Home › NDC Lookup › Ingredients › Tolterodine Tartrate › 59762-0170-01
⚪image loading
(from DailyMed)

Tolterodine Tartrate 1 mg Tablet, Film Coated, 500-count — NDC 59762-0170-1 (Billing 59762-0170-01)

by Mylan Pharmaceuticals Inc. · 500 TABLET, FILM COATED in 1 BOTTLE

This is a package of 500 tablets of Tolterodine Tartrate 1 mg Tablet, Film Coated from Mylan Pharmaceuticals Inc., no longer marketed (first marketed Jan 2014), no longer in the FDA NDC Directory; retail pharmacies pay about $0.2037 per tablet (NADAC).

NDC 59762-0170-01
🏷️ FDA NDC (as labeled) 59762-0170-1 billing pads the package segment with a zero
This package
Contains500-count Cost per ea$0.2037 NADAC Per package$101.85 / 500 tablets Pack sizes2 compare ↓
Product page 59762-0170-06 Also comes in: 60 tablets 59762-0170-6
Rx only Brand Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Aug 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 59762-0170-1
Product NDC 59762-0170
11-digit billing NDC 59762017001
NCPDP billing unit EA — each (per item)
RxCUI 855178, 855194
UNII 5T619TQR3R
UPC 0359762017062, 0359762080028
Application # NDA020771
SPL Set ID 9e432622-2e6f-4cf8-892f-510288dd50f2
Established class (EPC) Cholinergic Muscarinic Antagonist
Mechanism of action Cholinergic Muscarinic Antagonists
DEA schedule Non-controlled
Marketing category NDA AUTHORIZED GENERIC
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Aug 2026)
Marketing start 2014-01-21
Marketing end 2026-08-31
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 59762-0170-1 — a 5-4-1 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 package segment → 59762-0170-01. 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 $101.85 / 500 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 · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Oct 2021 Jul 2022 Jan 2024 May 2026 $0.890 $0.203
▼ Down 77% over the last 20 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 Per unit Per pack Marketing startMarketing endStatus
59762-0170-01 You're viewing this 500 TABLET, FILM COATED in 1 BOTTLE $0.2037 / ea $101.86 2014-01-21 — Discontinued by firm
59762-0170-06 59762-0170-6 Main listing 60 TABLET, FILM COATED in 1 BOTTLE $0.2039 / ea $12.23 2014-01-21 Aug 31, 2026 Discontinued by firm

You're viewing the largest of 2 pack sizes for this product.

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.2037 NADAC).

Pack size FAQ

What quantity is in this package?
This is a 500-count package — 500 tablet, film coated in 1 bottle.
How does this package differ from NDC 59762-0170-06?
Both are Tolterodine Tartrate 1 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 500-count one, while NDC 59762-0170-06 is the 60 tablets package. Per-ea NADAC also differs: $0.2037 here vs $0.2039 for the 60 tablets pack.
What NDC number is used to bill for this package of Tolterodine Tartrate 1 mg Tablet, Film Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tolterodine Tartrate 1 mgthis 59762-0170-01 Mylan 500 tablets $0.204 AB Discontinued —
Tolterodine Tartrate 1 mg 00093-0010-06 Teva 60 tablets $0.204 AB Availability likely +0%
Tolterodine tartrate 1 mg 33342-0097-09 Macleods 60 tablets $0.204 AB Availability likely +0%
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 an authorized generic — the brand-name product marketed without its brand name. 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

🏛️
2014
On the market since
Jan 2014
📍
2026
Currently FDA-listed
12 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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

Inactive Ingredients / Excipients

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

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerMylan Pharmaceuticals Inc.
Application holderUPJOHN US 2 LLC
FDA applicationNDA020771 (NDA AUTHORIZED GENERIC)
Labeler code59762
First marketedJan 2014
Product typeHuman Prescription Drug
Portfolio473 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. 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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 23 words ▾

INDICATIONS AND USAGE Tolterodine tartrate tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

⏱️ Dosage and Administration 81 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 tablets is 1 mg twice daily (see PRECAUTIONS, General , PRECAUTIONS, Reduced Hepatic and Renal Function , and PRECAUTIONS, Drug Interactions ).

⛔ Contraindications 51 words ▾

CONTRAINDICATIONS Tolterodine tartrate tablets are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. Tolterodine tartrate 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 tartrate tablets, are metabolized to 5-hydroxymethyl tolterodine.

⚠️ Warnings 48 words ▾

WARNINGS Anaphylaxis and angioedema requiring hospitalization and emergency medical treatment have occurred with the first or subsequent doses of tolterodine tartrate tablets. In the event of difficulty in breathing, upper airway obstruction, or fall in blood pressure, tolterodine tartrate 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 tartrate tablets included 3071 patients who were treated with tolterodine tartrate tablets (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 tablets 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 tablets 2 mg bid reported adverse events versus 56% of placebo patients. The most common adverse events reported by patients receiving tolterodine tartrate tablets 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 tablets 2 mg bid in the Phase 3 clinical studies, occurring in 34.8% of patients treated with tolterodine tartrate tablets and 9.8% of placebo-treated patients. One percent of patients treated with tolterodine tartrate tablets 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 tablets 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 tablets were dizziness and headache. Three percent of patients treated with tolterodine tartrate tablets 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 tablets 2 mg bid. Table 5 lists the adverse events reported in 1% or more of the patients treated with tolterodine tartrate tablets 2 mg bid in the 12-week studies. The adverse events are reported regardless of causality.

Table 5. Incidence in nearest integer. (%) of Adverse Events Exceeding Placebo Rate and Reported in >1% of Patients Treated with Tolterodine TartrateTablets (2 mg bid) in 12-week, Phase 3 Clinical Studies Body System Adverse Event % Tolterodine Tartrate Tablets 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 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 in… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 82 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 tartrate tablets is 1 mg twice daily (see DOSAGE AND ADMINISTRATION ).

🔄 Drug / Laboratory Test Interactions 12 words ▾

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

🤰 Pregnancy 148 words ▾

Pregnancy Tolterodine, administered at oral doses of 20 mg/kg/day (approximately 14 times the human exposure), showed no anomalies or malformations 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 tablets should be used during pregnancy only if the potential benefit for the mother justifies the potential risk to the fetus.

🧒 Pediatric Use 108 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 tartrate extended-release capsules 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 tolterodine tartrate 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 tartrate 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 tartrate tablets, 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 140 words ▾

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 tablets 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% ± 4.0%. 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 in… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 108 words ▾

HOW SUPPLIED Tolterodine Tartrate Tablets 1 mg (white, round, biconvex, film-coated tablets engraved with arcs above and below the letters “TO”) and Tolterodine Tartrate Tablets 2 mg (white, round, biconvex, film-coated tablets engraved with arcs above and below the letters “DT”) are supplied as follows: Bottles of 60 1 mg NDC 59762-0170-6 2 mg NDC 59762-0800-2 Bottles of 500 1 mg NDC 59762-0170-1 2 mg NDC 59762-0800-6 Store at 25ºC (77ºF); excursions permitted to 15–30ºC (59–86ºF) [see USP Controlled Room Temperature].

GREENSTONE ® BRAND Distributed by: Greenstone LLC Morgantown, WV 26505 U.S.A. © 2024 Viatris Inc. The brands listed are trademarks of their respective owners. GST:TOLT:R1 Revised: 9/2024

📋 Description 151 words ▾

DESCRIPTION Tolterodine tartrate tablets contain 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).

The empirical 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 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 anhydrous silica, calcium hydrogen phosphate dihydrate, cellulose microcrystalline, hypromellose, magnesium stearate, sodium starch glycolate (pH 3.0 to 5.0), stearic acid, and titanium dioxide. structural formula of tolterodine tartrate

💬 Information for Patients 47 words ▾

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.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General Risk of Urinary Retention and Gastric Retention Tolterodine tartrate 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 tartrate tablets, like other antimuscarinic drugs, should be used with caution in patients with decreased gastrointestinal motility.

Controlled Narrow-Angle Glaucoma Tolterodine tartrate tablets should be used with caution in patients being treated for narrow-angle glaucoma. Central Nervous System (CNS) Effects Tolterodine tartrate tablets is 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 tartrate tablets is 1 mg twice daily (see CLINICAL PHARMACOLOGY, Pharmacokinetics in Special Populations ).

Myasthenia Gravis Tolterodine tartrate tablets 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 (PM) 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 tartrate tablets 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 post-marketing experience with tolterodine tartrate tablets or tolterodine tartrate extended-release capsules. 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.

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 tablets 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 Carcinogeni… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 77 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 tartrate tablets should not be administered during nursing. A decision should be made whether to discontinue nursing or to discontinue tolterodine tartrate tablets 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% ± 4.0%. 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 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 C max = Maximum plasma concentration; t max = Time of occurrence of C max ; C avg = Average plasma concentration; t1/2 = Terminal elimination half-life; CL/F = Apparent oral clearance. EM = Extensive metabolizers; PM = Poor metabolizers. † = not applicable.

Tolterodine 5-Hydroxymethyl Metabolite Phenotype (CYP2D6) t max (h) C max Parameter was dose-normalized from 4 mg to 2 mg. (µg/L) C avg (µg/L) t 1/2 (h) CL/F (L/h) t max (h) C max (µg/L) C avg (µg/L) t 1/2 (h) Single-dose EM PM 1.6±1.5 1.4±0.5… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

CLINICAL STUDIES Tolterodine tartrate 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 tartrate tablets 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 Tartrate Tablets (2 mg bid) and Placebo for the Mean Change at Week 12 from Baseline in Study 007 SD = Standard Deviation. Tolterodine Tartrate Tablets (SD) N=514 Placebo (SD) N=508 Difference (95% CI) Number of Incontinence Episodes per Week Mean baseline Mean change from baseline 23.2 -10.6 (17) 23.3 -6.9 (15) -3.7 (-5.7, -1.6) Number of Micturitions per 24 Hours Mean baseline Mean change from baseline 11.1 -1.7 (3.3) 11.3 -1.2 (2.9) -0.5 The difference between tolterodine tartrate tablets and placebo was statistically significant.

(-0.9, -0.1) Volume Voided per Micturition (mL) Mean baseline Mean change from baseline 137 29 (47) 136 14 (41) 15 (9,21) Table 4. 95% Confidence Intervals (CI) for the Difference between Tolterodine Tartrate Tablets (2 mg bid) and Placebo for the Mean Change at Week 12 from Baseline in Studies 008, 009, 010 SD = Standard Deviation. Study Tolterodine Tartrate Tablets (SD) Placebo (SD) Difference (95% CI) Number of Incontinence Episodes per 24 Hours 008 Number of patients Mean baseline Mean change from baseline 93 2.9 -1.3 (3.2) 40 3.3 -0.9 (1.5) 0.5 (-1.3,0.3) 009 Number of patients Mean baseline Mean change from baseline 116 3.6 -1.7 (2.5) 55 3.5 -1.3 (2.5) -0.4 (-1.0,0.2) 010 Number of patients Mean baseline Mean change from baseline 90 3.7 -1.6 (2.4) 50 3.5 -1.1 (2.1) -0.5 (-1.1,0.1) Number of Micturitions per 24 Hours 008 Number of patients Mean baseline Mean change from baseline 118 11.5 -2.7 (3.8) 56 11.7 -1.6 (3.6) -1.2 The difference between tolterodine tartrate tablets and placebo was statistically significant.

(-2.0,-0.4) 009 Number of patients Mean baseline Mean change from baseline 128 11.2 -2.3 (2.1) 64 11.3 -1.4 (2.8) -0.9 (-1.5,-0.3) 010 Number of patients Mean baseline Mean change from baseline 108 11.6 -1.7 (2.3) 56 11.6 -1.4 (2.8) -0.38 (-1.1,0.3) Volume Voided per Micturition (mL) 008 Number of patients Mean baseline Mean change from baseline 118 166 38 (54) 56 157 6 (42) 32 (18,46) 009 Number of patients Mean baseline Mean change from baseline 129 155 36 (50) 64 158 10 (47) 26 (14,38) 010 Number of patients Mean baseline Mean change from baseline 108 155 31 (45) 56 160 13 (52) 18 (4,32)

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 220 words ▾

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 µg·h/L, respectively. In comparison, the human AUC value for a 2 mg dose administered twice daily is estimated at 34 µg·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 µg·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.

📄 Package Label / Principal Display Panel 154 words ▾

PRINCIPAL DISPLAY PANEL – 1 mg NDC 59762-0170-6 60 Tablets GREENSTONE ® BRAND tolterodine tartrate tablets 1 mg Rx only Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Dispense in tight containers (USP). DOSAGE AND USE: See accompanying prescribing information.

Each tablet contains 1 mg tolterodine tartrate. Distributed by: Greenstone LLC Morgantown, WV 26505 U.S.A. © 2024 Viatris Inc. Made In Italy RGST0170D1 PAA236349 Tolterodine Tartrate Tablets 1 mg Bottle Label

PRINCIPAL DISPLAY PANEL – 2 mg NDC 59762-0800-2 60 Tablets GREENSTONE ® BRAND tolterodine tartrate tablets 2 mg Rx only Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Dispense in tight containers (USP). DOSAGE AND USE: See accompanying prescribing information.

Each tablet contains 2 mg tolterodine tartrate. Distributed by: Greenstone LLC Morgantown, WV 26505 U.S.A. © 2024 Viatris Inc. Made In Italy RGST0800D1 PAA236348 Tolterodine Tartrate Tablets 2 mg Bottle Label

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

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
60 tablets59762-0170-06 33 Rx · $547
500 tablets this page59762-0170-01 No Medicaid data
Drug total (last 4 qtrs): 33 Rx · 2,202 units · $547 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for 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.

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 60 tablets (59762-0170-06). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Mylan Pharmaceuticals Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 59762-0131-00 · Mylan 59762-0260-01 · Mylan →
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.