Fluoxetine
- Product NDC
- 50090-7232
- 11-digit product format
- 500907232
- Labeler code
- 50090
- Product ID
- 50090-7232_19fd63e7-d4bf-46c7-b13e-9cab103447b9
- 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 |
|---|
| 50090-7232-0 | 50090723200 | 90 CAPSULE in 1 BOTTLE (50090-7232-0) | 90 capsule | 2024-08-26 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Fluoxetine | A-S Medication Solutions | 2024-09-18 | Human Prescription Drug Label | 18 |