Fluoxetine
- Product NDC
- 42291-398
- 11-digit product format
- 422910398
- Labeler code
- 42291
- Product ID
- 42291-398_ec6b074f-015f-7eac-e053-2a95a90a8bc5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA075452
- Marketing category
- ANDA
- Marketing start
- 2017-08-14
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42291-398 | FLUOXETINE CAPSULE [AVKARE] | 6 | Legacy NDC | 20240110_2a6581fc-d458-4bb3-97fa-2179405599ca.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42291-398-01 | 42291039801 | 100 CAPSULE in 1 BOTTLE (42291-398-01) | 100 capsule | 2017-08-14 | 0000-00-00 | No | No | Current |
| 42291-398-50 | 42291039850 | 500 CAPSULE in 1 BOTTLE (42291-398-50) | 500 capsule | 2017-08-14 | 0000-00-00 | No | No | Current |