Sertraline
- Product NDC
- 0615-7991
- 11-digit product format
- 006157991
- Labeler code
- 0615
- Product ID
- 0615-7991_2622f272-25ec-440d-b04b-649b3720175c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA077670
- Marketing category
- ANDA
- Marketing start
- 2007-02-06
- Marketing end
- 0000-00-00
- Substance
- SERTRALINE HYDROCHLORIDE
- Active strength
- 100 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 | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0615-7991-05 | 00615799105 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-7991-05) | | 2016-04-07 | 0000-00-00 | No | No | Current |
| 0615-7991-30 | 00615799130 | 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-7991-30) > 5 TABLET, FILM COATED in 1 BLISTER PACK | 6 blister pack | 2016-04-07 | 0000-00-00 | No | No | Current |
| 0615-7991-39 | 00615799139 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7991-39) | | 2016-04-07 | 0000-00-00 | No | No | Current |