SERTRALINE HYDROCHLORIDE
- Product NDC
- 68788-8109
- 11-digit product format
- 687888109
- Labeler code
- 68788
- Product ID
- 68788-8109_fb0ae911-5304-408c-ad07-8eeb16bd45fa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SERTRALINE HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA202825
- Marketing category
- ANDA
- Marketing start
- 2021-12-03
- Marketing end
- 0000-00-00
- Substance
- SERTRALINE HYDROCHLORIDE
- Active strength
- 50 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
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8109 | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] | 4 | Legacy NDC | 20240809_74cc51d3-a9d0-404f-943a-575dc18dceb7.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-8109-1 | 68788810901 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-8109-1) | 2021-12-03 | 0000-00-00 | No | No | Current |
| 68788-8109-3 | 68788810903 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8109-3) | 2021-12-03 | 0000-00-00 | No | No | Current |
| 68788-8109-6 | 68788810906 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8109-6) | 2021-12-03 | 0000-00-00 | No | No | Current |
| 68788-8109-9 | 68788810909 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8109-9) | 2021-12-03 | 0000-00-00 | No | No | Current |