SERTRALINE HYDROCHLORIDE
- Product NDC
- 55700-977
- 11-digit product format
- 557000977
- Labeler code
- 55700
- Product ID
- 55700-977_79158958-96ec-4c06-b689-329210805cc2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SERTRALINE HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Quality Care Products, LLC
- Application
- ANDA202825
- Marketing category
- ANDA
- Marketing start
- 2022-07-12
- Marketing end
- 0000-00-00
- Substance
- SERTRALINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 |
|---|
| 55700-977-90 | 55700097790 | 90 TABLET, FILM COATED in 1 BOTTLE (55700-977-90) | 2022-07-12 | 0000-00-00 | No | No | Current |