Medicine
Benztropine 2 mg/2 mL injection
Benztropine 2 mg/2 mL injection is a generic prescription medicine for intramuscular, intravenous use, made by 4 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 25°C (77°F), excursions permitted to 15º to 30°C (59º to 86°F).
Key facts
- Active ingredient (INN)
- Benztropine
- Brand
- Sold under the generic name
- Strength
- 2 mg/2 mL
- Dosage form
- Injection
- Route
- Intramuscular, intravenous
- Packs
- 5 vials of 2 mL, 5 ampules of 2 mL and 2 more
- Manufacturers
- Zydus LifesciencesIndiaHikma PharmaceuticalsFresenius KabiNavinta
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15º to 30°C (59º to 86°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
- 1 September 2009
- Identifiers
- RxCUI 885205DailyMed set ID 95620f40-5ddf-41b8-80a5-f658248f26f0, b03bd28e-3b44-41e4-9a7e-28b9d7975245, ecaeaadf-0847-4605-a205-a674f75f8bb2 +2NDC 0143-9729, 63323-970, 68382-860 +2Application ANDA090287, ANDA090233, ANDA091525 +1
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 |
|---|---|---|---|
| 5 vial in 1 carton / 2 mL in 1 vial | 68382-860-10 | Zydus LifesciencesIndia | 30 December 2020 |
| 5 vial in 1 box / 2 mL in 1 vial | 0143-9233-05 | Hikma Pharmaceuticals | 14 October 2021 |
| 5 ampule in 1 carton / 2 mL in 1 ampule | 0143-9729-05 | Hikma Pharmaceuticals | 1 September 2009 |
| 5 vial in 1 box / 2 mL in 1 vial | 63323-970-02 | Fresenius Kabi | 31 May 2011 |
| 5 vial in 1 carton / 2 mL in 1 vial | 68475-512-02 | Navinta | 24 November 2020 |
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 2 mg/2 mL injection 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.