Fluoxetine
- Product NDC
- 60687-845
- 11-digit product format
- 606870845
- Labeler code
- 60687
- Product ID
- 60687-845_31f54f70-b632-cb9e-e063-6394a90a329f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA079209
- Marketing category
- ANDA
- Marketing start
- 2024-12-04
- Substance
- FLUOXETINE HYDROCHLORIDE
- Active strength
- 20 mg/5mL
- 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 |
| 01K63SUP8D | FLUOXETINE | 54910-89-3 | Fluoxetine |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 60687-845-77 | 60687084577 | 4 TRAY in 1 CASE (60687-845-77) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-845-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-845-40) | 4 tray | 2024-12-04 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Fluoxetine | American Health Packaging | 2025-04-04 | HUMAN PRESCRIPTION DRUG LABEL | 3 |