Prescription medicine
Benztropine First approved as Cogentin
Benztropine (Cogentin) is a prescription medicine with an FDA approval on record since 1954. FDA's NDC Directory lists it from 23 generic labelers, and pharmacies paid $0.0753 per benztropine mes 1 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- A presentation discontinued
Check it at the source: the benztropine FDA label on DailyMed (effective January 9, 2026, ScieGen Pharmaceuticals Inc); the NDA 9193 record on Drugs@FDA; every benztropine label on DailyMed.
Highlights of the record
FDA label of January 9, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageBenztropine mesylate tablets are indicated for use as an adjunct in the therapy of all forms of parkinsonism.
Forms and strengths
- 0.5 mg
- 1 mg
- 2 mg
- 1 mg/ml
Tablet; injection; injection (solution).
On the market
- Earliest approval on file
- March 5, 1954 Cogentin, Merck; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 22 first April 11, 1985; 16 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 23 of which 23 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0753 per tablet Benztropine mes 1 mg tablet
- Shortage (FDA)
- None current 1 past records
- Recalls by its makers (FDA)
- 3 since 2013 0 Class I among all firms' recalls; latest March 15, 2021
- FAERS reports
- 7,287 through July 30, 2026
What is benztropine used for?
From the label: indications and usageBenztropine mesylate tablets 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).
Conditions named in the indications of benztropine's FDA labels, with every medicine labeled for each:
From other benztropine labelsParkinson's disease: INDICATIONS AND USAGE Benztropine mesylate tablets are indicated for use as an adjunct in the therapy of all forms of parkinsonism.
FDA pharmacologic class: Anticholinergic and Antihistamine.
Source: FDA drug label (Benztropine Mesylate), ScieGen Pharmaceuticals Inc, effective January 9, 2026 (SPL set 1ead16a7-88ed-407d-b25a-0d9a1d9da5ef), via openFDA; the full label on DailyMed
Is there a generic for benztropine (Cogentin)?
The FDA approved the first generic benztropine on April 11, 1985. 22 generic applications are approved; 16 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists benztropine from 23 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1954 earliest approval on file
- 1985 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for benztropine (Cogentin)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0753 per Benztropine mes 1 mg tablet, down 4% from $0.0781 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Benztropine mes 1 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Benztropine mes 0.5 mg tablet | Generic | $0.0647 per tablet | $1.94 | -11% |
| Benztropine mes 1 mg tablet | Generic | $0.0753 per tablet | $2.26 | -4% |
| Benztropine mes 2 mg tablet | Generic | $0.0906 per tablet | $2.72 | -8% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is benztropine in shortage?
No benztropine presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 1 record is all marked to be discontinued, the latest updated January 27, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Benztropine Mesylate, Injection, 1 mg/1 mL (NDC 63323-970-02) | Fresenius Kabi USA, LLC | To Be Discontinued | January 27, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has benztropine been recalled?
The FDA's Enforcement Report lists 3 recalls naming benztropine since 2013: 0 Class I (the most serious), 3 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| August 1, 2013 | Class II | Nexus Pharmaceuticals Inc | Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination. |
| July 1, 2013 | Class II | Fresenius Kabi USA, LLC | Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination observed in reserve … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the benztropine label say about other medicines?
The benztropine label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 4 other medicines name benztropine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Atropine | warnings | Since benztropine mesylate contains structural features of atropine, it may produce anhidrosis. |
| Haloperidol | drug interactions | Drug Interactions Antipsychotic drugs such as phenothiazines or haloperidol; tricyclic antidepressants (see WARNINGS ). |
Other labels that name benztropine
Source: FDA drug label (Benztropine Mesylate), ScieGen Pharmaceuticals Inc, effective January 9, 2026 (SPL set 1ead16a7-88ed-407d-b25a-0d9a1d9da5ef), via openFDA; the full label on DailyMed
What do FAERS reports show for benztropine?
The FDA Adverse Event Reporting System holds 7,287 reports that list benztropine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,347 are coded as a death and 2,706 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as benztropine?
13 other medicines are given the same way (oral) and in the same FDA class as benztropine or labeled mainly for the same use (parkinson's disease), the same class first. Parkinson's disease lists all 19 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Ropinirole | Parkinson's disease | 27 labelers | $0.046 per tablet 0.25 mg tablet | No current entry |
| Pramipexole | Parkinson's disease | 22 labelers | $0.0452 per tablet 0.25 mg tablet | No current entry |
| Carbidopa and levodopa | Parkinson's disease | 33 labelers | $0.0759 per tablet 25-100 tablet | No current entry |
| Rasagiline | Parkinson's disease | 14 labelers | $0.521 per tablet 0.5 mg tablet | No current entry |
| Carbidopa and entacapone and levodopa | Parkinson's disease | 4 labelers | $0.695 per tablet 25-100-200 mg tablet | No current entry |
| Trihexyphenidyl | Parkinson's disease | 8 labelers | $0.0884 per tablet 2 mg tablet | No current entry |
| Entacapone | Parkinson's disease | 11 labelers | $0.325 per tablet 200 mg tablet | No current entry |
| Selegiline | Parkinson's disease | 11 labelers | $0.756 per capsule 5 mg capsule | No current entry |
Every medicine labeled for the same conditions as benztropine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does benztropine compare with medicines for the same use?
3 side-by-side pages set benztropine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to benztropine
- 13 medicines for the same use
- Other anticholinergics
- the pharmacologic class, with prices and generics
- Benztropine side effects
- the label's list beside FAERS reports
- Benztropine shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other