Prescription medicine
Bethanechol First approved as Urecholine
Bethanechol (Urecholine) is a prescription medicine with an FDA approval on record since 1948. FDA's NDC Directory lists it from 6 generic labelers, and pharmacies paid $0.150 per bethanechol 10 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the bethanechol FDA label on DailyMed (effective January 29, 2026, Amneal Pharmaceuticals of New York LLC); the NDA 6536 record on Drugs@FDA; every bethanechol label on DailyMed.
Highlights of the record
FDA label of January 29, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageBethanechol chloride tablets are indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.
Forms and strengths
- 5 mg
- 10 mg
- 25 mg
- 50 mg
Tablet.
On the market
- Earliest approval on file
- October 12, 1948 Urecholine, Teva Branded Pharm; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 45 first November 11, 1974; 10 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 6 of which 6 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.150 per tablet Bethanechol 10 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2022 0 Class I among all firms' recalls; latest June 10, 2022
- FAERS reports
- 546 through July 30, 2026
What is bethanechol used for?
From the label: indications and usageBethanechol chloride tablets are indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.
FDA pharmacologic class: Cholinergic Muscarinic Agonist.
Source: FDA drug label (Bethanechol Chloride), Amneal Pharmaceuticals of New York LLC, effective January 29, 2026 (SPL set 16523451-cd3d-4c10-be06-d59a6f12ac68), via openFDA; the full label on DailyMed
Is there a generic for bethanechol (Urecholine)?
The FDA approved the first generic bethanechol on November 11, 1974. 45 generic applications are approved; 10 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 bethanechol from 6 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.
- 1948 earliest approval on file
- 1974 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 bethanechol (Urecholine)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.150 per Bethanechol 10 mg tablet, down 25% from $0.200 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.
- Bethanechol 10 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Bethanechol 10 mg tablet | Generic | $0.150 per tablet | $4.50 | -25% |
| Bethanechol 25 mg tablet | Generic | $0.188 per tablet | $5.63 | -19% |
| Bethanechol 5 mg tablet | Generic | $0.122 per tablet | $3.66 | -22% |
| Bethanechol 50 mg tablet | Generic | $0.270 per tablet | $8.11 | -31% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has bethanechol been recalled?
The FDA's Enforcement Report lists 1 recall naming bethanechol since 2022: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 10, 2022 | Class II | Wedgewood Village Pharmacy, LLC | Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the bethanechol label say about other medicines?
The bethanechol label names no other medicine on this site. The labels of 3 other medicines name bethanechol. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Source: FDA drug label (Bethanechol Chloride), Amneal Pharmaceuticals of New York LLC, effective January 29, 2026 (SPL set 16523451-cd3d-4c10-be06-d59a6f12ac68), via openFDA; the full label on DailyMed
What do FAERS reports show for bethanechol?
The FDA Adverse Event Reporting System holds 546 reports that list bethanechol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 84 are coded as a death and 226 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 next?
- Other cholinergic muscarinic agonists
- the pharmacologic class, with prices and generics
- Bethanechol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other