Fluoxetine
- Product NDC
- 71205-974
- 11-digit product format
- 712050974
- Labeler code
- 71205
- Product ID
- 71205-974_14464dfb-94a5-43a1-923e-d462b7ade131
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA204597
- Marketing category
- ANDA
- Marketing start
- 2019-09-25
- Substance
- FLUOXETINE HYDROCHLORIDE
- Active strength
- 10 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 |
|---|
| 71205-974-00 | 71205097400 | 100 CAPSULE in 1 BOTTLE (71205-974-00) | 100 capsule | 2020-05-07 | No | No | Historical |
| 71205-974-11 | 71205097411 | 1000 CAPSULE in 1 BOTTLE (71205-974-11) | 1000 capsule | 2020-05-07 | No | No | Historical |
| 71205-974-30 | 71205097430 | 30 CAPSULE in 1 BOTTLE (71205-974-30) | 30 capsule | 2020-05-07 | No | No | Historical |
| 71205-974-55 | 71205097455 | 500 CAPSULE in 1 BOTTLE (71205-974-55) | 500 capsule | 2020-05-07 | No | No | Historical |
| 71205-974-60 | 71205097460 | 60 CAPSULE in 1 BOTTLE (71205-974-60) | 60 capsule | 2020-05-07 | No | No | Historical |
| 71205-974-72 | 71205097472 | 120 CAPSULE in 1 BOTTLE (71205-974-72) | 120 capsule | 2020-05-07 | No | No | Historical |
| 71205-974-90 | 71205097490 | 90 CAPSULE in 1 BOTTLE (71205-974-90) | 90 capsule | 2020-05-07 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Fluoxetine | Proficient Rx LP | 2022-03-01 | HUMAN PRESCRIPTION DRUG LABEL | 3 |