SERTRALINE HYDROCHLORIDE
- Product NDC
- 53002-4215
- 11-digit product format
- 530024215
- Labeler code
- 53002
- Product ID
- 53002-4215_dfc0f5e1-2242-41bc-ad38-a36c424b4043
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SERTRALINE HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA202825
- Marketing category
- ANDA
- Marketing start
- 2017-02-09
- 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| UTI8907Y6X | SERTRALINE HYDROCHLORIDE | 79559-97-0 | SERTRALINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53002-4215-0 | 53002421500 | 100 TABLET, FILM COATED in 1 BOTTLE (53002-4215-0) | 2021-01-01 | 0000-00-00 | No | No | Current |
| 53002-4215-3 | 53002421503 | 30 TABLET, FILM COATED in 1 BOTTLE (53002-4215-3) | 2021-01-01 | 0000-00-00 | No | No | Current |
| 53002-4215-6 | 53002421506 | 60 TABLET, FILM COATED in 1 BOTTLE (53002-4215-6) | 2021-01-01 | 0000-00-00 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| SERTRALINE HYDROCHLORIDE | RPK Pharmaceuticals, Inc. | 2022-03-30 | HUMAN PRESCRIPTION DRUG LABEL | 1 |