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Bethanechol Chloride 10 mg Tablet, 120-count — NDC 62135-0756-12 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Bethanechol Chloride 10 mg Tablet, 120-count — NDC 62135-756-12 (Billing 62135-0756-12)

by Chartwell RX, LLC · 120 TABLET in 1 BOTTLE

This is a package of 120 tablets of Bethanechol Chloride 10 mg Tablet from Chartwell RX, LLC, marketed since Oct 2007 and currently FDA-listed; retail pharmacies pay about $0.1499 per tablet (NADAC). It is this product's only package size.

NDC 62135-0756-12
🏷️ FDA NDC (as labeled) 62135-756-12 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 62135-756-12
Product NDC 62135-756
11-digit billing NDC 62135075612
NCPDP billing unit EA — each (per item)
RxCUI 857321, 857328, 857336, 857340
UNII H4QBZ2LO84
UPC 0362135756123, 0362135757120, 0362135755904, 0362135758127
Application # ANDA040728
SPL Set ID 89267333-ba8b-455b-a8dc-515a888463c2
Established class (EPC) Cholinergic Muscarinic Agonist
Mechanism of action Cholinergic Muscarinic Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2007-10-26
Route ORAL
Dosage form TABLET
Substance BETHANECHOL CHLORIDE
TE code (Orange Book) AA · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 54300010100320
GCN Seq No 004740
GCN 18351
HICL code 001978
Ingredient (HICL) Bethanechol Chloride
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J1
Therapeutic class — intermediate (HIC2) Cholinergics
HIC3 code J1A
Therapeutic class — specific (HIC3) Parasympathetic Agents
AHFS code 12:04.00.00
AHFS class Parasympathomimetic (Cholinergic Agents)
FDB label name BETHANECHOL 10 MG TABLET
FDB brand name Bethanechol Chloride
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 004740
  • GCN: 18351
  • GPI-14 (Medi-Span): 54300010100320
  • HICL (First Databank): 001978
  • AHFS class code: 12:04.00.00
  • RxCUI (RxNorm): 857321
Why two NDCs? The FDA registers this code as 62135-756-12 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 62135-0756-12. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Cholinergic Muscarinic Agonist class.

Pharmacologic class Cholinergic Muscarinic Agonist
Drug family (ATC) Choline esters
How it works Cholinergic Muscarinic Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name BETHANECHOL 10 MG TABLET Ingredient Bethanechol Chloride
📗 Our plain-language guide HelloPharmacist
  • It helps you empty your bladder when it isn’t contracting well. It is used after surgery or childbirth when nothing is blocking urine flow, and for a weak bladder caused by a nerve...
  • Take it by mouth, usually three or four times a day, as your prescriber directs. Try to take it on an empty stomach, because taking it soon after a meal can cause nausea and vomiti...
  • Sometimes you’ll notice an effect within 30 minutes. More often it takes 60 to 90 minutes to work best, and the effect lasts about an hour.
  • Side effects are uncommon with tablets, but you might get stomach cramps, nausea, diarrhea, extra saliva, flushing, sweating or headache. They are more likely as the dose goes up....
📖 Read our full Bethanechol guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.150 $17.99 / 120 tablets
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.1993 $23.92 / 120 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $0.173 $0.150
▼ Down 13% over the last 10 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
62135-0756-12 You're viewing this Main listing 120 TABLET in 1 BOTTLE 2024-01-17 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Bethanechol Chloride 10 mg 00832-0511-00 Upsher-Smith 100 tablets $0.150 AA Availability likely —
Bethanechol Chloride 10 mg 23155-0935-01 Heritage 100 tablets $0.150 AA Availability likely —
Bethanechol Chloride 10 mg 53746-0572-01 Amneal 100 tablets $0.150 AA Availability likely —
Bethanechol Chloride 10 mg 60687-0689-01 American 100 tablets $0.150 AA Availability likely —
Bethanechol Chloride 10 mgthis 62135-0756-12 Chartwell 120 tablets $0.150 AA Availability likely —
Bethanechol Chloride 10 mg 65162-0572-10 Amneal 100 tablets $0.150 AA Availability likely —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2007
On the market since
Oct 2007
📍
2026
Currently FDA-listed
19 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerChartwell RX, LLC
Application holderCHARTWELL RX SCIENCES LLC
FDA applicationANDA040728 (ANDA)
Labeler code62135
First marketedOct 2007
Product typeHuman Prescription Drug
Portfolio521 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 31 words ▾

INDICATIONS AND USAGE Bethanechol Chloride Tablets, USP are indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.

⏱️ Dosage and Administration 133 words ▾

DOSAGE AND ADMINISTRATION Dosage must be individualized, depending on the type and severity of the condition to be treated. Preferably give the drug when the stomach is empty. If taken soon after eating, nausea and vomiting may occur.

The usual adult oral dose ranges from 10 to 50 mg three or four times a day. The minimum effective dose is determined by giving 5 to 10 mg initially and repeating the same amount at hourly intervals until satisfactory response occurs, or until a maximum of 50 mg has been given. The effects of the drug sometimes appear within 30 minutes and are usually maximal within 60 to 90 minutes.

The drug effects persist for about one hour. If necessary, the effects of the drug can be abolished promptly by atropine (see OVERDOSAGE ).

⛔ Contraindications 103 words ▾

CONTRAINDICATIONS Hypersensitivity to bethanechol chloride, hyperthyroidism, peptic ulcer, latent or active bronchial asthma, pronounced bradycardia or hypotension, vasomotor instability, coronary artery disease, epilepsy and parkinsonism. Bethanechol chloride should not be employed when the strength or integrity of the gastrointestinal or bladder wall is in question, or in the presence of mechanical obstruction; when increased muscular activity of the gastrointestinal tract or urinary bladder might prove harmful, as following recent urinary bladder surgery, gastrointestinal resection and anastomosis, or when there is possible gastrointestinal obstruction; in bladder neck obstruction, spastic gastrointestinal disturbances, acute inflammatory lesions of the gastrointestinal tract, or peritonitis; or in marked vagotonia.

🤒 Adverse Reactions 126 words ▾

ADVERSE REACTION Adverse reactions are rare following oral administration of bethanechol chloride, but are more common following subcutaneous injection. Adverse reactions are more likely to occur when dosage is increased. The following adverse reactions have been observed: Body as a Whole: malaise Digestive: abdominal cramps or discomfort, colicky pain, nausea and belching, diarrhea, borborygmi, salivation Renal: urinary urgency Nervous System: headache Cardiovascular: a fall in blood pressure with reflex tachycardia, vasomotor response Skin: flushing producing a feeling of warmth, sensation of heat about the face, sweating Respiratory: bronchial constriction, asthmatic attacks Special Senses: lacrimation, miosis Causal Relationship Unknown: The following adverse reactions have been reported, and a causal relationship to therapy with bethanechol chloride has not been established: Body as a Whole: malaise Nervous System: seizures

🆘 Overdosage 118 words ▾

OVERDOSAGE Early signs of overdosage are abdominal discomfort, salivation, flushing of the skin (“hot feeling”), sweating, nausea, and vomiting. Atropine sulfate is a specific antidote. The recommended dose for adults is 0.6 mg.

Repeat doses can be given every two hours, according to clinical response. The recommended dosage in infants and children up to 12 years of age is 0.01 mg/kg (to a maximum single dose of 0.4 mg) repeated every two hours as needed until the desired effect is obtained or adverse effects of atropine preclude further usage. Subcutaneous injection of atropine is preferred except in emergencies when the intravenous route may be employed.

The oral LD 50 of bethanechol chloride is 1510 mg/kg in the mouse.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY Bethanechol chloride acts principally by producing the effects of stimulation of the parasympathetic nervous system. It increases the tone of the detrusor urinae muscle, usually producing a contraction sufficiently strong to initiate micturition and empty the bladder. It stimulates gastric motility, increases gastric tone and often restores impaired rhythmic peristalsis.

Stimulation of the parasympathetic nervous system releases acetylcholine at the nerve endings. When spontaneous stimulation is reduced and therapeutic intervention is required, acetylcholine can be given, but it is rapidly hydrolyzed by cholinesterase and its effects are transient. Bethanechol chloride is not destroyed by cholinesterase and its effects are more prolonged than those of acetylcholine.

Effects on the GI and urinary tracts sometimes appear within 30 minutes after oral administration of bethanechol chloride, but more often 60 to 90 minutes are required to reach maximum effectiveness. Following oral administration, the usual duration of action of bethanechol chloride is one hour, although large doses (300 to 400 mg) have been reported to produce effects for up to six hours. Subcutaneous injection produces a more intense action on bladder muscle than does oral administration of the drug.

Because of the selective action of bethanechol chloride, nicotinic symptoms of cholinergic stimulation are usually absent or minimal when orally or subcutaneously administered in therapeutic doses, while muscarinic effects are prominent. Muscarinic effects usually occur within 5 to 15 minutes after subcutaneous injection, reach a maximum in 15 to 30 minutes, and disappear within two hours. Doses that stimulate micturition and defecation and increase peristalsis do not ordinarily stimulate ganglia or voluntary muscles.

Therapeutic test doses in normal human subjects have little effect on heart rate, blood pressure or peripheral circulation. Bethanechol chloride does not cross the blood-brain barrier because of its charged quaternary amine moiety. The metabolic rate and mode of excretion of the drug have not been elucidated.

A clinical study (Diokno, A.C.; Lapides, J.; Urol 10: 23-24, July 1977) was conducted on the relative effectiveness of oral and subcutaneous doses of bethanechol chloride on the stretch response of bladder muscle in patients with urinary retention. Results showed that 5 mg of the drug given subcutaneously stimulated a response that was more rapid in onset and of larger magnitude than an oral dose of 50 mg, 100 mg, or 200 mg. All the oral doses, however, had a longer duration of effect than the subcutaneous dose.

Although the 50 mg oral dose caused little change in intravesical pressure in this study, this dose has been found in other studies to be clinically effective in the rehabilitation of patients with decompensated bladders.

📦 How Supplied / Storage and Handling 201 words ▾

HOW SUPPLIED Bethanechol Chloride Tablets, USP is available as follows: 5 mg: White round, flat-faced, beveled edge tablet, debossed with “CE” above the score and “176” below the score on one side, and plain on the other side. Available in bottles of 90 (NDC 62135-755-90) 10 mg: White round, flat-faced, beveled edge tablet, debossed with “CE” above the score and “177” below the score on one side, and plain on the other side. Available in bottles of 120 (NDC 62135-756-12) 25 mg: Whiteround, flat-faced, beveled edge tablet, debossed with “CE” above the score and “178” below the score on one side, and plain on the other side.

Available in bottles of 120 (NDC 62135-757-12) 50 mg: White round, flat-faced, beveled edge tablet, debossed with “CE” above the score and “179” below the score on one side, and plain on the other side. Available in bottles of 120 (NDC 62135-758-12) Store at 20°C to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L71861 Rev. 01/2024

📋 Description 102 words ▾

DESCRIPTION Bethanechol chloride, USP, a cholinergic agent, is a synthetic ester which is structurally and pharmacologically related to acetylcholine. It is designated chemically as 2-[(aminocarbonyl)oxy]- N , N , N -trimethyl-1-propanaminium chloride. Its structural formula is: C 7 H 17 ClN 2 O 2 M.W.

196.68 It is a white, hygroscopic crystalline powder having a slight amine-like odor, freely soluble in water. Each tablet for oral administration contains 5 mg, 10 mg, 25 mg or 50 mg bethanechol chloride, USP. Tablets also contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. image description

⚠️ Precautions ~1 min read ▾

PRECAUTIONS General In urinary retention, if the sphincter fails to relax as bethanechol chloride contracts the bladder, urine may be forced up the ureter into the kidney pelvis. If there is bacteriuria, this may cause reflux infection. Information for Patients Bethanechol chloride should preferably be taken one hour before or two hours after meals to avoid nausea or vomiting.

Dizziness, lightheadedness or fainting may occur, especially when getting up from a lying or sitting position. Drug Interactions Special care is required if this drug is given to patients receiving ganglion blocking compounds because a critical fall in blood pressure may occur. Usually, severe abdominal symptoms appear before there is such a fall in the blood pressure.

Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate the effects upon fertility, mutagenic or carcinogenic potential of bethanechol chloride. Pregnancy Teratogenic Effects: Pregnancy Category C Animal reproduction studies have not been conducted with bethanechol chloride. It is also not known whether bethanechol chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Bethanechol chloride should be given to a pregnant woman only if clearly needed. Nursing Mothers It is not known whether this drug is secreted in human milk. Because many drugs are secreted in human milk and because of the potential for serious adverse reactions from bethanechol chloride in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

📄 Package Label / Principal Display Panel 72 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Bethanechol Chloride Tablets, USP 5 mg - NDC 62135-755-90 - 90s - Bottle - Label Bethanechol Chloride Tablets, USP 10 mg - NDC 62135-756-12 - 120s - Bottle - Label Bethanechol Chloride Tablets, USP 25 mg - NDC 62135-757-12 - 120s - Bottle - Label Bethanechol Chloride Tablets, USP 50 mg - NDC 62135-758-12 - 120s - Bottle - Label image description image description image description image description

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Bethanechol Chloride — the program that covers self-administered drugs. 6 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Bethanechol Chloride. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$2.4M
Claims incl. refills
46.7K
Beneficiaries
25K
Spend / beneficiary
$96.05
Spend / claim
$51.28
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Bethanechol Chloride — the ingredient across all brands.

Top reported reactions

Fall36
Death34
Urinary Tract Infection34
Fatigue33
Pneumonia31
Diarrhoea29
Dizziness27

Age at onset

Infant1
Child3
Adolescent3
Adult49
Elderly55

Reporter sex

546 reports
Male · 44%
Female · 56%

Serious outcomes

Hospitalization226
Death84
Life-threatening21
Disabling9
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 55 29
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
← 62135-0755-90 · Chartwell 62135-0757-12 · Chartwell →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.