Fluoxetine
- Product NDC
- 70518-4428
- 11-digit product format
- 705184428
- Labeler code
- 70518
- Product ID
- 70518-4428_3bb88af7-5af2-8a09-e063-6294a90a61cf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA213286
- Marketing category
- ANDA
- Marketing start
- 2025-08-06
- 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4428-0 | 70518442800 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4428-0) | 2025-08-06 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Fluoxetine | REMEDYREPACK INC. | 2025-08-06 | HUMAN PRESCRIPTION DRUG LABEL | 1 |