Drug
Who makes donepezil hydrochloride?
31 companies list donepezil hydrochloride as a human prescription drug, including under the names Aricept. Forms: tablet; tablet, film coated; tablet, orally disintegrating. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing donepezil hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Bryant Ranch PrepackUnited States | tablet; tablet, film coated | ANDAANDA078662, ANDA090056, ANDA200292 | 12 | 1 |
| Macleods Pharmaceuticals LimitedIndia | tablet, film coated; tablet, orally disintegrating | ANDAANDA201146, ANDA201787, ANDA202631 | 5 | 5 |
| Alembic Pharmaceuticals LimitedIndia | tablet, film coated | ANDAANDA201724 | 4 | 7 |
| Unichem Laboratories Limited, IndiaIndia | tablet, film coated; tablet, orally disintegrating | ANDAANDA203656, ANDA204831 | 4 | 5 |
| International Medication Systems, Ltd.United States | tablet; tablet, film coated | ANDAANDA090056, ANDA200292, ANDA201146 | 4 | 3 |
| Solco healthcare U.S., LLC | tablet, film coated | ANDAANDA200292 | 4 | 0 |
| Eisai Inc.United States | tablet, film coated | NDANDA020690, NDA022568 | 3 | 6 |
| Golden State Medical Supply Inc.United States | tablet, film coated | ANDAANDA203104, ANDA203907 | 3 | 1 |
| RemedyRepack, IncUnited States | tablet; tablet, film coated | ANDAANDA090056, ANDA200292, ANDA203034 | 3 | 1 |
| Cardinal Health 418, Inc.United States | tablet, film coated | ANDAANDA090686 | 2 | 34 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet | ANDAANDA203034 | 2 | 5 |
| Torrent Pharma, Inc.India | tablet, film coated | ANDAANDA090686 | 2 | 5 |
| Cadila Pharmaceuticals LimitedIndia | tablet, film coated | ANDAANDA204609 | 2 | 3 |
| ScieGen Pharmaceuticals India Private LimitedIndia | tablet, film coated | ANDAANDA203907 | 2 | 3 |
| ACI Healthcare USA, Inc.United States | tablet | ANDAANDA078662 | 2 | 2 |
| ASCLEMED USA INC. DBA ENOVACHEMUnited States | tablet, film coated | ANDAANDA200292 | 2 | 1 |
| Camber Pharmaceuticals, Inc.United States | tablet | ANDAANDA203034 | 2 | 1 |
| NCS HealthCare of KY, LLC dba Vangard LabsUnited States | tablet, film coated | ANDAANDA201146 | 2 | 1 |
| Preferred Pharmaceuticals Inc.United States | tablet; tablet, film coated | ANDAANDA078662, ANDA090056 | 2 | 1 |
| Rising Pharma Holdings, Inc.United States | tablet, film coated | ANDAANDA090056 | 2 | 1 |
| MAJOR Pharmaceuticals Inc. | tablet, film coated | ANDAANDA090686 | 2 | 0 |
| Quallent Pharmaceuticals Health, LLC | tablet | ANDAANDA203034 | 2 | 0 |
| Lupin LimitedIndia | tablet | ANDAANDA202782 | 1 | 14 |
| Sun Pharmaceutical Industries LimitedIndia | tablet, film coated | ANDAANDA204293 | 1 | 13 |
| Coupler LLCUnited States | tablet, film coated | ANDAANDA090056 | 1 | 1 |
| Direct RxUnited States | tablet, film coated | ANDAANDA200292 | 1 | 1 |
| Proficient Rx LPUnited States | tablet, film coated | ANDAANDA203104 | 1 | 1 |
| DirectRx | tablet, film coated | ANDAANDA200292 | 1 | 0 |
| Dr. Reddys Laboratories Limited | tablet, film coated | ANDAANDA202723 | 1 | 0 |
| Edenbridge Pharmaceuticals LLC. | tablet, film coated | ANDAANDA203713 | 1 | 0 |
| Upsher-Smith Laboratories, Inc. | tablet, film coated | ANDAANDA203104 | 1 | 0 |
Bulk ingredient listings
- USV Private LimitedIndia · 2 NDC
- Aurobindo Pharma LimitedIndia · 1 NDC
- CIPLA PHARMACEUTICALS LIMITEDIndia · 1 NDC
- Curia India Private LimitedItaly · 1 NDC
- Neuland Laboratories LimitedIndia · 1 NDC
- SYNTHIMED LABS PRIVATE LIMITEDIndia · 1 NDC
- Sun Pharmaceutical Industries LimitedIndia · 1 NDC
- Unichem Laboratories Limited, IndiaIndia · 1 NDC
- Zhejiang Hisun Pharmaceutical Co., Ltd.China · 1 NDC
- Zhejiang Huahai Pharmaceutical Technology Co LtdChina · 1 NDC
- Zydus Lifesciences LimitedIndia · 1 NDC
Orange Book patents
12 unexpired patents list donepezil hydrochloride as the active ingredient, expiring between Oct 2026 and Aug 2038. Application holders: CORIUM LLC, EISAI INC.
Enquiry
Common questions
- Who makes donepezil hydrochloride?
- 31 companies list donepezil hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Bryant Ranch Prepack, Macleods Pharmaceuticals Limited, Alembic Pharmaceuticals Limited, Unichem Laboratories Limited, India, International Medication Systems, Ltd.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Aricept?
- 30 companies list donepezil hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies donepezil hydrochloride active ingredient?
- 11 companies list donepezil hydrochloride as a bulk ingredient, including USV Private Limited, Aurobindo Pharma Limited, CIPLA PHARMACEUTICALS LIMITED, Curia India Private Limited.