Sertraline Hydrochloride
- Product NDC
- 50090-6379
- 11-digit product format
- 500906379
- Labeler code
- 50090
- Product ID
- 50090-6379_024c0025-c427-4f09-87d9-07b6a92e43a8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA077206
- Marketing category
- ANDA
- Marketing start
- 2007-02-06
- 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
openFDA Listing Details
- Product ID
- 50090-6379_024c0025-c427-4f09-87d9-07b6a92e43a8
- SPL ID
- 024c0025-c427-4f09-87d9-07b6a92e43a8
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Sertraline Hydrochloride
- Generic name
- Sertraline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing start
- 2007-02-06
- Marketing category
- ANDA
- Application number
- ANDA077206
- Pharmacologic classes
- Cytochrome P450 2D6 Inhibitors [MoA]; Serotonin Reuptake Inhibitor [EPC]; Serotonin Uptake Inhibitors [MoA]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| SERTRALINE HYDROCHLORIDE | 50 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | UTI8907Y6X |
| Rxcui | 312941 |
| Spl Set Id | 513ecb5b-062f-455f-b798-1c9a54222ff3 |
| Manufacturer Name | A-S Medication Solutions |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 50090-6379-0 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-6379-0) | 2023-02-23 | No |
| 50090-6379-1 | 60 TABLET, FILM COATED in 1 BOTTLE (50090-6379-1) | 2023-02-23 | No |
| 50090-6379-2 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6379-2) | 2023-02-23 | No |
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 |
|---|
| 50090-6379-0 | 50090637900 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-6379-0) | 2023-02-23 | No | No | Historical |
| 50090-6379-1 | 50090637901 | 60 TABLET, FILM COATED in 1 BOTTLE (50090-6379-1) | 2023-02-23 | No | No | Historical |
| 50090-6379-2 | 50090637902 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6379-2) | 2023-02-23 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Sertraline Hydrochloride | A-S Medication Solutions | 2023-02-28 | Human Prescription Drug Label | 1 |