Fluoxetine
- Product NDC
- 50090-7914
- 11-digit product format
- 500907914
- Labeler code
- 50090
- Product ID
- 50090-7914_15a88e56-20f2-49f8-96b5-56567af7922c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA078619
- Marketing category
- ANDA
- Marketing start
- 2025-09-01
- 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
- 2027-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| I9W7N6B1KJ | FLUOXETINE HYDROCHLORIDE | 56296-78-7 | FLUOXETINE HYDROCHLORIDE |
| 01K63SUP8D | FLUOXETINE | 54910-89-3 | Fluoxetine |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-7914-0 | 50090791400 | 30 CAPSULE in 1 BOTTLE (50090-7914-0) | 30 capsule | 2026-02-23 | No | No | Historical |
| 50090-7914-1 | 50090791401 | 90 CAPSULE in 1 BOTTLE (50090-7914-1) | 90 capsule | 2026-02-23 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Fluoxetine | A-S Medication Solutions | 2026-03-03 | Human Prescription Drug Label | 1 |