Fluoxetine
- Product NDC
- 68071-3130
- 11-digit product format
- 680713130
- Labeler code
- 68071
- Product ID
- 68071-3130_4b6b2ce1-e317-3921-e054-00144ff8d46c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA204597
- Marketing category
- ANDA
- Marketing start
- 2015-03-16
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record