Fluoxetine
- Product NDC
- 68071-2375
- 11-digit product format
- 680712375
- Labeler code
- 68071
- Product ID
- 68071-2375_29a539bb-42ee-dc73-e063-6394a90a5fe9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA204597
- Marketing category
- ANDA
- Marketing start
- 2015-03-16
- 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 |
|---|
| 68071-2375-3 | 68071237503 | 30 CAPSULE in 1 BOTTLE (68071-2375-3) | 30 capsule | 2021-03-24 | No | No | Historical |
| 68071-2375-9 | 68071237509 | 90 CAPSULE in 1 BOTTLE (68071-2375-9) | 90 capsule | 2024-12-19 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Fluoxetine | NuCare Pharmaceuticals,Inc. | 2024-12-19 | HUMAN PRESCRIPTION DRUG LABEL | 2 |