Sertraline Hydrochloride
- Product NDC
- 84386-097
- 11-digit product format
- 843860097
- Labeler code
- 84386
- Product ID
- 84386-097_b497dfeb-a48c-4f2a-b309-b56f3a26a19b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA077206
- Marketing category
- ANDA
- Marketing start
- 2025-11-20
- 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 84386-097-01 | 84386009701 | 100 TABLET, FILM COATED in 1 BOTTLE (84386-097-01) | 2025-11-20 | No | No | Historical |
| 84386-097-05 | 84386009705 | 500 TABLET, FILM COATED in 1 BOTTLE (84386-097-05) | 2025-11-20 | No | No | Historical |
| 84386-097-30 | 84386009730 | 30 TABLET, FILM COATED in 1 BOTTLE (84386-097-30) | 2025-11-20 | No | No | Historical |
| 84386-097-50 | 84386009750 | 50 TABLET, FILM COATED in 1 BOTTLE (84386-097-50) | 2025-11-20 | No | No | Historical |
| 84386-097-51 | 84386009751 | 5000 TABLET, FILM COATED in 1 BOTTLE (84386-097-51) | 2025-11-20 | No | No | Historical |
| 84386-097-60 | 84386009760 | 60 TABLET, FILM COATED in 1 BOTTLE (84386-097-60) | 2025-11-20 | No | No | Historical |
| 84386-097-90 | 84386009790 | 90 TABLET, FILM COATED in 1 BOTTLE (84386-097-90) | 2025-11-20 | No | No | Historical |
| 84386-097-99 | 84386009799 | 1000 TABLET, FILM COATED in 1 BOTTLE (84386-097-99) | 2025-11-20 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Sertraline Hydrochloride | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED | 2025-11-24 | Human Prescription Drug Label | 1 |