due to a strong need to urinate right away; a need to urinate often.

Who should not take trospium chloride tablets? Do not take trospium chloride tablets if you: have trouble emptying your bladder; have delayed or slow emptying of your stomach; have an eye problem called "uncontrolled narrow-angle glaucoma"; are allergic to trospium chloride tablets or any of its ingredients. See the end of this leaflet for a complete list of ingredients.

Trospium chloride tablets has not been studied in children under the age of 18 years. What should I tell my doctor before starting trospium chloride tablets? Tell your doctor about all of your medical conditions including if you: have any stomach or intestinal problems or problems with constipation; have trouble emptying your bladder or have a weak urine stream; have an eye problem called narrow-angle glaucoma; have kidney problems; have liver problems; are pregnant or planning to become pregnant.

It is not known if trospium chloride can harm your unborn baby. are breastfeeding. It is not known if trospium chloride passes into breast milk and if it can harm your baby. You should talk to your doctor about the best way to feed your baby if you are taking trospium chloride tablets.

Tell your doctor about all the… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 70 words ▾

8.3Nursing Mothers Trospium chloride (2 mg/kg orally and 50 mcg/kg intravenously) was excreted, to a limited extent (less than 1%), into the milk of lactating rats (primarily as parent compound). It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, trospium chloride should be used during lactation only if the potential benefit justifies the potential risk to the newborn.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES Trospium chloride was evaluated for the treatment of patients with overactive bladder who had symptoms of urinary frequency, urgency, and urge incontinence in two U.S. 12-week, placebo-controlled studies and one 9-month open label extension. Study 1 was a randomized, double-blind, placebo-controlled, parallel-group study in 523 patients.

A total of 262 patients received trospium chloride tablets 20 mg twice daily and 261 patients received placebo. The majority of patients were Caucasian (85%) and female (74%) with a mean age of 61 years (range: 21 to 90 years). Entry criteria required that patients have urge or mixed incontinence (with a predominance of urge), urge incontinence episodes of at least 7 per week, and greater than 70 micturitions per week.

The patient's medical history and urinary diary during the treatment-free baseline confirmed the diagnosis. Reductions in urinary frequency, urge incontinence episodes and urinary void volume for placebo and trospium chloride treatment groups are summarized in Table 3 and Figures 2 and 3. Table 3.

Mean (SE) change from baseline to end of treatment (Week 12 or last observation carried forward) for urinary frequency, urge incontinence episodes, and void volume in Study 1 Efficacy endpoint Placebo N=256 Trospium Chloride N=253 P-value Urinary frequency/24 hours a,* Mean baseline Mean change from baseline 12.9 -1.3 (0.2) 12.7 -2.4 (0.2) <0.001 Urge incontinence episodes/week b,* Mean baseline Mean change from baseline 30.1 -13.9 (1.2) 27.3 -15.4 (1.1) 0.012 Urinary void volume/toilet void (mL) a,c Mean baseline Mean change from baseline 156.6 7.7 (3.1) 155.1 32.1 (3.1) <0.001 a Treatment differences assessed by analysis of variance for ITT:LOCF data set. b Treatment differences assessed by ranked analysis of variance for ITT:LOCF data set. c Placebo N=253, Trospium Chloride N=248. * Denotes co-primary endpoint ITT=intent-to-treat, LOCF=last observation carried forward.

Figure 2 – Mean Change from Baseline in Urinary Frequency/24 Hours, by Visit: Study 1 Figure 3 – Mean Change from Baseline in Urge Incontinence/Week, by Visit: Study 1 Study 2 was nearly identical in design to Study 1. A total of 329 patients received trospium chloride tablets 20 mg twice daily and 329 patients received placebo. The majority of patients were Caucasian (88%) and female (82%) with a mean age of 61 years (range: 19 to 94 years).

Entry criteria were identical to Study 1. Reductions in urinary frequency, urge incontinence episodes, and urinary void volume for placebo and trospium chloride treatment groups are summarized in Table 4 and Figures 4 and 5. Table 4.

Mean (SE) change from baseline to end of treatment (Week 12 or last observation carried forward) for urinary frequency, urge incontinence episodes, and void volume in Study 2 Efficacy endpoint Placebo N=325 Trospium Chloride N=323 P-value Urinary frequency/24 hours a,* Mean baseline Mean change from baseline 13.2 -1.8 (0.2) 12.9 -2.7 (0.2) <0.001 Urge incontinence episodes/week b,* Mean baseline Mean change from baseline 27.3 -12.1 (1.0) 26.9 -16.1 (1.0) <0.001 Urinary void volume/toilet void (mL) a,c Mean baseline Mean change from baseline 154.6 9.4 (2.8) 154.8 35.6 (2.8) <0.001 a Treatment differences assessed by analysis of variance for ITT:LOCF data set. b Treatment differences assessed by ranked analysis of variance for ITT:LOCF data set. c Placebo N=320, Trospium Chloride N=319. * Denotes co-primary endpoint ITT=intent-to-treat, LOCF=last observation carried forward.

Figure 4 – Mean Change from Baseline in Urinary Frequency/24 Hours, by Visit: Study 2 Figure 5 – Mean Change from Baseline in Urge Incontinence/Week, by Visit: Study 2 figure 2 figure 3 figure 4 figure 5

🧪 Nonclinical Toxicology 132 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis: Carcinogenicity studies with trospium chloride were conducted in mice and rats for 78 weeks and 104 weeks, respectively, at maximally tolerated doses. No evidence of a carcinogenic effect was found in either mice or rats administered up to 200 mg/kg/day, approximately 9 times the expected clinical exposure levels at the maximum recommended human dose (MRHD) of 40 mg. Mutagenesis: Trospium chloride was not mutagenic nor genotoxic in tests in vitro in bacteria (Ames test) and mammalian cells (L5178Y mouse lymphoma and CHO cells) or in vivo in the rat micronucleus test.

Impairment of Fertility: No evidence of impaired fertility was observed in rats administered doses up to 200 mg/kg/day (about 16 times the expected clinical exposure at the MRHD, based on AUC).

📄 Recent Major Changes 14 words ▾

RECENT MAJOR CHANGES Warnings and Precautions, Central Nervous System Effects ( 5.5 ) 07/2012

📄 Package Label / Principal Display Panel 17 words ▾

PRINCIPAL DISPLAY PANEL - 20mg NDC 71610-812 - Trospium Chloride, USP 20mg Tablets - 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 Trospium Chloride — the program that covers self-administered drugs. 9 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 Trospium Chloride. 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
$7.67M
Claims incl. refills
162.7K
Beneficiaries
109.3K
Spend / beneficiary
$70.19
Spend / claim
$47.14
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 Aphena Pharma Solutions - Tennessee, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Aphena Pharma Solutions - Tennessee, 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.
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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.