SERTRALINE HYDROCHLORIDE
- Product NDC
- 70518-1615
- 11-digit product format
- 705181615
- Labeler code
- 70518
- Product ID
- 70518-1615_f15fc1ed-dfff-eb62-e053-2995a90ac7a9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SERTRALINE HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA202825
- Marketing category
- ANDA
- Marketing start
- 2018-10-30
- 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
- 2024-12-31
- 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 |
|---|
| 70518-1615-0 | 70518161500 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1615-0) | 2018-10-30 | 0000-00-00 | No | No | Current |
| 70518-1615-1 | 70518161501 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1615-1) | 2023-01-03 | 0000-00-00 | No | No | Current |