Fluoxetine
- Product NDC
- 63629-5930
- 11-digit product format
- 636295930
- Labeler code
- 63629
- Product ID
- 63629-5930_4b756a64-ce57-4db2-b70f-681d542a1133
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA208698
- Marketing category
- ANDA
- Marketing start
- 2017-04-07
- Substance
- FLUOXETINE HYDROCHLORIDE
- Active strength
- 10 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 |
|---|
| 63629-5930-1 | 63629593001 | 30 TABLET, FILM COATED in 1 BOTTLE (63629-5930-1) | 2025-06-02 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Fluoxetine | Bryant Ranch Prepack | 2025-06-02 | HUMAN PRESCRIPTION DRUG LABEL | 1 |