Fluoxetine
- Product NDC
- 50090-7914
- 11-digit product format
- 500907914
- Labeler code
- 50090
- Product ID
- 50090-7914_15a88e56-20f2-49f8-96b5-56567af7922c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA078619
- Marketing category
- ANDA
- Marketing start
- 2025-09-01
- Substance
- FLUOXETINE HYDROCHLORIDE
- Active strength
- 40 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fluoxetine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUOXETINE HYDROCHLORIDE | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | I9W7N6B1KJ |
| Rxcui | 313989 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-7914-0 | Fluoxetine | 30 in 1 BOTTLE | CAPSULE | 30 | | 1 |
| 50090-7914-1 | Fluoxetine | 90 in 1 BOTTLE | CAPSULE | 90 | | 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 |
|---|
| 50090-7914-0 | 50090791400 | 30 CAPSULE in 1 BOTTLE (50090-7914-0) | 30 capsule | 2026-02-23 | No | No | Current |
| 50090-7914-1 | 50090791401 | 90 CAPSULE in 1 BOTTLE (50090-7914-1) | 90 capsule | 2026-02-23 | No | No | Current |