FLUOXETINE
- Product NDC
- 71656-089
- 11-digit product format
- 716560089
- Labeler code
- 71656
- Product ID
- 71656-089_38420669-08b4-a3e4-e063-6294a90a4573
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FLUOXETINE
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Saptalis Pharmaceuticals, LLC.
- Application
- ANDA075525
- Marketing category
- ANDA
- Marketing start
- 2025-06-20
- Substance
- FLUOXETINE HYDROCHLORIDE
- Active strength
- 20 mg/5mL
- 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/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | I9W7N6B1KJ |
| Rxcui | 310386 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71656-089-04 | FLUOXETINE | 120 mL in 1 BOTTLE | SOLUTION | 120 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71656-089-04 | 71656008904 | 120 mL in 1 BOTTLE (71656-089-04) | 120 ml | 2025-06-20 | No | No | Current |