Tolterodine Tartrate 2 mg Tablet, Film Coated, 60-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Cholinergic Muscarinic Antagonist class.
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🏭 Manufacturer & labeler
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🩺 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 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 M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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UNII 36SFW2JZ0W
Hypromellose 2910 is a plant-based thickening agent derived from cellulose. In medicines, it forms a protective coating on tablets or capsules and controls how quickly the drug dissolves and releases into your body.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 30IQX730WE
Polyethylene glycol 6000 is a synthetic polymer made from ethylene glycol units. It acts as a binder, filler, and solubilizer in medicines to help hold ingredients together, add bulk, and improve how well active drugs dissolve and absorb.
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UNII 7CV7WJK4UI
Sodium stearyl fumarate is a synthetic compound made from stearyl alcohol and fumaric acid. It acts as a lubricant and glidant in tablets and capsules, helping ingredients flow smoothly during manufacturing and preventing sticking.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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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.
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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
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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 | $0.248 | $14.90 / 60 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 | $0.5393 | $32.36 / 60 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Tolterodine Tartrate 2 mgthis 00093-0018-06 | Teva | 60 tablets | $0.248 | AB | Availability likely | — |
| Tolterodine tartrate 2 mg 33342-0098-09 | Macleods | 60 tablets | $0.248 | AB | Availability likely | — |
| Tolterodine Tartrate 2 mg 59762-0800-02 | Mylan | 60 tablets | $0.248 | AB | Discontinued | — |
| Tolterodine Tartrate 2 mg 16571-0127-01 | Rising | 100 tablets | — | AB | FDA listed | — |
| Tolterodine Tartrate 2 mg 29300-0240-01 | Unichem | 100 tablets | — | AB | FDA listed | — |
| Tolterodine Tartrate 2 mg 31722-0806-01 | Camber | 10 tablets | — | AB | FDA listed | — |
| Detrol 2 mg 58151-0099-91 | Viatris | 60 tablets | — | AB | FDA listed | — |
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⏳ 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?
📊 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 |
|---|---|---|---|---|---|
| 00093-0018-05 | 500 TABLET, FILM COATED in 1 BOTTLE (0093-0018-05) | $0.2483 / ea | $124.15 | 2015-11-01 | Active |
| 00093-0018-06 You're viewing this | 60 TABLET, FILM COATED in 1 BOTTLE (0093-0018-06) | $0.2483 / ea | $14.90 | 2015-11-01 | Active |
You're viewing the smallest of 2 pack sizes for this product.
This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.2483 NADAC).
Pack size FAQ
What quantity is in NDC 00093-0018-06?
What is the difference between NDC 00093-0018-06 and NDC 00093-0018-05?
What NDC number is used to bill for this package of Tolterodine Tartrate 2 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 AND USAGE Tolterodine tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
⏱️ Dosage and Administration ▾
DOSAGE AND 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 tablets are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. Tolterodine tablets are also contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients, or to fesoterodine fumarate extended-release tablets which, like tolterodine tablets, 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 tablets. In the event of difficulty in breathing, upper airway obstruction, or fall in blood pressure, tolterodine tablets should be discontinued and appropriate therapy promptly provided.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The Phase 2 and 3 clinical trial program for tolterodine tablets included 3071 patients who were treated with tolterodine (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 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 2 mg BID reported adverse events versus 56% of placebo patients. The most common adverse events reported by patients receiving tolterodine 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 2 mg BID in the Phase 3 clinical studies, occurring in 34.8% of patients treated with tolterodine and 9.8% of placebo-treated patients. One percent of patients treated with tolterodine 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 2 mg BID discontinued treatment due to adverse events versus 6% of placebo patients. The most common adverse events leading to discontinuation of tolterodine were dizziness and headache. Three percent of patients treated with tolterodine 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 2 mg BID. Table 5 lists the adverse events reported in 1% or more of the patients treated with tolterodine 2 mg BID in the 12 week studies. The adverse events are reported regardless of causality.
Table 5: Incidence1(%) of Adverse Events Exceeding Placebo Rate and Reported in > 1% of Patients Treated With Tolterodine Tablets (2 mg BID) in 12 week, Phase 3 Clinical Studies Body System Adverse Event % Tolterodine N = 986 % Placebo N = 683 Autonomic Nervous Accommodation abnormal 2 1 Dry mouth 35 10 General Chest pain 2 1 Fatigue 4 3 Headache 7 5 Influenza-like symptoms 3 2 Central/Peripheral Nervous Vertigo/dizziness 5 3 Gastrointestinal Abdominal pain 5 3 Constipation 7 4 Diarrhea 4 3 Dyspepsia 4 1 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 1. in nearest integer Postmarketing Surveillance The following events have been reported in association with tolterodine use in worldwide postmarketing 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 postmarketing experience, the frequency of events and the role of tolterodine in their causation cannot be reliably det…
🔄 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 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 Teratogenic Effects 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 mcg•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 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 capsules. A total of 710 pediatric patients (486 on tolterodine extended-release capsules and 224 on placebo) aged 5 to 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 tolterodine extended-release capsules (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 tolterodine extended-release capsules 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, 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 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 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 α 1 -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%. 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 in…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Tolterodine Tartrate Tablets, 1 mg, are available as white, round, unscored, biconvex, film-coated tablets, debossed with “93” on one side and “0010” on the other side containing 1 mg tolterodine tartrate, packaged in bottles of 60 (NDC 0093-0010-06) and 500 (NDC 0093-0010-05) tablets. Tolterodine Tartrate Tablets, 2 mg, are available as white, round, unscored, biconvex, film-coated tablets, debossed “93” on one side and “18” on the other side containing 2 mg tolterodine tartrate, packaged in bottles of 60 (NDC 0093-0018-06) and 500 (NDC 0093-0018-05) tablets.
PHARMACIST: Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Manufactured In India By: Cipla Ltd. Goa, India Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev.
D 4/2015
📋 Description ▾
DESCRIPTION This product contains tolterodine tartrate. 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).
It has the following structural formula: C 26 H 37 NO 7 M.W. 475.6 Tolterodine tartrate 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. Each tolterodine tartrate tablet, for oral administration, contains 1 mg or 2 mg of tolterodine tartrate.
In addition, each tablet contains the following inactive ingredients: corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, and titanium dioxide. tolterodine figure
💬 Information for Patients ▾
Information for Patients Patients should be informed that antimuscarinic agents such as tolterodine 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.