Fluoxetine
- Product NDC
- 50090-7225
- 11-digit product format
- 500907225
- Labeler code
- 50090
- Product ID
- 50090-7225_4046e69b-99c5-4e6a-88d5-65a47af87326
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA204597
- Marketing category
- ANDA
- Marketing start
- 2015-03-16
- Substance
- FLUOXETINE HYDROCHLORIDE
- Active strength
- 20 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 |
|---|
| 50090-7225-0 | 50090722500 | 30 CAPSULE in 1 BOTTLE (50090-7225-0) | 30 capsule | 2024-08-20 | No | No | Historical |
| 50090-7225-1 | 50090722501 | 60 CAPSULE in 1 BOTTLE (50090-7225-1) | 60 capsule | 2024-08-20 | No | No | Historical |
| 50090-7225-3 | 50090722503 | 90 CAPSULE in 1 BOTTLE (50090-7225-3) | 90 capsule | 2024-08-20 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Fluoxetine | A-S Medication Solutions | 2025-10-18 | HUMAN PRESCRIPTION DRUG LABEL | 8 |
| Fluoxetine | A-S Medication Solutions | 2024-08-22 | HUMAN PRESCRIPTION DRUG LABEL | 6 |