Fluoxetine
- Product NDC
- 60687-659
- 11-digit product format
- 606870659
- Labeler code
- 60687
- Product ID
- 60687-659_235a6eb9-d960-13f0-e063-6394a90a5e8b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA078619
- Marketing category
- ANDA
- Marketing start
- 2022-07-21
- 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 |
|---|
| 60687-659-01 | 60687065901 | 100 BLISTER PACK in 1 CARTON (60687-659-01) / 1 CAPSULE in 1 BLISTER PACK (60687-659-11) | 100 blister pack | 2022-07-21 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Fluoxetine | American Health Packaging | 2024-09-30 | HUMAN PRESCRIPTION DRUG LABEL | 3 |