Quick answers
- What is Trospium chloride used for?
- The FDA-approved label (Trospium Chloride, Major Pharmaceuticals, September 3, 2026) says: “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.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Trospium chloride have a boxed warning?
- No. None of the 24 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Trospium chloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Trospium chloride been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started November 1, 2023 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Trospium chloride?
- 19 companies list prescription products of Trospium chloride in the FDA NDC Directory, including Bryant Ranch Prepack, Padagis US LLC and Major Pharmaceuticals.
What Trospium chloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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.
— FDA label: Trospium Chloride, Major Pharmaceuticals, effective September 3, 2026. Read the full label on DailyMed →
The FDA has 24 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 24 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Capsule, extended release · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 28 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| trospium chloride 20 mg tablet | Generic | $0.2068 per tablet |
| trospium chloride 20 mg tablet, film coated | Generic | $0.2068 per tablet |
| trospium chloride 60 mg capsule, extended release | Generic | $1.61 per capsule |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack7 products
- Padagis US LLC2 products
- Major Pharmaceuticals2 products
- Remedyrepack Inc.2 products
- Zameer Pharmaceuticals LLC1 product
- Chartwell RX, LLC1 product
- Cipla USA Inc.1 product
- Actavis Pharma, Inc.1 product
- PD-Rx Pharmaceuticals, Inc.1 product
- Golden State Medical Supply, Inc.1 product
- Granules Pharmaceuticals Inc.1 product
- Aphena Pharma Solutions - Tennessee, LLC1 product
- Exelan Pharmaceuticals Inc.1 product
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1 product
- BluePoint Laboratories1 product
- Proficient Rx LP1 product
- Slate Run Pharmaceuticals, LLC1 product
- Macleods Pharmaceuticals Limited1 product
- Glenmark Pharmaceuticals Inc., USA1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (10)
- ANDA091575Glenmark Pharms Ltd · August 13, 2010
- ANDA091573Padagis Us · November 17, 2010
- ANDA091289Actavis Labs Fl Inc · October 12, 2012
- ANDA201291Padagis Us · May 24, 2013
- ANDA091688Invagen Pharms · August 23, 2016
- ANDA204945Heritage Pharms Inc · August 30, 2016
- ANDA213185Granules · April 23, 2020
- ANDA214760Utopic Pharms · April 30, 2021
- ANDA215781Chartwell Rx · February 16, 2022
- ANDA206472Macleods Pharms · June 18, 2024
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
November 1, 2023 · Class II · Ongoing · D-0139-2024
Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules
Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only, Manufactured By: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun-248 197 Uttarakhand, — Padagis US LLC
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 857560, 857564 |
|---|---|
| SPL set ID of the quoted label | 7a2fea88-266d-4fc0-a476-66dc6effcff7 |
| FDA labels (SPL) | 24 |
| FDA applications | 10 ANDA |
| Active ingredients (FDA) | TROSPIUM |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Trospium Chloride, Major Pharmaceuticals, effective September 3, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →