Active ingredient
Bethanechol
22 finished FDA listings contain Bethanechol as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- BETHANECHOL, BETHANECHOL CHLORIDE
- Dosage forms
- Tablet
- Routes
- Oral
- Manufacturers / labelers
- 6
- Strengths listed
- 10 mg/1 · 25 mg/1 · 5 mg/1 · 50 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 19257
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 040633 | UPSHER SMITH LABS | 2005-06-01 | 1 |
| ANDA 040636 | UPSHER SMITH LABS | 2005-06-01 | 1 |
| ANDA 040634 | UPSHER SMITH LABS | 2005-06-01 | 1 |
| ANDA 040635 | UPSHER SMITH LABS | 2005-06-01 | 1 |
| ANDA 040728 | CHARTWELL RX | 2007-10-26 | 4 |
| ANDA 040855 | AMNEAL PHARM | 2007-11-21 | 10 |
| ANDA 091256 | HERITAGE PHARMA | 2010-05-04 | 4 |
Official labeling on DailyMed
- BETHANECHOL CHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] · version 5 · 2026-02-12
- BETHANECHOL CHLORIDE TABLET [HERITAGE PHARMA LABS INC. D/B/A AVET PHARMACEUTICALS LABS INC.] · version 2 · 2025-11-18
- BETHANECHOL CHLORIDE TABLET [AMERICAN HEALTH PACKAGING] · version 2 · 2024-12-04
- BETHANECHOL CHLORIDE TABLET [AMNEAL PHARMACEUTICALS LLC] · version 15 · 2024-10-25
- BETHANECHOL CHLORIDE TABLET [CHARTWELL RX, LLC] · version 1 · 2024-01-23
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.