Data / Drug companies / Benztropine mesylate
Benztropine mesylate: 22 companies and 53 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Benztropine mesylate is listed in the FDA National Drug Code Directory by 22 companies, with 53 products in commercial distribution. 53 of the products (100.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet; injection; injection, solution, and the newest product started marketing on June 8, 2026.
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- Companies listing it
- 22
- Products
- 53
- Generic (ANDA) products
- 53 (100.0%)
- Application numbers
- 11
- Routes
- Oral, Intramuscular, Intravenous
- openFDA record search
- api.fda.gov
Companies that list benztropine mesylate
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Coupler LLC | 5 | tablet | Generic drugs (ANDA) | May 26, 2026 |
| Bryant Ranch Prepack | 4 | tablet | Generic drugs (ANDA) | August 11, 2025 |
| Remedyrepack Inc. | 4 | tablet | Generic drugs (ANDA) | May 11, 2020 |
| American Health Packaging | 3 | tablet | Generic drugs (ANDA) | July 1, 2013 |
| Chartwell RX, LLC | 3 | tablet | Generic drugs (ANDA) | January 23, 1992 |
| Leading Pharma, LLC | 3 | tablet | Generic drugs (ANDA) | November 28, 2012 |
| Major Pharmaceuticals | 3 | tablet | Generic drugs (ANDA) | July 11, 2023 |
| Marlex Pharmaceuticals, Inc. | 3 | tablet | Generic drugs (ANDA) | March 1, 2025 |
| NCS HealthCare of Ky, LLC DBA Vangard Labs | 3 | tablet | Generic drugs (ANDA) | March 17, 2022 |
| Par Health USA, LLC | 3 | tablet | Generic drugs (ANDA) | March 17, 2022 |
| Quagen Pharmaceuticals LLC | 3 | tablet | Generic drugs (ANDA) | August 11, 2025 |
| ScieGen Pharmaceuticals, Inc. | 3 | tablet | Generic drugs (ANDA) | November 5, 2024 |
| Sunrise Pharmaceutical, Inc. | 3 | tablet | Generic drugs (ANDA) | October 16, 2024 |
| Hikma Pharmaceuticals USA Inc. | 2 | injection | Generic drugs (ANDA) | October 14, 2021 |
| A-S Medication Solutions | 1 | tablet | Generic drugs (ANDA) | March 17, 2022 |
| Aphena Pharma Solutions - Tennessee, LLC | 1 | tablet | Generic drugs (ANDA) | November 28, 2012 |
| Direct RX | 1 | tablet | Generic drugs (ANDA) | January 1, 2014 |
| Fresenius Kabi USA, LLC | 1 | injection, solution | Generic drugs (ANDA) | May 31, 2011 |
| Navinta LLC | 1 | injection | Generic drugs (ANDA) | November 24, 2020 |
| Proficient Rx LP | 1 | tablet | Generic drugs (ANDA) | November 28, 2012 |
| Unit Dose Solutions, Inc. | 1 | tablet | Generic drugs (ANDA) | June 8, 2026 |
| Zydus Pharmaceuticals USA Inc. | 1 | injection | Generic drugs (ANDA) | December 30, 2020 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet | 48 | 90.6% |
| Injection | 4 | 7.5% |
| Injection, solution | 1 | 1.9% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 53 | 100% |
Pharmacologic classes
| Class | Products |
|---|---|
| Anticholinergic | 53 |
| Antihistamine | 53 |
CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.