duloxetine
- Product NDC
- 68788-6427
- 11-digit product format
- 687886427
- Labeler code
- 68788
- Product ID
- 68788-6427_5a4f6cfe-3b6b-49ba-aace-225daef55662
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- duloxetine
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA202336
- Marketing category
- ANDA
- Marketing start
- 2016-06-21
- Marketing end
- 0000-00-00
- Substance
- DULOXETINE HYDROCHLORIDE
- Active strength
- 30 mg/1
- Pharmacologic classes
- Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record