Fluoxetine
- Product NDC
- 80425-0313
- 11-digit product format
- 804250313
- Labeler code
- 80425
- Product ID
- 80425-0313_2a9bf7d3-46d9-0dfa-e063-6394a90a76a4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA204597
- Marketing category
- ANDA
- Marketing start
- 2023-04-11
- Substance
- FLUOXETINE HYDROCHLORIDE
- Active strength
- 20 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 |
| 01K63SUP8D | FLUOXETINE | 54910-89-3 | Fluoxetine |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0313-1 | 80425031301 | 30 CAPSULE in 1 BOTTLE (80425-0313-1) | 30 capsule | 2023-04-11 | No | No | Historical |
| 80425-0313-2 | 80425031302 | 60 CAPSULE in 1 BOTTLE (80425-0313-2) | 60 capsule | 2023-04-11 | No | No | Historical |
| 80425-0313-3 | 80425031303 | 90 CAPSULE in 1 BOTTLE (80425-0313-3) | 90 capsule | 2023-04-11 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Fluoxetine Capsules | Advanced Rx Pharmacy of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL | 2 |