Fluoxetine
- Product NDC
- 0378-0734
- 11-digit product format
- 003780734
- Labeler code
- 0378
- Product ID
- 0378-0734_e4caca4f-07a8-4686-b5f2-5b14070fe413
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluoxetine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA075755
- Marketing category
- ANDA
- Marketing start
- 2013-12-23
- Marketing end
- 0000-00-00
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-0734-01 | 00378073401 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0734-01) | 2013-12-23 | 0000-00-00 | No | No | Current |
| 0378-0734-93 | 00378073493 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0734-93) | 2013-12-23 | 0000-00-00 | No | No | Current |