FLUOXETINE
- Product NDC
- 71335-2785
- 11-digit product format
- 713352785
- Labeler code
- 71335
- Product ID
- 71335-2785_f197b0ee-0e93-4639-9c5a-17cff936b036
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluoxetine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA212684
- Marketing category
- ANDA
- Marketing start
- 2024-08-12
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- FLUOXETINE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUOXETINE HYDROCHLORIDE | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | I9W7N6B1KJ |
| Rxcui | 248642 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-2785-1 | FLUOXETINE | 100 in 1 BOTTLE | TABLET | 100 | | 100 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2785-1 | 71335278501 | 100 TABLET in 1 BOTTLE (71335-2785-1) | 100 tablet | 2025-08-18 | No | No | Current |