Medicine
Benztropine 0.5 mg tablet
Benztropine 0.5 mg tablet is a generic prescription medicine for oral use, made by 14 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Benztropine
- Brand
- Sold under the generic name
- Strength
- 0.5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets, 100 tablets, 1000 tablets and 25 more
- Manufacturers
- CiplaIndiaBryant Ranch PrepackRemedyrepackChartwell RXCouplerLeading PharmaMarlex PharmaceuticalsPar HealthQuagen PharmaceuticalsScieGen Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N04AC01 Benztropine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 23 January 1992
- Identifiers
- RxCUI 885209, 885213, 885219DailyMed set ID c19664aa-a797-4192-b5f3-e906a7cac048, 241479dd-91bf-455a-80a1-1bb2d1c8156d, df0647b8-2aa7-4aa4-9ba3-82c28698e7c5 +12NDC 0603-2433, 70518-2732, 0615-8222 +12Application ANDA040715, ANDA090168, ANDA204713 +4
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 tablet in 1 bottle | 69097-826-02 | CiplaIndia | 29 June 2016 |
| 100 tablet in 1 bottle | 69097-826-07 | CiplaIndia | 29 June 2016 |
| 1000 tablet in 1 bottle | 69097-826-15 | CiplaIndia | 29 June 2016 |
| 180 tablet in 1 bottle | 62135-141-18 | Chartwell RX | 1 September 2022 |
| 540 tablet in 1 bottle | 62135-141-57 | Chartwell RX | 1 September 2022 |
| 100 tablet in 1 bottle | 69315-136-01 | Leading Pharma | 15 May 2016 |
| 1000 tablet in 1 bottle | 69315-136-10 | Leading Pharma | 15 May 2016 |
| 100 tablet in 1 bottle, plastic | 0603-2433-21 | Par Health | 17 March 2022 |
| 1000 tablet in 1 bottle, plastic | 0603-2433-32 | Par Health | 17 March 2022 |
| 100 tablet in 1 bottle, plastic | 70752-123-10 | Quagen Pharmaceuticals | 11 August 2025 |
| 1000 tablet in 1 bottle, plastic | 70752-123-11 | Quagen Pharmaceuticals | 11 August 2025 |
| 100 tablet in 1 bottle | 50228-225-01 | ScieGen Pharmaceuticals | 5 November 2024 |
| 1000 tablet in 1 bottle | 50228-225-10 | ScieGen Pharmaceuticals | 5 November 2024 |
| 100 tablet in 1 bottle | 11534-167-09 | Sunrise Pharmaceutical | 16 October 2024 |
| 1000 tablet in 1 bottle | 11534-167-10 | Sunrise Pharmaceutical | 16 October 2024 |
| 30 tablet in 1 blister pack | 67046-1205-3 | Coupler | 6 May 2026 |
| 30 tablet in 1 blister pack | 67046-1674-3 | Coupler | 1 May 2026 |
| 100 blister pack in 1 box, unit-dose / 1 tablet in 1 blister pack | 68084-381-01 | American Health Packaging | 9 November 2009 |
| 1000 tablet in 1 bottle | 72162-2594-0 | Bryant Ranch Prepack | 7 January 2026 |
| 100 tablet in 1 bottle | 72162-2594-1 | Bryant Ranch Prepack | 7 January 2026 |
| 100 tablet in 1 bottle | 72162-2594-2 | Bryant Ranch Prepack | 7 January 2026 |
| 100 blister pack in 1 carton / 1 tablet in 1 blister pack | 0904-7288-61 | Major Pharmaceuticals | 11 July 2023 |
| 100 tablet in 1 bottle | 10135-813-01 | Marlex PHARMACEUTICAL | 1 March 2025 |
| 1000 tablet in 1 bottle | 10135-813-10 | Marlex PHARMACEUTICAL | 1 March 2025 |
| 30 tablet in 1 blister pack | 70518-2732-0 | Remedyrepack | 11 May 2020 |
| 100 pouch in 1 box / 1 tablet in 1 pouch | 70518-2732-4 | Remedyrepack | 5 January 2026 |
| 100 pouch in 1 box / 1 tablet in 1 pouch | 70518-2732-5 | Remedyrepack | 29 April 2026 |
| 30 tablet in 1 blister pack | 0615-8222-39 | Vangard Labs | 6 June 2023 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 5 March 1954 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Benztropine
Clinical summary
Benztropine is an anticholinergic. It is available as tablets and injection for oral, intramuscular and intravenous use. MedsAcross supplies Benztropine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about BenztropineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Benztropine Mesylate prescribing information (Par Health) · U.S. National Library of Medicine, DailyMed
Need Benztropine 0.5 mg tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.