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Tolterodine Tartrate 1 mg Tablet, Film Coated, 60-count — NDC 0093-0010-06 (Billing 00093-0010-06)

by Teva Pharmaceuticals USA, Inc. · 60 TABLET, FILM COATED in 1 BOTTLE

This is a package of 60 tablets of Tolterodine Tartrate 1 mg Tablet, Film Coated from Teva Pharmaceuticals USA, Inc., marketed since Nov 2015 and currently FDA-listed; retail pharmacies pay about $0.2039 per tablet (NADAC). It is this product's only package size.

NDC 00093-0010-06
🏷️ FDA NDC (as labeled) 0093-0010-06 billing pads the labeler 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 →

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

NDC database record

One package, one record: these facts belong to NDC 0093-0010-06 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0093 labeler · 0010 product · 06 package
Package marketed since
Nov 1, 2015
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
60 EA per package
Barcode (UPC-A, from the NDC)
3 0093001006 4
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0093-0010-06
Product NDC 0093-0010
11-digit billing NDC 00093001006
NCPDP billing unit EA — each (per item)
RxCUI 855178, 855194
UNII 5T619TQR3R
Application # ANDA077006
SPL Set ID d27e25b5-5d02-419f-b098-41fb162c5872
Established class (EPC) Cholinergic Muscarinic Antagonist
Mechanism of action Cholinergic Muscarinic Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-11-01
Route ORAL
Dosage form TABLET, FILM COATED
Substance TOLTERODINE TARTRATE
TE code (Orange Book) AB · RLD · RS

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

GPI-14 54100060200320
GPI class Tolterodine Tartrate
GCN Seq No 039138
GCN 37061
HICL code 018047
Ingredient (HICL) Tolterodine Tartrate
HIC1 code R
Therapeutic class — broad (HIC1) Kidney/Urinary Tract
HIC2 code R1
Therapeutic class — intermediate (HIC2) Affect Primarily Kidneys/Urinary Tract
HIC3 code R1A
Therapeutic class — specific (HIC3) Urinary Tract Antispasmodic/Antiincontinence Agent
AHFS code 86:12.04.00
AHFS class Antimuscarinics
FDB label name TOLTERODINE TARTRATE 1 MG TAB
FDB brand name Tolterodine Tartrate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 039138
  • GCN: 37061
  • GPI-14 (Medi-Span): 54100060200320
  • HICL (First Databank): 018047
  • AHFS class code: 86:12.04.00
  • RxCUI (RxNorm): 855178
Why two NDCs? The FDA registers this code as 0093-0010-06 — a 4-4-2 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 labeler segment → 00093-0010-06. 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 Antagonist class.

Pharmacologic class Cholinergic Muscarinic Antagonist
Drug family (ATC) Drugs for urinary frequency and incontinence
How it works Cholinergic Muscarinic Antagonists
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 TOLTERODINE TARTRATE 1 MG TAB Ingredient Tolterodine Tartrate
📖 What it is MedlinePlus · NLM

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 ↗
📗 Our plain-language guide HelloPharmacist
  • It treats overactive bladder, meaning sudden urges to urinate, leaking with those urges, and going very often. It helps calm the bladder muscle.
  • It is taken by mouth. If you have the extended-release capsule, such as Detrol LA, take it once daily with water and swallow it whole. Follow your label and prescriber for your exa...
  • Dry mouth is the most common. Headache, constipation, dizziness, stomach pain and dry or blurry eyes can also happen. Tell me if any of them bother you.
  • Get emergency help for swelling of the face, lips or throat, or trouble breathing. Call your doctor if you cannot pass urine, or if you notice confusion, hallucinations, or a fast...
📖 Read our full Tolterodine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 $0.204 $12.23 / 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 $0.5958 $35.75 / 60 tablets
NADAC price history (per ea) — tap or hover for the price & month
Oct 2021 Aug 2022 Jan 2026 Sep 2026 $0.890 $0.200
▼ Down 77% 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00093-0010-06 You're viewing this Main listing 60 TABLET, FILM COATED in 1 BOTTLE 2015-11-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tolterodine Tartrate 1 mg 59762-0170-01 Mylan 500 tablets $0.204 AB Discontinued +0%
Tolterodine Tartrate 1 mgthis 00093-0010-06 Teva 60 tablets $0.204 AB Availability likely —
Tolterodine tartrate 1 mg 33342-0097-09 Macleods 60 tablets $0.204 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 —
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

🏛️
2015
On the market since
Nov 2015
📍
2026
Currently FDA-listed
11 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.

What it looks like

Color white
ShapeRound
Imprint93;18
Size6 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.

🧪 Avoiding an ingredient? See Tolterodine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • 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 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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?
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

LabelerTeva Pharmaceuticals USA, Inc.
Application holderIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
FDA applicationANDA077006 (ANDA)
Labeler code00093
First marketedNov 2015
Product typeHuman Prescription Drug
Portfolio504 products on file

More NDCs from Teva Pharmaceuticals USA, Inc. labeler code 00093

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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🔄 Drug / Laboratory Test Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 22 words ▾

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 82 words ▾

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 48 words ▾

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 46 words ▾

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 ~3 min read ▾

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… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 79 words ▾

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 13 words ▾

Drug-Laboratory Test Interactions Interactions between tolterodine and laboratory tests have not been studied.

🤰 Pregnancy 152 words ▾

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 107 words ▾

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 51 words ▾

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 138 words ▾

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 ~3 min read ▾

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… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 149 words ▾

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 132 words ▾

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 45 words ▾

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.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General Risk of Urinary Retention and Gastric Retention Tolterodine tablets should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention and to patients with gastrointestinal obstructive disorders, such as pyloric stenosis, because of the risk of gastric retention (see CONTRAINDICATIONS ). Decreased Gastrointestinal Motility Tolterodine, like other antimuscarinic drugs, should be used with caution in patients with decreased gastrointestinal motility.

Controlled Narrow-Angle Glaucoma Tolterodine should be used with caution in patients being treated for narrow-angle glaucoma. Central Nervous System (CNS) Effects Tolterodine tablets are associated with anticholinergic central nervous system (CNS) effects including dizziness and somnolence (see ADVERSE REACTIONS ). Patients should be monitored for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing the dose.

Advise patients not to drive or operate heavy machinery until the drug’s effects have been determined. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered. Reduced Hepatic and Renal Function For patients with significantly reduced hepatic function or renal function, the recommended dose of tolterodine is 1 mg twice daily (see CLINICAL PHARMACOLOGY , Pharmacokinetics in Special Populations ).

Myasthenia Gravis Tolterodine should be used with caution in patients with myasthenia gravis, a disease characterized by decreased cholinergic activity at the neuromuscular junction. Patients With Congenital or Acquired QT Prolongation In a study of the effect of tolterodine immediate-release tablets on the QT interval (see CLINICAL PHARMACOLOGY , Cardiac Electrophysiology ), the effect on the QT interval appeared greater for 8 mg/day (two times the therapeutic dose) compared to 4 mg/day and was more pronounced in CYP2D6 poor metabolizers (PMs) than extensive metabolizers (EMs).

The effect of tolterodine 8 mg/day was not as large as that observed after four days of therapeutic dosing with the active control moxifloxacin. However, the confidence intervals overlapped. These observations should be considered in clinical decisions to prescribe tolterodine for patients with a known history of QT prolongation or patients who are taking Class IA (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications (see PRECAUTIONS , Drug Interactions ).

There has been no association of Torsade de pointes in the international postmarketing experience with tolterodine tablets or tolterodine extended-release capsules. 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.

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 Interactions between tolterodine and laboratory tests have not been studied. Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies with tolterodine were conducted in mice and rats. At the maximum tolerated dose in mice (30 mg/kg/day), female rats (20 mg/kg/day), and ma… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 73 words ▾

Nursing Mothers Tolterodine is excreted into the milk in mice. Offspring of female mice treated with tolterodine 20 mg/kg/day during the lactation period had slightly reduced body weight gain. The offspring regained the weight during the maturation phase.

It is not known whether tolterodine is excreted in human milk; therefore, tolterodine should not be administered during nursing. A decision should be made whether to discontinue nursing or to discontinue tolterodine in nursing mothers.

🧬 Pharmacokinetics ~3 min read ▾

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 urine and 17% was recovered in feces in 7 days.

Less than 1% (< 2.5% in poor metabolizers) of the dose was recovered as intact tolterodine, and 5% to 14% (< 1% in poor metabolizers) was recovered as the active 5-hydroxymethyl metabolite. A summary of mean (± standard deviation) pharmacokinetic parameters of tolterodine immediate-release and the 5-hydroxymethyl metabolite in extensive (EM) and poor (PM) metabolizers is provided in Table 1 . These data were obtained following single- and multiple-doses of tolterodine 4 mg administered twice daily to 16 healthy male volunteers (8 EM, 8 PM).

Table 1: Summary of Mean (± SD) Pharmacokinetic Parameters of Tolterodine and its Active Metabolite (5-hydroxymethyl metabolite) in Healthy Volunteers Tolterodine 5-Hydroxymethyl Metabolite Phenotype (CYP2D6) t max (h) C max 1 (mcg/L) C avg 1 (mcg/L) t 1/2 (h) CL/F (L/h) t max (h) C max 1 (mcg/L) C avg 1 (mcg/L) t 1/2 (h) Single-dose EM 1.6±1.5 1.6±1.2 0.50±0.35 2±0.7 534±697 1.8±1.4 1.8±0.7 0.62±0.26 3.1±0.7 PM 1.4±0.5 10±4.9 8.3±4.3 6.5±1.6 17±7.3 2 2 2 2 Multiple-dose EM 1.2±0.5 2.6±2.8 0.58±0.54 2.2±0.4 415±377 1.2±0.5 2.4±1.3 0.92±0.46 2.9±0.4 PM 1.9±1 19±7.5 12±5.1 9.6±1.5 11±4.2 2 2 2 2 1.

Parameter was dose-normalized from 4 mg to 2… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

CLINICAL STUDIES Tolterodine tablets were evaluated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency in four randomized, double-blind, placebo-controlled, 12 week studies. A total of 853 patients received tolterodine 2 mg twice daily and 685 patients received placebo. The majority of patients were Caucasian (95%) and female (78%), with a mean age of 60 years (range, 19 to 93 years).

At study entry, nearly all patients perceived they had urgency and most patients had increased frequency of micturitions and urge incontinence. These characteristics were well balanced across treatment groups for the studies. The efficacy endpoints for study 007 (see Table 3 ) included the change from baseline for: Number of incontinence episodes per week Number of micturitions per 24 hours (averaged over 7 days) Volume of urine voided per micturition (averaged over 2 days) The efficacy endpoints for studies 008, 009, and 010 (see Table 4 ) were identical to the above endpoints with the exception that the number of incontinence episodes was per 24 hours (averaged over 7 days).

Table 3: 95% Confidence Intervals (CI) for the Difference Between Tolterodine (2 mg BID) and Placebo for the Mean Change at Week 12 From Baseline in Study 007 Tolterodine (SD) N = 514 Placebo (SD) N = 508 Difference (95% CI) Number of Incontinence Episodes per Week Mean baseline 23.2

23.3Mean change from baseline -10.6 (17) -6.9 (15) -3.7 (-5.7, -1.6) Number of Micturitions per 24 Hours Mean baseline 11.1

11.3Mean change from baseline -1.7 (3.3) -1.2 (2.9) -0.51 (-0.9, -0.1) Volume Voided per Micturition (mL) Mean baseline 137 136 Mean change from baseline 29 (47) 14 (41) 151 (9, 21) 1. The difference between tolterodine and placebo was statistically significant SD = Standard Deviation Table 4: 95% Confidence Intervals (CI) for the Difference Between Tolterodine (2 mg BID) and Placebo for the Mean Change at Week 12 From Baseline in Studies 008, 009, 010 Study Tolterodine (SD) Placebo (SD) Difference (95% CI) Number of Incontinence Episodes per 24 Hours 008 Number of patients 93 40 Mean baseline 2.9

3.3Mean change from baseline -1.3 (3.2) -0.9 (1.5) 0.5 (-1.3, 0.3) 009 Number of patients 116 55 Mean baseline 3.6

3.5Mean change from baseline -1.7 (2.5) -1.3 (2.5) -0.4 (-1, 0.2) 010 Number of patients 90 50 Mean baseline 3.7

3.5Mean change from baseline -1.6 (2.4) -1.1 (2.1) -0.5 (-1.1, 0.1) Number of Micturitions per 24 Hours 008 Number of patients 118 56 Mean baseline 11.5

11.7Mean change from baseline -2.7 (3.8) -1.6 (3.6) -1.21 (-2, -0.4) 009 Number of patients 128 64 Mean baseline 11.2

11.3Mean change from baseline -2.3 (2.1) -1.4 (2.8) -0.91 (-1.5, -0.3) 010 Number of patients 108 56 Mean baseline 11.6

11.6Mean change from baseline -1.7 (2.3) -1.4 (2.8) -0.38 (-1.1, 0.3) Volume Voided per Micturition (mL) 008 Number of patients 118 56 Mean baseline 166 157 Mean change from baseline 38 (54) 6 (42) 321 (18, 46) 009 Number of patients 129 64 Mean baseline 155 158 Mean change from baseline 36 (50) 10 (47) 261 (14, 38) 010 Number of patients 108 56 Mean baseline 155 160 Mean change from baseline 31 (45) 13 (52) 181 (4, 32) 1. The difference between tolterodine and placebo was statistically significant. SD = Standard Deviation

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies with tolterodine were conducted in mice and rats. At the maximum tolerated dose in mice (30 mg/kg/day), female rats (20 mg/kg/day), and male rats (30 mg/kg/day), AUC values obtained for tolterodine were 355, 291, and 462 mcg•h/L, respectively. In comparison, the human AUC value for a 2 mg dose administered twice daily is estimated at 34 mcg•h/L.

Thus, tolterodine exposure in the carcinogenicity studies was 9 to 14 fold higher than expected in humans. No increase in tumors was found in either mice or rats. No mutagenic effects of tolterodine were detected in a battery of in vitro tests, including bacterial mutation assays (Ames test) in 4 strains of Salmonella typhimurium and in 2 strains of Escherichia coli , a gene mutation assay in L5178Y mouse lymphoma cells, and chromosomal aberration tests in human lymphocytes.

Tolterodine was also negative in vivo in the bone marrow micronucleus test in the mouse. In female mice treated for 2 weeks before mating and during gestation with 20 mg/kg/day (corresponding to AUC value of about 500 mcg•h/L), neither effects on reproductive performance or fertility were seen. Based on AUC values, the systemic exposure was about 15 fold higher in animals than in humans.

In male mice, a dose of 30 mg/kg/day did not induce any adverse effects on fertility.

📄 Patient Package Insert ~3 min read ▾

TOLTERODINE TARTRATE TABLETS PATIENT INFORMATION TOLTERODINE (Tol-TER-oh-deen) TARTRATE (TAHR-trat) TABLETS Read the Patient Information that comes with tolterodine tartrate tablets before you start using them and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or your treatment.

Only your doctor can determine if treatment with tolterodine tartrate tablets is right for you. What are tolterodine tartrate tablets? Tolterodine tartrate tablets are a prescription medicine for adults used to treat the following symptoms due to a condition called overactive bladder : Urge urinary incontinence: a strong need to urinate with leaking or wetting accidents Urgency: a strong need to urinate right away Frequency: urinating often Tolterodine tartrate extended-release capsules did not help the symptoms of overactive bladder when studied in children.

What is overactive bladder? Overactive bladder happens when you cannot control your bladder muscle. When the muscle contracts too often or cannot be controlled, you get symptoms of overactive bladder, which are leakage of urine (urge urinary incontinence), needing to urinate right away (urgency), and needing to urinate often (frequency).

Who should not take tolterodine tartrate tablets? Do not take tolterodine tartrate tablets if you: Are not able to empty your bladder (urinary retention) Have delayed or slow emptying of your stomach (gastric retention) Have an eye problem called "uncontrolled narrow-angle glaucoma" Are allergic to tolterodine tartrate tablets or to any of its ingredients. See the end of this leaflet for a complete list of ingredients Are allergic to Toviaz ® (fesoterodine fumarate) which contains fesoterodine What should I tell my doctor before starting tolterodine tartrate tablets?

Before starting tolterodine tartrate tablets, tell your doctor about all of your medical and other conditions that may affect the use of tolterodine tartrate tablets, including: Stomach or intestinal problems or problems with constipation Problems emptying your bladder or if you have a weak urine stream Treatment for an eye problem called narrow-angle glaucoma Liver problems Kidney problems A condition called myasthenia gravis If you or any family members have a rare heart condition called QT prolongation (long QT syndrome) If you are pregnant or trying to become pregnant.

It is not known if tolterodine tartrate tablets could harm your unborn baby. If you are breastfeeding. It is not known if tolterodine tartrate tablets pass into your breast milk or if they can harm your baby.

Talk to your doctor about the best way to feed your baby if you take tolterodine tartrate tablets. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Other medicines can affect how your body handles tolterodine tartrate tablets.

Your doctor may use a lower dose of tolterodine tartrate tablets if you are taking: Certain medicines for fungus or yeast infections Certain medicines for bacterial infections Sandimmune ® (cyclosporine) or Velban ® (vinblastine) Ask your doctor or pharmacist for a list of these medicines, if you are not sure. Know the medicines you take. Keep a list of them with you to show your doctor or pharmacist each time you get a new medicine.

How should I take tolterodine tartrate tablets? Take tolterodine tartrate tablets exactly as your doctor tells you to take them. Your doctor will tell you how many tolterodine tartrate tablets to take and when to take them.

Do not change your dose unless told to do so by your doctor. You can take tolterodine tartrate tablets with or without food. Take tolterodine tartrate tablets at the same times each day.

If you miss a dose of tolterodine tartrate tablets, just take your next regular dose at your next regular time. Do not try to make up for your missed dose. If you take too many tolterodin… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 52 words ▾

Package/Label Display Panel NDC 0093- 0010 -06 Tolterodine Tartrate Tablets, 1 mg PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLET Rx only 60 TABLETS TEVA 1

Package/Label Display Panel NDC 0093- 0018 -06 Tolterodine Tartrate Tablets, 2 mg PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLET Rx only 60 TABLETS TEVA 2

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 Tolterodine Tartrate — 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 Tolterodine Tartrate. 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
$2.42M
Claims incl. refills
43.3K
Beneficiaries
25.8K
Spend / beneficiary
$93.68
Spend / claim
$55.77
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.
← 00088-2502-01 · sanofi-aventis 00093-0017-01 · Teva →
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.