Fluoxetine
- Product NDC
- 71335-2778
- 11-digit product format
- 713352778
- Labeler code
- 71335
- Product ID
- 71335-2778_b1fb7c4e-9fa8-4fc1-8dae-315e211c5d8f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA213286
- Marketing category
- ANDA
- Marketing start
- 2020-04-08
- 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
openFDA Listing Details
- Product ID
- 71335-2778_b1fb7c4e-9fa8-4fc1-8dae-315e211c5d8f
- SPL ID
- b1fb7c4e-9fa8-4fc1-8dae-315e211c5d8f
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Fluoxetine
- Generic name
- Fluoxetine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing start
- 2020-04-08
- Marketing category
- ANDA
- Application number
- ANDA213286
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC]; Serotonin Uptake Inhibitors [MoA]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| FLUOXETINE HYDROCHLORIDE | 10 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | I9W7N6B1KJ |
| Rxcui | 313990 |
| Spl Set Id | c1c7ec04-dd9e-400f-8f49-e900945fc61c |
| Manufacturer Name | Bryant Ranch Prepack |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71335-2778-1 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2778-1) | 2025-10-13 | No |
| 71335-2778-2 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-2778-2) | 2025-10-13 | No |
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 |
|---|
| 71335-2778-1 | 71335277801 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2778-1) | 2025-10-13 | No | No | Historical |
| 71335-2778-2 | 71335277802 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-2778-2) | 2025-10-13 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Fluoxetine | Bryant Ranch Prepack | 2025-10-13 | HUMAN PRESCRIPTION DRUG LABEL | 1 |