Drug
Who makes paroxetine hydrochloride?
14 companies list paroxetine hydrochloride as a human prescription drug, including under the names PAXIL, PAXIL CR. Forms: suspension; tablet, film coated; tablet, film coated, extended release. 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 paroxetine hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Apotex Inc.Canada | tablet, film coated; tablet, film coated, extended release | ANDA, NDA, NDA AUTHORIZED GENERICANDA075356, NDA020031, NDA020936 | 14 | 6 |
| Zydus Lifesciences LimitedIndia | tablet, film coated | ANDAANDA077584 | 4 | 12 |
| Golden State Medical Supply Inc.United States | tablet, film coated | ANDAANDA075356 | 4 | 1 |
| Oxford Pharmaceuticals, LLCUnited States | tablet, film coated | ANDAANDA076968 | 4 | 1 |
| Northstar Rx, LLC, | tablet, film coated | ANDAANDA078406 | 4 | 0 |
| Lannett Company, LLCUnited States | tablet, film coated, extended release | ANDAANDA204744 | 3 | 1 |
| RemedyRepack, IncUnited States | tablet, film coated | ANDAANDA075356 | 3 | 1 |
| Aphena Pharma Solutions - Tennessee, LLC | tablet, film coated | ANDAANDA075356 | 3 | 0 |
| Bryant Ranch PrepackUnited States | tablet, film coated; tablet, film coated, extended release | ANDAANDA076968, ANDA204744 | 2 | 1 |
| Preferred Pharmaceuticals Inc.United States | tablet, film coated | ANDAANDA077584 | 2 | 1 |
| MAJOR Pharmaceuticals Inc. | tablet, film coated | ANDAANDA075356 | 2 | 0 |
| Cardinal Health 418, Inc.United States | tablet, film coated | ANDAANDA075356 | 1 | 34 |
| Aurobindo Pharma LimitedIndia | tablet, film coated | ANDAANDA078406 | 1 | 6 |
| Camber Pharmaceuticals, Inc.United States | suspension | ANDAANDA219954 | 1 | 1 |
Bulk ingredient listings
- Ningbo Vitax Biotech Co LtdChina · 1 NDC
- ThermoFisher Scientific Cork · 1 NDC
Enquiry
Common questions
- Who makes paroxetine hydrochloride?
- 14 companies list paroxetine hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Apotex Inc., Zydus Lifesciences Limited, Golden State Medical Supply Inc., Oxford Pharmaceuticals, LLC, Northstar Rx, 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 PAXIL?
- 14 companies list paroxetine 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 paroxetine hydrochloride active ingredient?
- 2 companies list paroxetine hydrochloride as a bulk ingredient, including Ningbo Vitax Biotech Co Ltd, ThermoFisher Scientific Cork.