Tolterodine tartrate 1 mg Tablet, Film Coated, 60-count
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Cholinergic Muscarinic Antagonist class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Tolterodine is used to treat overactive bladder (a bladder condition that causes sudden urges to urinate that may be hard to control). Tolterodine is in a class of medications called antimuscarinics. It works by relaxing the bladder muscles.
Read the full MedlinePlus article ↗- Tolterodine calms the bladder by blocking the nerve signals that cause it to squeeze too often or too urgently. Most people start noticing fewer urgent trips to the bathroom and le...
- What exactly does tolterodine do, and how quickly will I notice a difference?
- Dry mouth is the most common complaint with tolterodine, and it happens because the same receptors that calm your bladder also affect your saliva glands. Sipping water frequently,...
- The dry mouth is really bothersome — is there anything I can do about it?
Patient education
Supplement & herbal interactions
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💊 What it looks like
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🧪 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.
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UNII L11K75P92J
A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
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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.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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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.
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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.
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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.
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UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
8 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient 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?
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💲 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 system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.213 | $12.77 / 60 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.4049 | $24.29 / 60 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.5958 | $35.75 / 60 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Tolterodine Tartrate 1 mg 59762-0170-01 | Mylan | 500 tablets | $0.204 | AB | Discontinued | save 4% |
| Tolterodine Tartrate 1 mg 00093-0010-06 | Teva | 60 tablets | $0.213 | AB | Availability likely | — |
| Tolterodine tartrate 1 mgthis 33342-0097-09 | Macleods | 60 tablets | $0.213 | AB | Availability likely | — |
| Tolterodine Tartrate 1 mg 16571-0126-01 | Rising | 100 tablets | — | AB | FDA listed | — |
| Tolterodine Tartrate 1 mg 29300-0239-05 | Unichem | 500 tablets | — | AB | FDA listed | — |
| Tolterodine Tartrate 1 mg 31722-0805-01 | Camber | 10 tablets | — | AB | FDA listed | — |
| Detrol 1 mg 58151-0098-91 | Viatris | 60 tablets | — | AB | Discontinued | — |
| Tolterodine Tartrate 1 mg 71205-0319-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
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?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 33342-0097-09 You're viewing this | 60 TABLET, FILM COATED in 1 BOTTLE (33342-097-09) | $0.2128 / ea | $12.77 | 2020-10-08 | Active |
| 33342-0097-12 | 10 BLISTER PACK in 1 CARTON (33342-097-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK | — | — | 2020-10-08 | Active |
| 33342-0097-15 | 500 TABLET, FILM COATED in 1 BOTTLE (33342-097-15) | $0.2128 / ea | $106.41 | 2020-10-08 | Active |
This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.2128 NADAC).
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 33342-0097-09?
What is the difference between NDC 33342-0097-09 and NDC 33342-0097-15?
What NDC number is used to bill for this package of Tolterodine tartrate 1 mg Tablet, Film Coated?
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
🎯 Indications and Usage ▾
INDICATIONS & USAGE Tolterodine tartrate tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
⏱️ Dosage and Administration ▾
DOSAGE & ADMINISTRATION The initial recommended dose of tolterodine tartrate tablets is 2 mg twice daily. The dose may be lowered to 1 mg twice daily based on individual response and tolerability. For patients with significantly reduced hepatic or renal function or who are currently taking drugs that are potent inhibitors of CYP3A4, the recommended dose of tolterodine tartrate is 1 mg twice daily (see PRECAUTIONS , General , PRECAUTIONS, Reduced Hepatic and Renal Function , and PRECAUTIONS, Drug Interactions ).
⛔ Contraindications ▾
CONTRAINDICATIONS Tolterodine tartrate tablets are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. Tolterodine tartrate is also contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients, or to fesoterodine fumarate extended-release tablets which, like tolterodine tartrate, are metabolized to 5-hydroxymethyl tolterodine.
⚠️ Warnings ▾
WARNINGS Anaphylaxis and angioedema requiring hospitalization and emergency medical treatment have occurred with the first or subsequent doses of tolterodine tartrate. In the event of difficulty in breathing, upper airway obstruction, or fall in blood pressure, tolterodine tartrate should be discontinued and appropriate therapy promptly provided.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The Phase 2 and 3 clinical trial program for tolterodine tartrate tablets included 3071 patients who were treated with tolterodine tartrate (N=2133) or placebo (N=938). The patients were treated with 1, 2, 4, or 8 mg/day for up to 12 months. No differences in the safety profile of tolterodine were identified based on age, gender, race, or metabolism.
The data described below reflect exposure to tolterodine tartrate 2 mg bid in 986 patients and to placebo in 683 patients exposed for 12 weeks in five Phase 3, controlled clinical studies. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and approximating rates.
Sixty-six percent of patients receiving tolterodine tartrate 2 mg bid reported adverse events versus 56% of placebo patients. The most common adverse events reported by patients receiving tolterodine tartrate were dry mouth, headache, constipation, vertigo/dizziness, and abdominal pain. Dry mouth, constipation, abnormal vision (accommodation abnormalities), urinary retention, and xerophthalmia are expected side effects of antimuscarinic agents.
Dry mouth was the most frequently reported adverse event for patients treated with tolterodine tartrate 2 mg bid in the Phase 3 clinical studies, occurring in 34.8% of patients treated with tolterodine tartrate and 9.8% of placebo-treated patients. One percent of patients treated with tolterodine tartrate discontinued treatment due to dry mouth. The frequency of discontinuation due to adverse events was highest during the first 4 weeks of treatment.
Seven percent of patients treated with tolterodine tartrate 2 mg bid discontinued treatment due to adverse events versus 6% of placebo patients. The most common adverse events leading to discontinuation of tolterodine tartrate were dizziness and headache. Three percent of patients treated with tolterodine tartrate 2 mg bid reported a serious adverse event versus 4% of placebo patients.
Significant ECG changes in QT and QTc have not been demonstrated in clinical-study patients treated with tolterodine tartrate 2 mg bid. Table 5 lists the adverse events reported in 1% or more of the patients treated with tolterodine tartrate 2 mg bid in the 12-week studies. The adverse events are reported regardless of causality.
Table 5. Incidence* (%) of Adverse Events Exceeding Placebo Rate and Reported in >1% of Patients Treated with tolterodine tartrate tablets (2 mg bid) in 12 week, Phase 3 Clinical Studies Body System Adverse Event % Tolterodine tartrate N=986 % PlaceboN=683 Autonomic Nervous accommodation abnormal dry mouth 235 110 General chest pain fatigue headache influenza-like symptoms 2473 1352 Central/Peripheral Nervous vertigo/dizziness 5 3 Gastrointestinal abdominal pain constipation diarrhea dyspepsia 5744 3431 Urinary dysuria 2 1 Skin/Appendages dry skin 1 0 Musculoskeletal arthralgia 2 1 Vision xerophthalmia 3 2 Psychiatric somnolence 3 2 Metabolic/Nutritional weight gain 1 0 Resistance Mechanism infection 1 0 *in nearest integer.
Post-marketing Surveillance The following events have been reported in association with tolterodine use in worldwide post-marketing experience: General: anaphylaxis and angioedema; Cardiovascular: tachycardia, palpitations, peripheral edema; Central/Peripheral Nervous: confusion, disorientation, memory impairment, hallucinations. Reports of aggravation of symptoms of dementia (e.g., confusion, disorientation, delusion) have been reported after tolterodine therapy was initiated in patients taking cholinesterase inhibitors for the treatment of dementia.
Because these spontaneously reported events are from the worldwide post-mark…
🔄 Drug Interactions ▾
Drug Interactions CYP3A4 Inhibitors: Ketoconazole, an inhibitor of the drug metabolizing enzyme CYP3A4, significantly increased plasma concentrations of tolterodine when coadministered to subjects who were poor metabolizers (see CLINICAL PHARMACOLOGY , Variability in Metabolism and Drug-Drug Interactions ). For patients receiving ketoconazole or other potent CYP3A4 inhibitors such as other azole antifungals (e.g., itraconazole, miconazole) or macrolide antibiotics (e.g., erythromycin, clarithromycin) or cyclosporine or vinblastine, the recommended dose of tolterodine tartrate is 1 mg twice daily (see DOSAGE AND ADMINISTRATION ).
🔄 Drug / Laboratory Test Interactions ▾
Drug- Laboratory Test Interactions Interactions between tolterodine and laboratory tests have not been studied.
🤰 Pregnancy ▾
Pregnancy Pregnancy Category C. At oral doses of 20 mg/kg/day (approximately 14 times the human exposure), no anomalies or malformations were observed in mice. When given at doses of 30 to 40 mg/kg/day, tolterodine has been shown to be embryolethal, reduce fetal weight, and increase the incidence of fetal abnormalities (cleft palate, digital abnormalities, intra-abdominal hemorrhage, and various skeletal abnormalities, primarily reduced ossification) in mice.
At these doses, the AUC values were about 20- to 25-fold higher than in humans. Rabbits treated subcutaneously at a dose of 0.8 mg/kg/day achieved an AUC of 100 µg•h/L, which is about 3-fold higher than that resulting from the human dose. This dose did not result in any embryotoxicity or teratogenicity.
There are no studies of tolterodine in pregnant women. Therefore, tolterodine tartrate should be used during pregnancy only if the potential benefit for the mother justifies the potential risk to the fetus.
🧒 Pediatric Use ▾
Pediatric Use Efficacy in the pediatric population has not been demonstrated. Two pediatric phase 3 randomized, placebo-controlled, double-blind, 12-week studies were conducted using tolterodine extended release (DETROL LA) capsules. A total of 710 pediatric patients (486 on DETROL LA and 224 on placebo) aged 5–10 years with urinary frequency and urge urinary incontinence were studied.
The percentage of patients with urinary tract infections was higher in patients treated with DETROL LA (6.6%) compared to patients who received placebo (4.5%). Aggressive, abnormal, and hyperactive behavior and attention disorders occurred in 2.9% of children treated with DETROL LA compared to 0.9% of children treated with placebo.
🧓 Geriatric Use ▾
Geriatric Use Of the 1120 patients who were treated in the four Phase 3, 12-week clinical studies of tolterodine tartrate, 474 (42%) were 65 to 91 years of age. No overall differences in safety were observed between the older and younger patients (see CLINICAL PHARMACOLOGY , Pharmacokinetics in Special Populations ).
🆘 Overdosage ▾
OVERDOSAGE A 27-month-old child who ingested 5 to 7 tolterodine tartrate tablets 2 mg was treated with a suspension of activated charcoal and was hospitalized overnight with symptoms of dry mouth. The child fully recovered. Management of Overdosage Overdosage with tolterodine tartrate can potentially result in severe central anticholinergic effects and should be treated accordingly.
ECG monitoring is recommended in the event of overdosage. In dogs, changes in the QT interval (slight prolongation of 10% to 20%) were observed at a suprapharmacologic dose of 4.5 mg/kg, which is about 68 times higher than the recommended human dose. In clinical trials of normal volunteers and patients, QT interval prolongation was observed with tolterodine immediate release at doses up to 8 mg (4 mg bid) and higher doses were not evaluated (see PRECAUTIONS, Patients with Congenital or Acquired QT Prolongation ).
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Tolterodine is a competitive muscarinic receptor antagonist. Both urinary bladder contraction and salivation are mediated via cholinergic muscarinic receptors. After oral administration, tolterodine is metabolized in the liver, resulting in the formation of the 5-hydroxymethyl derivative, a major pharmacologically active metabolite.
The 5-hydroxymethyl metabolite, which exhibits an antimuscarinic activity similar to that of tolterodine, contributes significantly to the therapeutic effect. Both tolterodine and the 5-hydroxymethyl metabolite exhibit a high specificity for muscarinic receptors, since both show negligible activity or affinity for other neurotransmitter receptors and other potential cellular targets, such as calcium channels. Tolterodine has a pronounced effect on bladder function.
Effects on urodynamic parameters before and 1 and 5 hours after a single 6.4 mg dose of tolterodine immediate release were determined in healthy volunteers. The main effects of tolterodine at 1 and 5 hours were an increase in residual urine, reflecting an incomplete emptying of the bladder, and a decrease in detrusor pressure. These findings are consistent with an antimuscarinic action on the lower urinary tract.
Pharmacokinetics Absorption: In a study with 14 C-tolterodine solution in healthy volunteers who received a 5 mg oral dose, at least 77% of the radiolabeled dose was absorbed. Tolterodine immediate release is rapidly absorbed, and maximum serum concentrations (C max ) typically occur within 1 to 2 hours after dose administration. C max and area under the concentration-time curve (AUC) determined after dosage of tolterodine immediate release are dose-proportional over the range of 1 to 4 mg.
Effect of Food: Food intake increases the bioavailability of tolterodine (average increase 53%), but does not affect the levels of the 5-hydroxymethyl metabolite in extensive metabolizers. This change is not expected to be a safety concern and adjustment of dose is not needed. Distribution: Tolterodine is highly bound to plasma proteins, primarily α1-acid glycoprotein.
Unbound concentrations of tolterodine average 3.7% ± 0.13% over the concentration range achieved in clinical studies. The 5-hydroxymethyl metabolite is not extensively protein bound, with unbound fraction concentrations averaging 36% ± 4.0%. The blood to serum ratio of tolterodine and the 5-hydroxymethyl metabolite averages 0.6 and 0.8, respectively, indicating that these compounds do not distribute extensively into erythrocytes.
The volume of distribution of tolterodine following administration of a 1.28 mg intravenous dose is 113 ±
26.7L. Metabolism: Tolterodine is extensively metabolized by the liver following oral dosing. The primary metabolic route involves the oxidation of the 5-methyl group and is mediated by the cytochrome P450 2D6 (CYP2D6) and leads to the formation of a pharmacologically active 5-hydroxymethyl metabolite.
Further metabolism leads to formation of the 5-carboxylic acid and N-dealkylated 5-carboxylic acid metabolites, which account for 51% ± 14% and 29% ± 6.3% of the metabolites recovered in the urine, respectively. Variability in Metabolism: A subset (about 7%) of the population is devoid of CYP2D6, the enzyme responsible for the formation of the 5-hydroxymethyl metabolite of tolterodine. The identified pathway of metabolism for these individuals ("poor metabolizers") is dealkylation via cytochrome P450 3A4 (CYP3A4) to N-dealkylated tolterodine.
The remainder of the population is referred to as "extensive metabolizers." Pharmacokinetic studies revealed that tolterodine is metabolized at a slower rate in poor metabolizers than in extensive metabolizers; this results in significantly higher serum concentrations of tolterodine and in negligible concentrations of the 5-hydroxymethyl metabolite. Excretion: Following administration of a 5 mg oral dose of 14 C-tolterodine solution to healthy volunteers, 77% of radioactivity was recovered…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Tolterodine tartrate tablets 1 mg (white to off white, round, biconvex, film-coated tablets debossed with 'CL60' on one side and plain on other side) and tolterodine tartrate tablets 2 mg (white to off white, round, biconvex, film-coated tablets debossed with 'CL61' on one side and plain on other side) are supplied as follows: Bottles of 60 1mg NDC 33342-097-09 2mg NDC 33342-098-09 Bottles of 500 1mg NDC 33342-097-15 2mg NDC 33342-098-15 Unit Dose Pack of 100 1mg NDC 33342-097-12 2 mg NDC 33342-098-12 Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].
All other trademarks are properties of their respective owners. Manufactured for : Macleods Pharma USA, Inc. Princeton, NJ 08540 Manufactured by : Macleods Pharmaceuticals Ltd.
Baddi, Himachal Pradesh, INDIA Revised: November 2022
📋 Description ▾
DESCRIPTION Tolterodine tartrate tablets contain tolterodine tartrate, USP. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-2-[3-[bis(1-methylethyl)-amino]1-phenylpropyl]-4-methylphenol[R-(R*,R*)]-2,3dihydroxybutanedioate (1:1) (salt).
The molecular formula of tolterodine tartrate is C 26 H 37 NO 7 , and its molecular weight is 475.6. The structural formula of tolterodine tartrate is represented below: Tolterodine tartrate, USP is a white, crystalline powder. The pKa value is 9.87 and the solubility in water is 12 mg/mL.
It is soluble in methanol, slightly soluble in ethanol, and practically insoluble in toluene. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Tolterodine tartrate tablets for oral administration contain 1 or 2 mg of tolterodine tartrate.
The inactive ingredients are colloidal silicon dioxide, dibasic calcium phosphate anhydrous, cellulose microcrystalline, hypromellose, magnesium stearate, sodium starch glycolate (pH 3.0 to 5.0), stearic acid, and titanium dioxide. structure
💬 Information for Patients ▾
Information for Patients Patients should be informed that antimuscarinic agents such as tolterodine tartrate tablets may produce the following effects: blurred vision, dizziness, or drowsiness. Patients should be advised to exercise caution in decisions to engage in potentially dangerous activities until the drug's effects have been determined.