Drug
Who makes doxepin hydrochloride?
41 companies list doxepin hydrochloride as a human prescription drug, including under the names PRUDOXIN, Silenor, Zonalon. Forms: capsule; cream; solution; tablet. Routes: oral, topical.
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 doxepin hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Bryant Ranch PrepackUnited States | capsule; tablet | ANDAANDA070791, ANDA202510, ANDA207482 | 18 | 1 |
| RemedyRepack, IncUnited States | capsule; tablet | ANDAANDA071669, ANDA202510, ANDA211618 | 12 | 1 |
| Alembic Pharmaceuticals LimitedIndia | capsule | ANDAANDA215076 | 10 | 7 |
| Mylan Pharmaceuticals, Inc. | capsule; cream | ANDA, NDA, NDA AUTHORIZED GENERICANDA070791, NDA020126 | 8 | 0 |
| Novadoz Pharmaceuticals LLC | capsule; tablet | ANDAANDA214823, ANDA215113 | 7 | 0 |
| Leading Pharma, LLCUnited States | capsule | ANDAANDA211618, ANDA211619 | 6 | 1 |
| Aurobindo Pharma LimitedIndia | capsule | ANDAANDA211603 | 5 | 6 |
| Epic Laboratories, LLCUnited States | capsule | ANDAANDA210675 | 5 | 3 |
| Ajanta Pharma LimitedIndia | capsule | ANDAANDA212624 | 5 | 2 |
| Amneal Ireland LimitedIreland | capsule | ANDAANDA207482 | 5 | 1 |
| Contract Pharmacal Corp.United States | capsule | ANDAANDA213474 | 5 | 1 |
| Florida Pharmaceutical Products LLCUnited States | capsule | ANDAANDA213474 | 5 | 1 |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.United States | capsule | ANDAANDA214908 | 5 | 1 |
| PD-Rx Pharmaceuticals Inc.United States | capsule | ANDAANDA070791, ANDA211603, ANDA213474 | 5 | 1 |
| Proficient Rx LPUnited States | capsule | ANDAANDA211603, ANDA212624, ANDA215113 | 5 | 1 |
| Rising Pharma Holdings, Inc.United States | capsule | ANDAANDA217975 | 5 | 1 |
| Chartwell RX, LLC. | capsule | ANDAANDA210268 | 5 | 0 |
| First Nation Group, LLC | capsule | ANDAANDA215710 | 5 | 0 |
| Lifestar Pharma LLC. | capsule | ANDAANDA215710 | 5 | 0 |
| NorthStar RxLLC | capsule | ANDAANDA215710 | 5 | 0 |
| PuraCap Laboratories LLC dba Blu Pharmaceuticals | capsule | ANDAANDA210675 | 5 | 0 |
| International Medication Systems, Ltd.United States | capsule | ANDAANDA207482, ANDA213063, ANDA215076 | 4 | 3 |
| Safecor Health, LLCUnited States | capsule | ANDAANDA070791 | 4 | 3 |
| APPCO PHARMA LLCUnited States | capsule | ANDAANDA214908 | 4 | 1 |
| Golden State Medical Supply Inc.United States | tablet | ANDAANDA214823, ANDA219058 | 4 | 1 |
| Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven | tablet | NDA, NDA AUTHORIZED GENERICNDA022036 | 4 | 0 |
| MAJOR Pharmaceuticals Inc. | capsule | ANDAANDA207482 | 4 | 0 |
| Mylan Institutional Inc. | capsule | ANDAANDA070791 | 4 | 0 |
| Sun Pharmaceutical Industries LimitedIndia | tablet | ANDAANDA219058 | 2 | 13 |
| Strides Pharma Science LimitedIndia | tablet | ANDAANDA202510 | 2 | 5 |
| Boswell Pharmacy Services LLCUnited States | capsule | ANDAANDA215076, ANDA215710 | 2 | 1 |
| Coupler LLCUnited States | capsule | ANDAANDA212624 | 2 | 1 |
| Aphena Pharma Solutions - Tennessee, LLC | capsule | ANDAANDA070791 | 2 | 0 |
| Teva Pharmaceutical Industries Ltd.Canada | cream | ANDAANDA215408 | 1 | 6 |
| ADVANCED RX PHARMACY OF TENNESSEE LLCUnited States | capsule | ANDAANDA213063 | 1 | 1 |
| Direct RxUnited States | capsule | ANDAANDA213063 | 1 | 1 |
| Lannett Company, LLCUnited States | solution | ANDAANDA074721 | 1 | 1 |
| NuCare Pharmaceuticals,Inc.United States | capsule | ANDAANDA211603 | 1 | 1 |
| RedPharm DrugUnited States | capsule | ANDAANDA207482 | 1 | 1 |
| Advanced Rx of Tennessee, LLC | capsule | ANDAANDA215076 | 1 | 0 |
| Amneal Pharmaceuticals NY LLC | cream | ANDAANDA212357 | 1 | 0 |
Bulk ingredient listings
- Professional Compounding Centers of America dba PCCAUnited States · 2 NDC
- Dipharma Francis SrlItaly · 1 NDC
- LETCO MEDICAL, LLCUnited States · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- MSN Life Sciences Private LimitedIndia · 1 NDC
- Olon USA LLCItaly · 1 NDC
- R.L.Fine Chem Private LimitedIndia · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
Orange Book patents
16 unexpired patents list doxepin hydrochloride as the active ingredient, expiring between May 2027 and Sept 2030. Application holder: CURRAX PHARMACEUTICALS LLC.
Enquiry
Common questions
- Who makes doxepin hydrochloride?
- 41 companies list doxepin hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Bryant Ranch Prepack, RemedyRepack, Inc, Alembic Pharmaceuticals Limited, Mylan Pharmaceuticals, Inc., Novadoz Pharmaceuticals LLC. 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 PRUDOXIN?
- 40 companies list doxepin hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies doxepin hydrochloride active ingredient?
- 8 companies list doxepin hydrochloride as a bulk ingredient, including Professional Compounding Centers of America dba PCCA, Dipharma Francis Srl, LETCO MEDICAL, LLC, MEDISCA Inc..