Fluoxetine
- Product NDC
- 16714-721
- 11-digit product format
- 167140721
- Labeler code
- 16714
- Product ID
- 16714-721_a7fb6b36-0508-4287-83c0-976f0f767265
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- NorthStar Rx LLC
- 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| I9W7N6B1KJ | FLUOXETINE HYDROCHLORIDE | 56296-78-7 | FLUOXETINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 16714-721-02 | 16714072102 | 100 CAPSULE in 1 BOTTLE (16714-721-02) | 100 capsule | 2008-01-31 | No | No | Historical |
| 16714-721-03 | 16714072103 | 1000 CAPSULE in 1 BOTTLE (16714-721-03) | 1000 capsule | 2008-01-31 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Fluoxetine | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 2024-05-20 | HUMAN PRESCRIPTION DRUG LABEL | 1 |
| Fluoxetine | NorthStar Rx LLC | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED | 2024-02-12 | Human Prescription Drug Label | 7 |
| Fluoxetine | A-S Medication Solutions | 2024-01-03 | Human Prescription Drug Label | 4 |
| Fluoxetine | A-S Medication Solutions | 2023-10-16 | Human Prescription Drug Label | 3 |