Bethanechol Chloride

Sold as Urecholine. Every FDA application for this active ingredient: 1 branded and 53 generic.

As of Nov 15, 2026, FDA lists 54 applications for Bethanechol Chloride (sold as Urecholine), first approved Oct 12, 1948, with 0 new uses approved and 0 published complete response letters.

First approved: Oct 12, 1948
Applications: 54
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $10.1M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Bethanechol Chloride	Part D	$10.1M	-8%	44,708

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

BETHANECHOL 10 MG TABLET: $0.148 per unitGeneric · -23% in a year
BETHANECHOL 25 MG TABLET: $0.179 per unitGeneric · -23% in a year
BETHANECHOL 5 MG TABLET: $0.121 per unitGeneric · -19% in a year
BETHANECHOL 50 MG TABLET: $0.264 per unitGeneric · -27% in a year

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
Stimulation With Bethanechol in Combination With Gemcitabine and Nab-paclitaxel in Pancreatic AdenocarcinomaPancreas Cancer · Susan E. Bates	Phase 2	Recruiting	Feb 15, 2022

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Oct 12, 1948	UrecholineNDA 6536	Teva Branded Pharm	31	Discontinued
Nov 11, 1974	Bethanechol ChlorideANDA 84408	Watson Labs	11	Discontinued
Nov 26, 1974	Bethanechol ChlorideANDA 84402	Watson Labs	3	Discontinued
Jan 14, 1975	Bethanechol ChlorideANDA 84441	Watson Labs	13	Discontinued
Jul 29, 1975	Bethanechol ChlorideANDA 84712	Lannett	1	Discontinued
Sep 24, 1975	MyotonacholANDA 84188	Glenwood	0	Discontinued
Dec 16, 1975	Bethanechol ChlorideANDA 84689	Ivax Sub Teva Pharms	0	Discontinued
Jun 16, 1976	Bethanechol ChlorideANDA 84702	Lannett	1	Discontinued
Jul 1, 1976	Bethanechol ChlorideANDA 84074	Lannett	0	Discontinued
Aug 26, 1977	Bethanechol ChlorideANDA 85839	Watson Labs	1	Discontinued
Aug 26, 1977	Bethanechol ChlorideANDA 85842	Watson Labs	1	Discontinued
Mar 22, 1978	DuvoidANDA 85882	Chartwell Rx	5	Marketed
Mar 22, 1978	DuvoidANDA 86262	Chartwell Rx	4	Marketed
Mar 22, 1978	DuvoidANDA 86263	Chartwell Rx	5	Marketed
Jul 16, 1981	Bethanechol ChlorideANDA 87444	Watson Labs	7	Discontinued
May 29, 1984	UrecholineANDA 88441	Odyssey Pharms	16	Discontinued
May 29, 1984	UrecholineANDA 88440	Odyssey Pharms	14	Discontinued
Dec 19, 1985	UrecholineANDA 89095	Odyssey Pharms	12	Discontinued
Dec 19, 1985	UrecholineANDA 89096	Odyssey Pharms	13	Discontinued
Sep 16, 1994	Bethanechol ChlorideANDA 84353	Sandoz	2	Discontinued
Sep 16, 1994	Bethanechol ChlorideANDA 84378	Sandoz	2	Discontinued
Sep 16, 1994	Bethanechol ChlorideANDA 84379	Sandoz	1	Discontinued
Sep 16, 1994	Bethanechol ChlorideANDA 84383	Sandoz	1	Discontinued
Sep 16, 1994	Bethanechol ChlorideANDA 84384	Sandoz	2	Discontinued
Sep 29, 2003	Bethanechol ChlorideANDA 40518	Wockhardt	0	Discontinued
Sep 29, 2003	Bethanechol ChlorideANDA 40532	Wockhardt	0	Discontinued
Sep 29, 2003	Bethanechol ChlorideANDA 40533	Wockhardt	0	Discontinued
Sep 29, 2003	Bethanechol ChlorideANDA 40534	Wockhardt	0	Discontinued
Jul 27, 2004	Bethanechol ChlorideANDA 40492	Able	0	Discontinued
Jul 27, 2004	Bethanechol ChlorideANDA 40483	Able	0	Discontinued
Jul 27, 2004	Bethanechol ChlorideANDA 40485	Able	0	Discontinued
Jul 27, 2004	Bethanechol ChlorideANDA 40509	Able	0	Discontinued
Oct 28, 2004	Bethanechol ChlorideANDA 40552	Actavis Elizabeth	0	Discontinued
Oct 28, 2004	Bethanechol ChlorideANDA 40553	Actavis Elizabeth	0	Discontinued
Oct 28, 2004	Bethanechol ChlorideANDA 40554	Actavis Elizabeth	0	Discontinued
Oct 28, 2004	Bethanechol ChlorideANDA 40551	Actavis Elizabeth	0	Discontinued
Jun 1, 2005	Bethanechol ChlorideANDA 40633	Upsher Smith Labs	0	Marketed
Jun 1, 2005	Bethanechol ChlorideANDA 40634	Upsher Smith Labs	0	Marketed
Jun 1, 2005	Bethanechol ChlorideANDA 40635	Upsher Smith Labs	0	Marketed
Jun 1, 2005	Bethanechol ChlorideANDA 40636	Upsher Smith Labs	0	Marketed
Nov 1, 2006	Bethanechol ChlorideANDA 40721	Impax Labs	0	Discontinued
Oct 26, 2007	Bethanechol ChlorideANDA 40728	Chartwell Rx	1	Marketed
Nov 21, 2007	Bethanechol ChlorideANDA 40855	Amneal Pharm	0	Marketed
Mar 27, 2008	Bethanechol ChlorideANDA 40677	Lannett Co Inc	0	Discontinued
Apr 22, 2009	Bethanechol ChlorideANDA 40897	Sun Pharm Inds Inc	0	Discontinued
May 4, 2010	Bethanechol ChlorideANDA 91256	Heritage Pharma	0	Marketed
—	Bethanechol ChlorideANDA 88288	Ascot	0	Discontinued
—	Bethanechol ChlorideANDA 88289	Ascot	0	Discontinued
—	Bethanechol ChlorideANDA 85228	Watson Labs	0	Discontinued
—	Bethanechol ChlorideANDA 85229	Watson Labs	0	Discontinued
—	Bethanechol ChlorideANDA 85230	Watson Labs	0	Discontinued
—	Bethanechol ChlorideANDA 85841	Watson Labs	2	Discontinued
—	Bethanechol ChlorideANDA 87397	Watson Labs	0	Discontinued
—	Bethanechol ChlorideANDA 89815	Quad Pharms	0	Discontinued

Show all 54

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA