Active ingredient
Trospium
27 finished FDA listings contain Trospium as their only active ingredient; 3 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- TROSPIUM CHLORIDE
- Dosage forms
- Capsule, Extended Release, Tablet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 20
- Strengths listed
- 20 mg/1 · 60 mg/1
- Brand names in FDA listings
- Trospium Chloride Er
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 236778
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 091575 | GLENMARK PHARMS LTD | 2010-08-13 | 1 |
| ANDA 091573 | PADAGIS US | 2010-11-17 | 6 |
| ANDA 091289 | ACTAVIS LABS FL INC | 2012-10-12 | 2 |
| ANDA 201291 | PADAGIS US | 2013-05-24 | 4 |
| ANDA 091688 | INVAGEN PHARMS | 2016-08-23 | 2 |
| ANDA 204945 | HERITAGE PHARMS INC | 2016-08-30 | 6 |
| ANDA 213185 | GRANULES | 2020-04-23 | 3 |
| ANDA 214760 | UTOPIC PHARMS | 2021-04-30 | 1 |
| ANDA 215781 | CHARTWELL RX | 2022-02-16 | 1 |
| ANDA 206472 | MACLEODS PHARMS | 2024-06-18 | 1 |
Official labeling on DailyMed
- TROSPIUM CHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] · version 2 · 2026-09-07
- TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] · version 21 · 2026-08-17
- TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [SLATE RUN PHARMACEUTICALS, LLC] · version 14 · 2026-08-07
- TROSPIUM CHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.] · version 4 · 2026-04-27
- TROSPIUM CHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 102 · 2026-04-16
- TROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] · version 18 · 2025-12-31
- TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.] · version 5 · 2025-12-16
- TROSPIUM CHLORIDE TABLET, FILM COATED [CHARTWELL RX, LLC] · version 2 · 2025-12-12
- TROSPIUM CHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] · version 13 · 2025-11-17
- TROSPIUM CHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 100 · 2025-11-17
- TROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK] · version 100 · 2025-11-17
- TROSPIUM CHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] · version 6 · 2025-07-24
Showing the 12 most recent of 26 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.