Fluoxetine
- Product NDC
- 50090-2589
- 11-digit product format
- 500902589
- Labeler code
- 50090
- Product ID
- 50090-2589_2343e8ec-e077-483b-a010-ff8bcc1d0a99
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA078619
- Marketing category
- ANDA
- Marketing start
- 2008-01-31
- 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 |
|---|
| 50090-2589-0 | 50090258900 | 30 CAPSULE in 1 BOTTLE (50090-2589-0) | 30 capsule | 2017-02-01 | No | No | Historical |
| 50090-2589-1 | 50090258901 | 90 CAPSULE in 1 BOTTLE (50090-2589-1) | 90 capsule | 2016-11-02 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Fluoxetine | A-S Medication Solutions | 2024-10-09 | Human Prescription Drug Label | 25 |