Fluoxetine
- Product NDC
- 70518-1757
- 11-digit product format
- 705181757
- Labeler code
- 70518
- Product ID
- 70518-1757_7e8094ed-784c-6f53-e053-2a91aa0af7c7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluoxetine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA075755
- Marketing category
- ANDA
- Marketing start
- 2019-01-01
- 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