# Fluoxetine by Coupler LLC: new human prescription drug listing

**Launch Signal Score:** 65/100

| Field | Value |
|---|---|
| Product | Fluoxetine |
| Generic name | Fluoxetine |
| NDC | 67046-1695 |
| Labeler | Coupler LLC |
| Product type | HUMAN PRESCRIPTION DRUG |
| Approval pathway | ANDA |
| Application number | ANDA078619 |
| Dosage form | CAPSULE |
| Route | ORAL |
| Active ingredients | FLUOXETINE HYDROCHLORIDE 10 mg/1 |
| Marketing start | 2026-10-02 |
| Package configurations | 1 |

## Why this score
- Prescription or biologic product.
- New generic entry: wholesalers and GPOs re-bid contracts.

Source: U.S. FDA National Drug Code (NDC) Directory via openFDA (https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=67046-1695). Last refreshed: 2026-11-03T18:09:00.764Z.
Listing data comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn. Informational only; not medical advice.