Drug
Who makes fluoxetine hydrochloride?
42 companies list fluoxetine hydrochloride as a human prescription drug, including under the names Prozac. Forms: capsule; capsule, delayed release pellets; for solution; liquid; solution; tablet; tablet, coated; tablet, film coated. 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 fluoxetine hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Bryant Ranch PrepackUnited States | capsule; tablet, coated | ANDAANDA078619, ANDA203836, ANDA204597 | 17 | 1 |
| International Medication Systems, Ltd.United States | capsule | ANDAANDA078619, ANDA204597 | 15 | 3 |
| Proficient Rx LPUnited States | capsule | ANDAANDA078619, ANDA204597 | 8 | 1 |
| Northwind Health Company, LLCUnited States | capsule | ANDAANDA075465, ANDA078619, ANDA204597 | 6 | 1 |
| ScieGen Pharmaceuticals India Private LimitedIndia | capsule; tablet | ANDAANDA204597, ANDA211282 | 5 | 3 |
| NuCare Pharmaceuticals,Inc.United States | capsule | ANDAANDA078619, ANDA204597 | 5 | 1 |
| RemedyRepack, IncUnited States | capsule | ANDAANDA078619, ANDA204597 | 5 | 1 |
| PD-Rx Pharmaceuticals Inc.United States | capsule | ANDAANDA078619, ANDA204597 | 4 | 1 |
| Northstar Rx, LLC, | capsule; tablet, film coated | ANDAANDA078619, ANDA211721 | 4 | 0 |
| Lupin LimitedIndia | tablet | ANDAANDA211632, ANDA211653 | 3 | 14 |
| MARKSANS PHARMA LIMITEDIndia | capsule | ANDAANDA075465 | 3 | 2 |
| Preferred Pharmaceuticals Inc.United States | capsule | ANDAANDA204597 | 3 | 1 |
| Radha Pharmaceuticals, Inc.United States | capsule | ANDAANDA204597 | 3 | 1 |
| Time Cap Laboratories, Inc.United States | capsule | ANDAANDA075465 | 3 | 1 |
| Aphena Pharma Solutions - Tennessee, LLC | capsule | ANDAANDA204597 | 3 | 0 |
| BluePoint Laboratories Inc. | capsule | ANDAANDA078619 | 3 | 0 |
| Dista Products Company | capsule | NDANDA018936 | 3 | 0 |
| Quallent Pharmaceuticals Health, LLC | capsule | ANDAANDA078619 | 3 | 0 |
| Vensun Pharmaceuticals, Inc. | capsule | ANDAANDA204597 | 3 | 0 |
| Dr. Reddy's Laboratories LimitedIndia | capsule, delayed release pellets; tablet, film coated | ANDAANDA078572, ANDA211721 | 2 | 15 |
| Alembic Pharmaceuticals LimitedIndia | tablet, film coated | ANDAANDA208698 | 2 | 7 |
| Par Health USA, LLCIndia | tablet, coated | ANDAANDA203836 | 2 | 5 |
| Calvin Scott & Co., Inc.United States | capsule | ANDAANDA204597 | 2 | 1 |
| Coupler LLCUnited States | capsule | ANDAANDA204597 | 2 | 1 |
| PAI Holdings, LLCUnited States | solution | ANDAANDA076015 | 2 | 1 |
| MAJOR Pharmaceuticals Inc. | capsule | ANDAANDA078619 | 2 | 0 |
| Cardinal Health 418, Inc.United States | capsule | ANDAANDA078619 | 1 | 34 |
| Sun Pharmaceutical Industries LimitedIndia | tablet, film coated | ANDAANDA211477 | 1 | 13 |
| Aurobindo Pharma LimitedIndia | capsule | ANDAANDA078619 | 1 | 6 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | capsule | ANDAANDA078619 | 1 | 5 |
| Nivagen Pharmaceuticals LLCUnited States | tablet | ANDAANDA209695 | 1 | 2 |
| ANI Pharmaceuticals, Inc.United States | solution | ANDAANDA216448 | 1 | 1 |
| Boswell Pharmacy Services LLCUnited States | capsule | ANDAANDA078619 | 1 | 1 |
| Direct RxUnited States | capsule | ANDAANDA078619 | 1 | 1 |
| Lannett Company, LLCUnited States | liquid | ANDAANDA077849 | 1 | 1 |
| MedSource LabsUnited States | capsule | ANDAANDA204597 | 1 | 1 |
| NCS HealthCare of KY, LLC dba Vangard LabsUnited States | capsule | ANDAANDA078619 | 1 | 1 |
| QPharma IncUnited States | capsule | ANDAANDA078619 | 1 | 1 |
| RedPharm DrugUnited States | capsule | ANDAANDA204597 | 1 | 1 |
| St. Mary's Medical Park PharmacyUnited States | capsule | ANDAANDA204597 | 1 | 1 |
| CouplerLLC | capsule | ANDAANDA078619 | 1 | 0 |
| Upsher-Smith Laboratories, Inc. | for solution | ANDAANDA216953 | 1 | 0 |
Bulk ingredient listings
- Olon USA LLCItaly · 2 NDC
- Alembic Pharmaceuticals LimitedIndia · 1 NDC
- Assia Chemical Industries Ltd. - Teva Tech SiteIsrael · 1 NDC
- Aurobindo Pharma LimitedIndia · 1 NDC
- Bajaj Healthcare LtdIndia · 1 NDC
- Cadila Pharmaceuticals LimitedIndia · 1 NDC
- Chemeca Drugs Private LimitedIndia · 1 NDC
- Dr. Reddys Laboratories Limited · 1 NDC
- Erregierre SpAItaly · 1 NDC
- LETCO MEDICAL, LLCUnited States · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- QUIMICA SINTETICA SASpain · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
- XENEX LABORATORIES INCCanada · 1 NDC
Enquiry
Common questions
- Who makes fluoxetine hydrochloride?
- 42 companies list fluoxetine hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Bryant Ranch Prepack, International Medication Systems, Ltd., Proficient Rx LP, Northwind Health Company, LLC, ScieGen Pharmaceuticals India Private Limited. 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 Prozac?
- 41 companies list fluoxetine 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 fluoxetine hydrochloride active ingredient?
- 15 companies list fluoxetine hydrochloride as a bulk ingredient, including Olon USA LLC, Alembic Pharmaceuticals Limited, Assia Chemical Industries Ltd. - Teva Tech Site, Aurobindo Pharma Limited.