SERTRALINE HYDROCHLORIDE
- Product NDC
- 68788-7928
- 11-digit product format
- 687887928
- Labeler code
- 68788
- Product ID
- 68788-7928_951770de-b51e-4bdf-9256-b07285474217
- 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
- 2021-06-14
- 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
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-7928 | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] | 4 | Legacy NDC | 20240809_721ad591-efe0-4617-ad58-a1070a7eb65a.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-7928-1 | 68788792801 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-7928-1) | 2021-06-14 | 0000-00-00 | No | No | Current |
| 68788-7928-3 | 68788792803 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-7928-3) | 2021-06-14 | 0000-00-00 | No | No | Current |
| 68788-7928-6 | 68788792806 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-7928-6) | 2021-06-14 | 0000-00-00 | No | No | Current |
| 68788-7928-9 | 68788792809 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-7928-9) | 2021-06-14 | 0000-00-00 | No | No | Current |