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Benztropine Mesylate 1 mg/mL Injection — NDC 68475-0512-02 package photo

Benztropine Mesylate 1 mg/mL Injection

by Navinta LLC · 5 VIAL in 1 CARTON (68475-512-02) / 2 mL in 1 VIAL (68475-512-01)
NDC 68475-0512-02
🏷️ FDA NDC (as labeled) 68475-512-02 billing pads the product segment with a zero
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 →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 68475-512-02
Product NDC 68475-512
11-digit billing NDC 68475051202
RxCUI 885205
UNII WMJ8TL7510
UPC 0368475512016
Application # ANDA091525
SPL Set ID f92fbafa-314d-4449-831f-26108339e6b2
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 2020-11-24
Route INTRAMUSCULAR, INTRAVENOUS
Dosage form INJECTION
Substance BENZTROPINE MESYLATE
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 68475-512-02 — 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 → 68475-0512-02. 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

LabelerNavinta LLC
Application holderNAVINTA LLC
FDA applicationANDA091525 (ANDA)
Labeler code68475
First marketedNov 2020
Product typeHuman Prescription Drug
Portfolio20 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

📗 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 →

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.

🧪 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 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

2 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.

💲 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
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.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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/mL 00143-9233-05 Hikma 5 vials — AP FDA listed —
Benztropine Mesylate 1 mg/mL 00143-9729-05 Hikma 5 ampules — AP FDA listed —
Benztropine Mesylate 1 mg/mL 63323-0970-02 Fresenius 5 vials — AP FDA listed —
Benztropine Mesylate 1 mg/mL 68382-0860-10 Zydus 5 vials — AP FDA listed —
Benztropine Mesylate 1 mg/mLthis 68475-0512-02 Navinta 5 vials — AP 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

🏛️
2020
On the market since
Nov 2020
📍
2026
Currently FDA-listed
6 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.

📊 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 Marketing startStatus
68475-0512-02 You're viewing this 5 VIAL in 1 CARTON (68475-512-02) / 2 mL in 1 VIAL (68475-512-01) 2020-11-24 Active

🧭 About this NDC listing & data coverage

Finished prescription product
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 ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
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

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
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 FDA registers it as 68475-512-02, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 68475-0512-02, written without dashes as 68475051202. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 68475-0512-02, the first segment (68475) is the labeler code FDA assigned to Navinta LLC; the middle segment (0512) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Navinta LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Navinta LLC 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.

📄 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 ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 40 words ▾

INDICATIONS For use as an adjunct in the therapy of all forms of parkinsonism (see DOSAGE AND ADMINISTRATION ). 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 Since there is no significant difference in onset of effect after intravenous or intramuscular injection, usually there is no need to use the intravenous route. The drug is quickly effective after either route, with improvement sometimes noticeable a few minutes after injection. In emergency situations, when the condition of the patient is alarming, 1 to 2 mL of the injection normally will provide quick relief.

If the parkinsonian effect begins to return, the dose can be repeated. 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 following dosing guidelines were written in reference to both benztropine mesylate tablets and Benztropine mesylate injection. Benztropine mesylate tablets should be used when patients are able to take oral medication. The usual daily dose is 1 to 2 mg, with a range of 0.5 to 6 mg parenterally.

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 when given 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 injection, USP 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 injection, USP may be used concomitantly with SINEMET (Ccarbidopa-Levodopalevodopa), or with levodopa, in which case 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 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. 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 injection, USP two or three times a day usually provides relief within one or two days.

If such disorders recur, Benztropine mesylate injection, USP can be reinstituted. Certain drug-induced extrapyramidal disorders that develop slowly may not respond to Benztropine mesylate injection, USP.

⛔ Contraindications 38 words ▾

CONTRAINDICATIONS Hypersensitivity to any component of Benztropine mesylate injection, USP. 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 212 words ▾

WARNINGS Safe use in pregnancy has not been established. Benztropine mesylate injection, USP 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 injection, USP 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 injection, USP in combination with phenothiazines and/or tricyclic antidepressants. Since Benztropine mesylate injection, USP 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 171 words ▾

ADVERSE REACTIONS The adverse reactions below, most of which are anticholinergic 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 pre-existing 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.

To report SUSPECTED ADVERSE REACTIONS, contact Navinta LLC (USA) at +1-(609)-883-1135 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🆘 Overdosage 199 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. 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. **Duvoisin, R.C.; Katz, R.J.; Amer. Med.

Ass. 206 :1963-1965, Nov. 25, 1968.

🧬 Clinical Pharmacology 76 words ▾

ACTIONS Benztropine mesylate injection, USP 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 52 words ▾

HOW SUPPLIED Benztropine mesylate injection, USP, 2 mg per 2 mL (1 mg/mL), is a clear, colorless solution and is supplied as follows:- (NDC 68475-512-01) 2 mL vial (NDC 68475-512-02) Carton of 5 X 2 mL vials Recommended Storage: Store at 20° to 25°C (68 to 77°F). [See USP controlled room temperature].

📋 Description 98 words ▾

DESCRIPTION Benztropine mesylate is a synthetic compound containing structural features found in atropine and diphenhydramine. It is designated chemically as 8-azabicyclo[3.2.1] octane, 3-(diphenylmethoxy)-, endo , methanesulfonate. Its empirical formula is C 21 H 25 NO•CH 4 O 3 S, and its structural formula is: Benztropine mesylate is a crystalline white powder, very soluble in water, and has a molecular weight of 403.54.

Benztropine mesylate injection, USP is supplied as a sterile injection for intravenous and intramuscular use. Each milliliter of the injection contains: Benztropine mesylate USP----------------------------------------------------------------------------------1 mg Sodium chloride USP----------------------------------------------------------------------------------------9 mg Water for injection USP q.s.--------------------------------------------------------------------------------1 mL benztropine-fig-01

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 68475-0510-01 · Navinta 68475-0513-01 · Navinta →
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.