HomeNDC LookupIngredientsBethanechol Chloride › 65162-0573-10
Bethanechol Chloride 25 mg Tablet, 100-count — NDC 65162-0573-10 package photo

Bethanechol Chloride 25 mg Tablet, 100-count

by Amneal Pharmaceuticals LLC · 100 TABLET in 1 BOTTLE (65162-573-10)
NDC 65162-0573-10
🏷️ FDA NDC (as labeled) 65162-573-10 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.1824 NADAC Per package$18.24 / 100 tablets Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.7355/unit · Part D plans $0.3761/unit — full pricing hub ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 65162-573-10
Product NDC 65162-573
11-digit billing NDC 65162057310
NCPDP billing unit EA — each (per item)
UNII H4QBZ2LO84
UPC 0365162573107, 0365162574104, 0365162572100, 0365162571103
Application # ANDA040855
SPL Set ID 45285692-de51-413e-8a51-7fb792eccc81
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 2007-11-21
Route ORAL
Dosage form TABLET
Substance BETHANECHOL CHLORIDE
GPI-14 54300010100330
GPI class Bethanechol Chloride
GCN Seq No 004741
GCN 18352
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 25 MG TABLET
FDB brand name Bethanechol Chloride
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AA · RLD · RS
Why two NDCs? The FDA registers this code as 65162-573-10 — 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 → 65162-0573-10. 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.

🏭 Manufacturer & labeler

LabelerAmneal Pharmaceuticals LLC
Application holderAMNEAL PHARMACEUTICAL
FDA applicationANDA040855 (ANDA)
Labeler code65162
First marketedNov 2007
Product typeHuman Prescription Drug
Portfolio472 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.

🩺 Clinical

Label name BETHANECHOL 25 MG TABLET Ingredient Bethanechol Chloride
📖 What it is MedlinePlus · NLM

Bethanechol is used to relieve difficulties in urinating caused by surgery, drugs, or other factors. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Bethanechol helps your bladder muscle contract so you can urinate when it's not doing that on its own. This can happen after surgery, after giving birth, or when nerve problems wea...
  • What exactly is bethanechol supposed to do for me?
  • Yes — it really matters. Try to take bethanechol when your stomach is empty. If you take it shortly after eating, you're much more likely to feel nauseated or even vomit. An empty...
  • Does it matter if I take it with food or on an empty stomach?
📖 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.

💊 What it looks like

Color white / yellow
ShapeRound
ImprintAN;574
Size11 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.

7 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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.

💲 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 $0.182 $18.24 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.7355 $73.55 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.3761 $37.61 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.315 $0.182
▼ Down 34% over the last 24 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Bethanechol Chloride 25 mg 00832-0512-00 Upsher-Smith 100 tablets $0.182 AA Availability likely
Bethanechol Chloride 25 mg 23155-0936-01 Heritage 100 tablets $0.182 AA Availability likely
Bethanechol Chloride 25 mg 53746-0573-01 Amneal 100 tablets $0.182 AA Availability likely
Bethanechol Chloride 25 mg 60687-0700-01 American 100 tablets $0.182 AA Availability likely
Bethanechol Chloride 25 mg 62135-0757-12 Chartwell 120 tablets $0.182 AA Availability likely
Bethanechol Chloride 25 mgthis 65162-0573-10 Amneal 100 tablets $0.182 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
Nov 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 65162-0573-10, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
200
Units reimbursed last 4 qtrs
9.3K
Gross reimbursed last 4 qtrs
$6.8K
Avg / prescription
$34.08
Avg / unit
$0.7355
Latest quarter Q4 2025
47Rx
Medicaid pays / ea
$0.7355
gross reimbursed
vs
NADAC / ea
$0.1824
acquisition cost
=
Spread
+$0.5531
+303% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
94% MCO
Fee-for-service · 12 Rx Managed care · 188 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 4,503 units · 34.7 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 1,911 units · 25.7 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 102 units · 0.9 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 2,751 units · 9.0 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.934.7
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Pennsylvania 34.7 /100k
2 Arizona 25.7 /100k
3 Texas 9.0 /100k
4 North Carolina 0.9 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
Drug total (last 4 qtrs): 200 Rx · 9,267 units · $6,816 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
65162-0573-10 You're viewing this 100 TABLET in 1 BOTTLE (65162-573-10) $0.1824 / ea $18.24 2007-11-21 Active
65162-0573-11 1000 TABLET in 1 BOTTLE (65162-573-11) 2007-11-21 Active
65162-0573-50 500 TABLET in 1 BOTTLE (65162-573-50) 2007-11-21 Active

You're viewing the smallest of 3 pack sizes for this product.

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 65162-0573-10?
NDC 65162-0573-10 is a 100-count package — 100 tablet in 1 bottle.
What is the difference between NDC 65162-0573-10 and NDC 65162-0573-50?
Both are Bethanechol Chloride 25 mg Tablet — the drug itself is identical. NDC 65162-0573-10 is the 100-count package, while NDC 65162-0573-50 is the 500 tablets package.
What NDC number is used to bill for this package of Bethanechol Chloride 25 mg Tablet?
Bill NDC 65162-0573-10 — the 11-digit billing format is 65162057310. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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 30 words

INDICATIONS AND USAGE Bethanechol 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.

⏱️ 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 143 words

ADVERSE REACTIONS 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 To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🆘 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 ~1 min read

HOW SUPPLIED Bethanechol Chloride Tablets, USP, 5 mg are supplied as white, round, flat-faced, bevelled tablets debossed with ‘AN’ above bisect and ‘571’ below bisect on one side and plain on the other side. They are available as follows: Bottle of 100: NDC 65162-571-10 Bottle of 500: NDC 65162-571-50 Bottle of 1000: NDC 65162-571-11 Bethanechol Chloride Tablets, USP, 10 mg are supplied as white, round, flat-faced, bevelled tablets debossed with ‘AN’ above bisect and ‘572’ below bisect on one side and plain on the other side.

They are available as follows: Bottle of 100: NDC 65162-572-10 Bottle of 500: NDC 65162-572-50 Bottle of 1000: NDC 65162-572-11 Bethanechol Chloride Tablets, USP, 25 mg are supplied as yellow, round, flat-faced, bevelled tablets debossed with ‘AN’ above bisect and ‘573’ below bisect on one side and plain on the other side. They are available as follows: Bottle of 100: NDC 65162-573-10 Bottle of 500: NDC 65162-573-50 Bottle of 1000: NDC 65162-573-11 Bethanechol Chloride Tablets, USP, 50 mg are supplied as yellow, round, flat-faced, bevelled tablets debossed with ‘AN’ above bisect and ‘574’ below bisect on one side and plain on the other side.

They are available as follows: Bottle of 100: NDC 65162-574-10 Bottle of 500: NDC 65162-574-50 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. This container is not intended for household use. 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. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 05-2018-03

📋 Description 129 words

DESCRIPTION Bethanechol chloride, 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 molecular formula is C 7 H 17 CIN 2 0 2 and its structural formula is: It is a white, hygroscopic crystalline powder having a slight amine-like odor, freely soluble in water, and has a molecular weight of 196.68.

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. The 25 mg and 50 mg tablets also contain D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Aluminum Lake.

38055a93-figure-01

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