SERTRALINE HYDROCHLORIDE
- Product NDC
- 43602-463
- 11-digit product format
- 436020463
- Labeler code
- 43602
- Product ID
- 43602-463_43908d66-b866-4556-bd54-2696fb58037c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sertraline hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Ascent Pharmaceuticals, Inc
- Application
- ANDA214790
- Marketing category
- ANDA
- Marketing start
- 2021-05-03
- 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43602-463 | SERTRALINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [ASCENT PHARMACEUTICALS, INC] | 2 | Legacy NDC | 20210508_5f6674af-8a24-4ea3-867e-7fafe6e7d578.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43602-463-05 | 43602046305 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43602-463-05) | 2021-05-03 | 0000-00-00 | No | No | Current |
| 43602-463-30 | 43602046330 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43602-463-30) | 2021-05-03 | 0000-00-00 | No | No | Current |