Sertraline Hydrochloride
- Product NDC
- 68382-044
- 11-digit product format
- 683820044
- Labeler code
- 68382
- Product ID
- 68382-044_b6253c4c-9752-4a05-a051-cdff7f914089
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals (USA) Inc.
- Application
- ANDA077106
- Marketing category
- ANDA
- Marketing start
- 2017-12-02
- Marketing end
- 0000-00-00
- Substance
- SERTRALINE HYDROCHLORIDE
- Active strength
- 50 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
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68382-044-01 | 68382004401 | 100 TABLET, FILM COATED in 1 BOTTLE (68382-044-01) | 2017-12-02 | 0000-00-00 | No | No | Current |
| 68382-044-05 | 68382004405 | 500 TABLET, FILM COATED in 1 BOTTLE (68382-044-05) | 2017-12-02 | 0000-00-00 | No | No | Current |
| 68382-044-06 | 68382004406 | 30 TABLET, FILM COATED in 1 BOTTLE (68382-044-06) | 2017-12-02 | 0000-00-00 | No | No | Current |
| 68382-044-10 | 68382004410 | 1000 TABLET, FILM COATED in 1 BOTTLE (68382-044-10) | 2017-12-02 | 0000-00-00 | No | No | Current |
| 68382-044-14 | 68382004414 | 60 TABLET, FILM COATED in 1 BOTTLE (68382-044-14) | 2017-12-02 | 0000-00-00 | No | No | Current |
| 68382-044-16 | 68382004416 | 90 TABLET, FILM COATED in 1 BOTTLE (68382-044-16) | 2017-12-02 | 0000-00-00 | No | No | Current |