Sertraline Hydrochloride
- Product NDC
- 84386-098
- 11-digit product format
- 843860098
- Labeler code
- 84386
- Product ID
- 84386-098_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
- 50 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sertraline Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SERTRALINE HYDROCHLORIDE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | UTI8907Y6X |
| Rxcui | 312938, 312940, 312941 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 84386-098-01 | Sertraline Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1 |
| 84386-098-05 | Sertraline Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 1 |
| 84386-098-30 | Sertraline Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 84386-098-50 | Sertraline Hydrochloride | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | | 1 |
| 84386-098-51 | Sertraline Hydrochloride | 5000 in 1 BOTTLE | TABLET, FILM COATED | 5000 | | 1 |
| 84386-098-60 | Sertraline Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
| 84386-098-90 | Sertraline Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
| 84386-098-99 | Sertraline Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 84386-098-01 | 84386009801 | 100 TABLET, FILM COATED in 1 BOTTLE (84386-098-01) | 2025-11-20 | No | No | Historical |
| 84386-098-05 | 84386009805 | 500 TABLET, FILM COATED in 1 BOTTLE (84386-098-05) | 2025-11-20 | No | No | Historical |
| 84386-098-30 | 84386009830 | 30 TABLET, FILM COATED in 1 BOTTLE (84386-098-30) | 2025-11-20 | No | No | Historical |
| 84386-098-50 | 84386009850 | 50 TABLET, FILM COATED in 1 BOTTLE (84386-098-50) | 2025-11-20 | No | No | Historical |
| 84386-098-51 | 84386009851 | 5000 TABLET, FILM COATED in 1 BOTTLE (84386-098-51) | 2025-11-20 | No | No | Historical |
| 84386-098-60 | 84386009860 | 60 TABLET, FILM COATED in 1 BOTTLE (84386-098-60) | 2025-11-20 | No | No | Historical |
| 84386-098-90 | 84386009890 | 90 TABLET, FILM COATED in 1 BOTTLE (84386-098-90) | 2025-11-20 | No | No | Historical |
| 84386-098-99 | 84386009899 | 1000 TABLET, FILM COATED in 1 BOTTLE (84386-098-99) | 2025-11-20 | No | No | Historical |