Sertraline Hydrochloride
- Product NDC
- 70518-4307
- 11-digit product format
- 705184307
- Labeler code
- 70518
- Product ID
- 70518-4307_361ee404-9599-0df9-e063-6294a90a14ae
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA077397
- Marketing category
- ANDA
- Marketing start
- 2025-03-11
- 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
- 2026-12-31
- Current FDA listing
- Yes
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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4307-0 | 70518430700 | 30 TABLET in 1 BLISTER PACK (70518-4307-0) | 30 tablet | 2025-03-11 | No | No | Historical |
| 70518-4307-1 | 70518430701 | 90 TABLET in 1 BOTTLE, PLASTIC (70518-4307-1) | 90 tablet | 2025-05-27 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Sertraline Hydrochloride | REMEDYREPACK INC. | 2025-05-27 | HUMAN PRESCRIPTION DRUG LABEL | 2 |