Fluoxetine
- Product NDC
- 0904-7195
- 11-digit product format
- 009047195
- Labeler code
- 0904
- Product ID
- 0904-7195_5b30a7b2-2587-451f-9906-9b7abb7c4ccc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA079209
- Marketing category
- ANDA
- Marketing start
- 2009-03-19
- Marketing end
- 0000-00-00
- Substance
- FLUOXETINE HYDROCHLORIDE
- Active strength
- 20 mg/5mL
- 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 |
|---|
| 0904-7195 | FLUOXETINE SOLUTION [MAJOR PHARMACEUTICALS] | 2 | Legacy NDC | 20240727_5b30a7b2-2587-451f-9906-9b7abb7c4ccc.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0904-7195-94 | 00904719594 | 40 CUP, UNIT-DOSE in 1 CASE (0904-7195-94) > 5 mL in 1 CUP, UNIT-DOSE (0904-7195-41) | 2022-12-19 | 0000-00-00 | No | No | Current |