Fluoxetine
- Product NDC
- 67046-1580
- 11-digit product format
- 670461580
- Labeler code
- 67046
- Product ID
- 67046-1580_3e111b48-7c02-ee3b-e063-6394a90a5499
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- CouplerLLC
- Application
- ANDA078619
- Marketing category
- ANDA
- Marketing start
- 2025-09-05
- Substance
- FLUOXETINE HYDROCHLORIDE
- Active strength
- 40 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| I9W7N6B1KJ | FLUOXETINE HYDROCHLORIDE | 56296-78-7 | FLUOXETINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 67046-1580-3 | 67046158003 | 30 CAPSULE in 1 BLISTER PACK (67046-1580-3) | 30 capsule | 2025-09-05 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Fluoxetine | CouplerLLC | Coupler LLC | 2025-09-05 | HUMAN PRESCRIPTION DRUG LABEL | 1 |