Fluoxetine
- Product NDC
- 50090-6702
- 11-digit product format
- 500906702
- Labeler code
- 50090
- Product ID
- 50090-6702_57eb3004-f630-4418-a421-c235024c74b3
- 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
- 2019-09-25
- 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
- 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 |
|---|
| 50090-6702-0 | 50090670200 | 30 CAPSULE in 1 BOTTLE (50090-6702-0) | 30 capsule | 2023-09-25 | No | No | Historical |
| 50090-6702-2 | 50090670202 | 90 CAPSULE in 1 BOTTLE (50090-6702-2) | 90 capsule | 2023-09-25 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Fluoxetine | A-S Medication Solutions | 2023-10-01 | HUMAN PRESCRIPTION DRUG LABEL | 1 |