Drug
Who makes fluoxetine hcl?
2 companies list fluoxetine hcl as a human prescription drug. Forms: capsule; tablet. 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 hcl
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Direct RxUnited States | capsule | ANDAANDA204597 | 2 | 1 |
| Strides Pharma Science LimitedIndia | tablet | ANDAANDA212683 | 1 | 5 |
Bulk ingredient listings
- Kalchem International Inc.United States · 1 NDC
- Siegfried USA, LLCUnited States · 1 NDC
- Teva API India Private Ltd.India · 1 NDC
Enquiry
Common questions
- Who makes fluoxetine hcl?
- 2 companies list fluoxetine hcl as a human prescription drug in the openFDA NDC Directory, led by Direct Rx, Strides Pharma Science 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 fluoxetine hcl?
- 2 companies list fluoxetine hcl under an abbreviated new drug application (ANDA), the application type used for generics. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies fluoxetine hcl active ingredient?
- 3 companies list fluoxetine hcl as a bulk ingredient, including Kalchem International Inc., Siegfried USA, LLC, Teva API India Private Ltd..