Fluoxetine
- Product NDC
- 50090-6066
- 11-digit product format
- 500906066
- Labeler code
- 50090
- Product ID
- 50090-6066_9853c9a4-1176-4ff0-b03e-19f2924fd093
- 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
- Marketing end
- 0000-00-00
- Substance
- FLUOXETINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 | Marketing end | Sample | Exclude flag | Status |
|---|
| 50090-6066-0 | 50090606600 | 1 BLISTER PACK in 1 CARTON (50090-6066-0) > 32 CAPSULE in 1 BLISTER PACK | 1 blister pack | 2022-09-09 | 0000-00-00 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Fluoxetine | A-S Medication Solutions | 2022-09-15 | Human Prescription Drug Label | 1 |