SERTRALINE HYDROCHLORIDE
- Product NDC
- 68071-3379
- 11-digit product format
- 680713379
- Labeler code
- 68071
- Product ID
- 68071-3379_540d3033-12cd-5f8a-e054-00144ff8d46c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SERTRALINE HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA202825
- Marketing category
- ANDA
- Marketing start
- 2017-02-09
- Marketing end
- 0000-00-00
- Substance
- SERTRALINE HYDROCHLORIDE
- Active strength
- 100 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