HomeNDC LookupIngredientsBenztropine Mesylate › 69315-0137-01
BENZTROPINE MESYLATE 1 mg Tablet, 100-count — NDC 69315-0137-01 package photo

BENZTROPINE MESYLATE 1 mg Tablet, 100-count

by Leading Pharma, LLC · 100 TABLET in 1 BOTTLE (69315-137-01)
NDC 69315-0137-01
🏷️ FDA NDC (as labeled) 69315-137-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.0764 NADAC Per package$7.64 / 100 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.2075/unit · Part D plans $0.1822/unit — full pricing hub ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 69315-137-01
Product NDC 69315-137
11-digit billing NDC 69315013701
NCPDP billing unit EA — each (per item)
RxCUI 885209, 885213, 885219
UNII WMJ8TL7510
UPC 0369315137109, 0369315137017, 0369315138014, 0369315136102 +2 more
Application # ANDA090168
SPL Set ID fe002ec4-07cb-41ca-a58c-33b3a8682101
Established class (EPC) Anticholinergic; Antihistamine
Mechanism of action Cholinergic Antagonists; Histamine Receptor Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-11-28
Route ORAL
Dosage form TABLET
Substance BENZTROPINE MESYLATE
GPI-14 73100010100310
GPI class Benztropine Mesylate
GCN Seq No 004590
GCN 17621
HICL code 001905
Ingredient (HICL) Benztropine Mesylate
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Midbrain
HIC3 code H6B
Therapeutic class — specific (HIC3) Antiparkinsonism Drugs,Anticholinergic
AHFS code 12:08.04.00
AHFS class Antiparkinsonian Agents
FDB label name BENZTROPINE MES 1 MG TABLET
FDB brand name Benztropine Mesylate
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AA · RLD · RS
Why two NDCs? The FDA registers this code as 69315-137-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 69315-0137-01. 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 Anticholinergic class.

Pharmacologic class Anticholinergic, Antihistamine
Drug family (ATC) Ethers of tropine or tropine derivatives
How it works Histamine Receptor Antagonists, Cholinergic 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.

🏭 Manufacturer & labeler

LabelerLeading Pharma, LLC
Application holderLEADING PHARMA LLC
FDA applicationANDA090168 (ANDA)
Labeler code69315
First marketedNov 2012
Product typeHuman Prescription Drug
Portfolio83 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name BENZTROPINE MES 1 MG TABLET Ingredient Benztropine Mesylate
📖 What it is MedlinePlus · NLM

Benztropine is used along with other medications to treat the symptoms of Parkinson's disease (PD; a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) and tremors caused by other medical problems or medications. Benztropine is in a class of medications called anticholinergics. It works by blocking a certain natural substance (acetylcholine) to help to decrease symptoms in people with Parkinson's disease.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Benztropine helps reduce the stiffness, tremors, and movement problems that come with parkinsonism. It works by blocking certain chemical signals in the brain that are out of balan...
  • What exactly is benztropine supposed to do for me?
  • This medication has a long-lasting effect, so many people do best taking their full dose at bedtime — it can help you move more comfortably during the night and make it easier to g...
  • Should I take my tablet in the morning or at night?
📖 Read our full Benztropine guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color White
ShapeRound
ImprintEP;138
Size7 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

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

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

  • UNII L11K75P92J
    A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
  • UNII 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 8470G57WFM
    Corn oil is a vegetable oil extracted from corn kernels. It's used in medicines as a solvent to dissolve active ingredients and help the body absorb them, and sometimes as a lubricant in capsules.
  • 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 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 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.

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

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

Inactive ingredient FAQ

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

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.076 $7.64 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.2075 $20.75 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.1822 $18.22 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.088 $0.075
▼ Down 1% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Benztropine Mesylate 1 mg 00904-7289-61 Major 100 tablets $0.076 AA Availability likely
Benztropine Mesylate 1 mg 11534-0168-09 SUNRISE 100 tablets $0.076 AA Availability likely
Benztropine Mesylate 1 mg 50228-0226-01 ScieGen 100 tablets $0.076 AA Availability likely
Benztropine Mesylate 1 mg 62135-0144-01 Chartwell 100 tablets $0.076 AA Availability likely
Benztropine Mesylate 1 mg 68084-0388-01 American 100 tablets $0.076 AA Availability likely
Benztropine Mesylate 1 mgthis 69315-0137-01 Leading 100 tablets $0.076 AA Availability likely
Benztropine Mesylate 1 mg 70752-0124-10 QUAGEN 100 tablets $0.076 AA Availability likely
Benztropine Mesylate 1 mg 00603-2434-10 Endo 10 tablets AA Discontinued
Benztropine Mesylate 1 mg 00615-8223-39 NCS 30 tablets AA Discontinued
Benztropine Mesylate 1 mg 10135-0814-01 Marlex 100 tablets AA FDA listed
Benztropine Mesylate 1 mg 50090-7017-00 A-S 100 tablets AA FDA listed
Benztropine Mesylate 1 mg 63187-0840-03 Proficient 3 tablets AA FDA listed
Benztropine Mesylate 1 mg 67046-0041-03 Coupler 30 tablets AA FDA listed
Benztropine Mesylate 1 mg 69097-0827-02 Cipla 30 tablets FDA listed
Benztropine Mesylate 1 mg 70518-0132-01 REMEDYREPACK 30 tablets FDA listed
Benztropine Mesylate 1 mg 70518-0577-00 REMEDYREPACK 30 tablets AA FDA listed
Benztropine Mesylate 1 mg 71610-0502-53 Aphena 60 tablets AA FDA listed
Benztropine Mesylate 1 mg 72162-2595-00 Bryant 1000 tablets AA FDA listed
Benztropine Mesylate 1 mg 87441-0012-01 Unit 30 tablets AA 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

🏛️
2012
On the market since
Nov 2012
📍
2026
Currently FDA-listed
14 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 69315-0137-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
146.9K
Units reimbursed last 4 qtrs
8.1M
Gross reimbursed last 4 qtrs
$1.69M
Avg / prescription
$11.49
Avg / unit
$0.2075
Latest quarter Q1 2026
29.2KRx
Medicaid pays / ea
$0.2075
gross reimbursed
vs
NADAC / ea
$0.0764
acquisition cost
=
Spread
+$0.1311
+172% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
45% FFS 55% MCO
Fee-for-service · 66,746 Rx Managed care · 80,112 Rx
State Medicaid map
Alaska: 6,729 units · 918 per 100k residents AK Maine: 30,280 units · 2,171 per 100k residents ME Washington: 101,549 units · 1,300 per 100k residents WA Idaho: 27,942 units · 1,423 per 100k residents ID Montana: 8,497 units · 751 per 100k residents MT North Dakota: 6,843 units · 874 per 100k residents ND Minnesota: 63,854 units · 1,113 per 100k residents MN Wisconsin: 107,257 units · 1,815 per 100k residents WI Michigan: 226,470 units · 2,256 per 100k residents MI New York: 890,296 units · 4,549 per 100k residents NY Vermont: 2,653 units · 410 per 100k residents VT New Hampshire: 12,668 units · 904 per 100k residents NH Oregon: 69,980 units · 1,653 per 100k residents OR Nevada: 70,507 units · 2,207 per 100k residents NV Wyoming: 5,183 units · 888 per 100k residents WY South Dakota: 5,050 units · 550 per 100k residents SD Iowa: 51,656 units · 1,611 per 100k residents IA Illinois: 218,769 units · 1,743 per 100k residents IL Indiana: 208,352 units · 3,036 per 100k residents IN Ohio: 422,716 units · 3,587 per 100k residents OH Pennsylvania: 444,000 units · 3,426 per 100k residents PA New Jersey: 290,480 units · 3,127 per 100k residents NJ Massachusetts: 340,759 units · 4,867 per 100k residents MA California: 668,849 units · 1,717 per 100k residents CA Utah: 50,578 units · 1,480 per 100k residents UT Colorado: 65,281 units · 1,111 per 100k residents CO Nebraska: 27,265 units · 1,378 per 100k residents NE Missouri: 124,463 units · 2,009 per 100k residents MO Kentucky: 142,616 units · 3,151 per 100k residents KY West Virginia: 84,598 units · 4,780 per 100k residents WV Virginia: 302,218 units · 3,467 per 100k residents VA Maryland: 298,051 units · 4,823 per 100k residents MD Connecticut: 135,423 units · 3,744 per 100k residents CT Rhode Island: 35,193 units · 3,214 per 100k residents RI Arizona: 181,436 units · 2,442 per 100k residents AZ New Mexico: 71,213 units · 3,369 per 100k residents NM Kansas: 28,008 units · 953 per 100k residents KS Arkansas: 85,283 units · 2,781 per 100k residents AR Tennessee: 108,293 units · 1,520 per 100k residents TN North Carolina: 273,291 units · 2,522 per 100k residents NC South Carolina: 184,026 units · 3,425 per 100k residents SC Delaware: 24,452 units · 2,372 per 100k residents DE Oklahoma: 85,822 units · 2,117 per 100k residents OK Louisiana: 89,451 units · 1,956 per 100k residents LA Mississippi: 68,966 units · 2,346 per 100k residents MS Alabama: 109,544 units · 2,145 per 100k residents AL Georgia: 252,154 units · 2,286 per 100k residents GA D.C.: 26,760 units · 3,941 per 100k residents DC Hawaii: 2,790 units · 194 per 100k residents HI Texas: 496,645 units · 1,628 per 100k residents TX Florida: 350,116 units · 1,549 per 100k residents FL
Units reimbursed · per 100k residents
1944,867
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Massachusetts 4,867 /100k
2 Maryland 4,823 /100k
3 West Virginia 4,780 /100k
4 New York 4,549 /100k
5 D.C. 3,941 /100k
6 Connecticut 3,744 /100k
7 Ohio 3,587 /100k
8 Virginia 3,467 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1000 tablets69315-0137-10 168,962 Rx · $1,958,994
100 tablets this page69315-0137-01 146,858 Rx · $1,686,913
Drug total (last 4 qtrs): 315,820 Rx · 16,236,096 units · $3,645,908 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 Benztropine Mesylate — the program that covers self-administered drugs. 12 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 Benztropine Mesylate. 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
$5.58M
Claims incl. refills
428.3K
Beneficiaries
171.1K
Spend / beneficiary
$32.60
Spend / claim
$13.03
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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Benztropine mesylate — the ingredient across all brands.

Top reported reactions

Granulocytopenia152
Completed Suicide132
Tremor126
Death125
Diabetes Mellitus120
Drug Interaction119
Weight Increased110

Age at onset

Neonate3
Child6
Adolescent2
Adult174
Elderly36

Reporter sex

2,659 reports
Male · 52%
Female · 48%
Unknown · 1%

Serious outcomes

Hospitalization898
Life-threatening121
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 146 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
69315-0137-01 You're viewing this 100 TABLET in 1 BOTTLE (69315-137-01) $0.0764 / ea $7.64 2016-05-15 Active
69315-0137-10 1000 TABLET in 1 BOTTLE (69315-137-10) $0.0764 / ea $76.37 2016-05-15 Active

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

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0764 NADAC).

This pack accounts for about 47% of this product's recent Medicaid fills; most go to the 1000 tablets pack. See all packs ↓

Pack size FAQ

What quantity is in NDC 69315-0137-01?
NDC 69315-0137-01 is a 100-count package — 100 tablet in 1 bottle.
What is the difference between NDC 69315-0137-01 and NDC 69315-0137-10?
Both are BENZTROPINE MESYLATE 1 mg Tablet — the drug itself is identical. NDC 69315-0137-01 is the 100-count package, while NDC 69315-0137-10 is the 1000 tablets package.
What NDC number is used to bill for this package of BENZTROPINE MESYLATE 1 mg Tablet?
Bill NDC 69315-0137-01 — the 11-digit billing format is 69315013701. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 43 words

INDICATIONS AND USAGE Benztropine mesylate tablets, USP are indicated for use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia - see PRECAUTIONS ) due to neuroleptic drugs (e.g., phenothiazines).

⏱️ Dosage and Administration ~3 min read

DOSAGE AND ADMINISTRATION Benztropine mesylate tablets should be used when patients are able to take oral medication. The injection is especially useful for psychotic patients with acute dystonic reactions or other reactions that make oral medication difficult or impossible. It is recommended also when a more rapid response is desired than can be obtained with the tablets.

Because of cumulative action, therapy should be initiated with a low dose which is increased gradually at five or six-day intervals to the smallest amount necessary for optimal relief. Increases should be made in increments of 0.5 mg, to a maximum of 6 mg, or until optimal results are obtained without excessive adverse reactions. Postencephalitic and Idiopathic Parkinsonism - The usual daily dose is 1 to 2 mg, with a range of 0.5 to 6 mg orally or parentally.

As with any agent used in parkinsonism, dosage must be individualized according to age and weight, and the type of parkinsonism being treated. Generally, older patients, and thin patients cannot tolerate large doses. Most patients with postencephalitic parkinsonism need fairly large doses and tolerate them well.

Patients with a poor mental outlook are usually poor candidates for therapy. In idiopathic parkinsonism, therapy may be initiated with a single daily dose of 0.5 to 1 mg at bedtime. In some patients, this will be adequate; in others 4 to 6 mg a day may be required.

In postencephalitic parkinsonism, therapy may be initiated in most patients with 2 mg a day in one or more doses. In highly sensitive patients, therapy may be initiated with 0.5 mg at bedtime, and increased as necessary. Some patients experience greatest relief by taking the entire dose at bedtime; others react more favorably to divided doses, two to four times a day.

Frequently, one dose a day is sufficient, and divided doses may be unnecessary or undesirable. The long duration of action of this drug makes it particularly suitable for bedtime medication when its effects may last throughout the night, enabling patients to turn in bed during the night more easily, and to rise in the morning. When benztropine mesylate is started, do not terminate therapy with other antiparkinsonian agents abruptly.

If the other agents are to be reduced or discontinued, it must be done gradually. Many patients obtain greatest relief with combination therapy. Benztropine mesylate may be used concomitantly with Carbidopa-Levodopa, or with levodopa, in which case periodic dosage adjustment may be required in order to maintain optimum response.

Drug-Induced Extrapyramidal Disorders - In treating extrapyramidal disorders due to neuroleptic drugs (e.g., phenothiazines), the recommended dosage is 1 to 4 mg once or twice a day orally, or parenterally. Dosage must be individualized according to the need of the patient. Some patients require more than recommended; others do not need as much.

In acute dystonic reactions, 1 to 2 mL of the injection usually relieves the condition quickly. After that, the tablets, 1 to 2 mg twice a day, usually prevents recurrence. When extrapyramidal disorders develop soon after initiation of treatment with neuroleptic drugs (e.g., phenothiazines), they are likely to be transient.

One to 2 mg of benztropine mesylate tablets two or three times a day usually provides relief within one or two days. After one or two weeks, the drug should be withdrawn to determine the continued need for it. If such disorders recur, benztropine mesylate can be reinstituted.

Certain drug-induced extrapyramidal disorders that develop slowly may not respond to benztropine mesylate. CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088 OR LEADING PHARMA, LLC AT 1-844-740-7500.

Contraindications 41 words

CONTRAINDICATIONS Hypersensitivity to benztropine mesylate tablets or to any component of the tablets. Because of its atropine-like side effects, this drug is contraindicated in pediatric patients under three years of age, and should be used with caution in older pediatric patients.

⚠️ Warnings 204 words

WARNINGS Safe use in pregnancy has not been established. Benztropine mesylate may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. When benztropine mesylate is given concomitantly with phenothiazines, haloperidol, or other drugs with anticholinergic or antidopaminergic activity, patients should be advised to report gastrointestinal complaints, fever or heat intolerance promptly.

Paralytic ileus, hyperthermia and heat stroke, all of which have sometimes been fatal, have occurred in patients taking anticholinergic-type antiparkinsonism drugs, including benztropine mesylate, in combination with phenothiazines and/or tricyclic antidepressants. Since benztropine mesylate contains structural features of atropine, it may produce anhidrosis. For this reason, it should be administered with caution during hot weather, especially when given concomitantly with other atropine-like drugs to the chronically ill, the alcoholic, those who have central nervous system disease, and those who do manual labor in a hot environment.

Anhidrosis may occur more readily when some disturbance of sweating already exists. If there is evidence of anhidrosis, the possibility of hyperthermia should be considered. Dosage should be decreased at the discretion of the physician so that the ability to maintain body heat equilibrium by perspiration is not impaired.

Severe anhidrosis and fatal hyperthermia have occurred.

🤒 Adverse Reactions 153 words

ADVERSE REACTIONS The adverse reactions below, most of which are antichlolinergic in nature, have been reported and within each category are listed in order of decreasing severity. Cardiovascular Tachycardia. Digestive Paralytic ileus, constipation, vomiting, nausea, dry mouth.

If dry mouth is so severe that there is difficulty in swallowing or speaking, or loss of appetite and weight, reduce dosage, or discontinue the drug temporarily. Slight reduction in dosage may control nausea and still give sufficient relief of symptoms. Vomiting may be controlled by temporary discontinuation, followed by resumption at a lower dosage.

Nervous System Toxic psychosis, including confusion, disorientation, memory impairment, visual hallucinations; exacerbation of preexisting psychotic symptoms; nervousness; depression; listlessness; numbness of fingers. Special Senses Blurred vision, dilated pupils. Urogenital Urinary retention, dysuria.

Metabolic/Immune or Skin Occasionally, an allergic reaction, e.g., skin rash, develops. If this cannot be controlled by dosage reduction, the medication should be discontinued. Other Heat stroke, hyperthermia, fever.

🔄 Drug Interactions 14 words

Drug Interactions Antipsychotic drugs such as phenothiazines or haloperidol; tricyclic antidepressants (see WARNINGS ).

🧒 Pediatric Use 26 words

Pediatric Use Because of the atropine-like side effects, benztropine mesylate should be used with caution in pediatric patients over three years of age (see CONTRAINDICATIONS ).

🆘 Overdosage 203 words

OVERDOSAGE Manifestations - May be any of those seen in atropine poisoning or antihistamine overdosage: CNS depression, preceded or followed by stimulation; confusion; nervousness; listlessness; intensification of mental symptoms or toxic psychosis in patients with mental illness being treated with neuroleptic drugs (e.g., phenothiazines); hallucinations (especially visual); dizziness; muscle weakness; ataxia; dry mouth; mydriasis; blurred vision; palpitations; tachycardia; elevated blood pressure; nausea; vomiting; dysuria; numbness of fingers; dysphagia; allergic reactions, e.g., skin rash; headache; hot, dry, flushed skin; delirium; coma; shock; convulsions; respiratory arrest; anhidrosis; hyperthermia; glaucoma; constipation.

Treatment - Physostigmine salicylate, 1 to 2 mg, SC or IV, reportedly will reverse symptoms of anticholinergic intoxication. * A second injection may be given after 2 hours if required. Otherwise treatment is symptomatic and supportive. Induce emesis or perform gastric lavage (contraindicated in precomatose convulsive, or psychotic states).

Maintain respiration. A short-acting barbiturate may be used for CNS excitement, but with caution to avoid subsequent depression; supportive care for depression (avoid convulsant stimulants such as picrotoxin, pentylenetetrazol, or bemegride); artificial respiration for severe respiratory depression; a local miotic for mydriasis and cycloplegia; ice bags or other cold applications and alcohol sponges for hyperpyrexia, a vasopressor and fluids for circulatory collapse. Darken room for photophobia.

🧬 Clinical Pharmacology 75 words

CLINICAL PHARMACOLOGY Benztropine mesylate possesses both anticholinergic and antihistaminic effects, although only the former have been established as therapeutically significant in the management of parkinsonism. In the isolated guinea pig ileum, the anticholinergic activity of this drug is about equal to that of atropine; however, when administered orally to unanesthetized cats, it is only about half as active as atropine. In laboratory animals, its antihistaminic activity and duration of action approach those of pyrilamine maleate.

📦 How Supplied / Storage and Handling 211 words

HOW SUPPLIED Benztropine Mesylate Tablets, USP, for oral use, are supplied in the following forms: As 0.5 mg: White color, round, flat face beveled edge, bisected, compressed tablets, debossed "EP” above the bisect and "136" below the bisect, on one side and plain on the other side, in bottles of 100 (NDC 69315-136-01), and 1000 (NDC 69315-136-10) tablets. As 1 mg: White color, oval, bisected, compressed tablets, debossed "EP" on the left side and "137" on the right side of the bisect, on one side and plain on the other side, in bottles of 100 (NDC 69315-137-01) and 1000 (NDC 69315-137-10) tablets.

As 2 mg: White color, round, flat face beveled edge, bisected, compressed tablets, debossed "EP" above bisect and "138" below bisect on one side and plain on the other side, in bottles of 100 (NDC 69315-138-01) and 1000 (NDC 69315-138-10) tablets. Store at 20° to 25° C (68° to 77°F); excursions permitted to 15° to 30° C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in well-closed containers as defined in the USP.

Keep out of reach of children. * Duvoisin, R.C.; Katz, R.J.; Amer. Med. Ass.

206:1963-1965, Nov. 25, 1968. Manufactured and Distributed by: Leading Pharma, LLC 3 Oak Road Fairfield, NJ 07004 USA Rev 04 12/20

📋 Description 100 words

DESCRIPTION Benztropine mesylate, USP is a synthetic compound containing structural features found in atropine and diphenhydramine. It is designated chemically as 3α-(Diphenylmethoxy) -1α-H,5 α H-tropane methanesulfonate. Its molecular formula is C 21 H 25 NO•CH 4 O 3 S, and its structural formula is: Benztropine mesylate, USP is a crystalline white powder, very soluble in water, and has a molecular weight of 403.54.

Each benztropine mesylate tablet, USP for oral administration contains benztropine mesylate 0.5 mg, 1 mg or 2 mg. Inactive ingredients: corn starch, dicalcium phosphate anhydrous, hydrogenated vegetable oil, lactose anhydrous, lactose monohydrate, microcrystalline cellulose, talc. Chemical structure

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.