Fluoxetine
- Product NDC
- 50090-6081
- 11-digit product format
- 500906081
- Labeler code
- 50090
- Product ID
- 50090-6081_107069a9-db7c-4635-93f8-3d56fdf0399c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA078619
- Marketing category
- ANDA
- Marketing start
- 2008-01-31
- 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 | 310385 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50090-6081-0 | 50090608100 | 30 CAPSULE in 1 BOTTLE (50090-6081-0) | 30 capsule | 2022-09-20 | 0000-00-00 | No | No | Current |
| 50090-6081-1 | 50090608101 | 60 CAPSULE in 1 BOTTLE (50090-6081-1) | 60 capsule | 2022-09-20 | 0000-00-00 | No | No | Current |
| 50090-6081-3 | 50090608103 | 90 CAPSULE in 1 BOTTLE (50090-6081-3) | 90 capsule | 2022-09-20 | 0000-00-00 | No | No | Current |