Prescription medicine
Trospium First approved as Sanctura
Trospium (Sanctura) is a prescription medicine with an FDA approval on record since 2004. FDA's NDC Directory lists it from 19 generic labelers, and pharmacies paid $0.211 per trospium chloride 20 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the trospium FDA label on DailyMed (effective December 30, 2025, Glenmark Pharmaceuticals Inc., USA); the NDA 21595 record on Drugs@FDA; every trospium label on DailyMed.
Highlights of the record
FDA label of December 30, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageTrospium chloride tablets are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Forms and strengths
- 20 mg
- 60 mg
Film-coated tablet; extended-release capsule; tablet.
On the market
- Earliest approval on file
- May 28, 2004 Sanctura, Allergan; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 12 first August 13, 2010; 11 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 19 of which 19 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.211 per tablet Trospium chloride 20 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2023 0 Class I among all firms' recalls; latest November 1, 2023
- FAERS reports
- 2,273 through July 30, 2026
What is trospium used for?
From the label: indications and usageTrospium 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.
Conditions named in the indications of trospium's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Cholinergic Muscarinic Antagonist.
Source: FDA drug label (Trospium Chloride), Glenmark Pharmaceuticals Inc., USA, effective December 30, 2025 (SPL set d5c837a4-d1c6-4615-b7ad-27f3162a03aa), via openFDA; the full label on DailyMed
Is there a generic for trospium (Sanctura)?
The FDA approved the first generic trospium on August 13, 2010. 12 generic applications are approved; 11 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists trospium from 19 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2004 earliest approval on file
- 2010 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for trospium (Sanctura)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.211 per Trospium chloride 20 mg tablet, down 25% from $0.281 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Trospium chloride 20 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Trospium chloride 20 mg tablet | Generic | $0.211 per tablet | $6.34 | -25% |
| Trospium chloride ER 60 mg capsule | Generic | $1.64 per capsule | $49.29 | -11% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has trospium been recalled?
The FDA's Enforcement Report lists 1 recall naming trospium since 2023: 0 Class I (the most serious), 1 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| November 1, 2023 | Class II | Padagis US LLC | Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the trospium label say about other medicines?
The trospium label names 5 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Digoxin | drug interactions | Concomitant use with digoxin did not affect the pharmacokinetics of either drug. |
| Metformin | drug interactions | Concomitant use with metformin immediate release tablets reduced exposure and peak concentration of trospium. |
| Morphine | drug interactions | … interactions with other drugs that are eliminated by active tubular secretion (e.g., procainamide, pancuronium, morphine, vancomycin, and tenofovir). |
| Procainamide | drug interactions | … potential for pharmacokinetic interactions with other drugs that are eliminated by active tubular secretion (e.g., procainamide, pancuronium, morphine, vancomycin, and tenofovir). |
| Vancomycin | drug interactions | … with other drugs that are eliminated by active tubular secretion (e.g., procainamide, pancuronium, morphine, vancomycin, and tenofovir). |
Source: FDA drug label (Trospium Chloride), Glenmark Pharmaceuticals Inc., USA, effective December 30, 2025 (SPL set d5c837a4-d1c6-4615-b7ad-27f3162a03aa), via openFDA; the full label on DailyMed
What do FAERS reports show for trospium?
The FDA Adverse Event Reporting System holds 2,273 reports that list trospium among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 177 are coded as a death and 901 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as trospium?
7 other medicines are given the same way (oral) and in the same FDA class as trospium or labeled mainly for the same use (overactive bladder), the same class first. Overactive bladder lists all 9 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Oxybutynin | Overactive bladder | 41 labelers | $0.048 per tablet 5 mg tablet | No current entry |
| Solifenacin | Overactive bladder | 20 labelers | $0.162 per tablet 10 mg tablet | No current entry |
| Tolterodine | Overactive bladder | 14 labelers | $0.268 per capsule 2 mg capsule | No current entry |
| Darifenacin | Overactive bladder | 8 labelers | $0.432 per tablet 15 mg tablet | No current entry |
| Fesoterodine | Overactive bladder | 11 labelers | $0.794 per tablet 4 mg tablet | No current entry |
| Mirabegron | Overactive bladder | 8 labelers | $9.39 per tablet 50 mg tablet | No current entry |
| Vibegron | Overactive bladder | none listed | $16.46 per tablet 75 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does trospium compare with medicines for the same use?
4 side-by-side pages set trospium beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to trospium
- 7 medicines for the same use
- Other cholinergic muscarinic antagonists
- the pharmacologic class, with prices and generics
- Trospium side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other