Sertraline hydrochloride
- Product NDC
- 50090-7395
- 11-digit product format
- 500907395
- Labeler code
- 50090
- Product ID
- 50090-7395_7e6058fe-fd67-4178-81db-fc63e88b573b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA078403
- Marketing category
- ANDA
- Marketing start
- 2023-05-15
- 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
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 | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | UTI8907Y6X |
| Rxcui | 312940 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-7395-0 | Sertraline hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 50090-7395-1 | Sertraline hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-7395 | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 1 | Current NDC, 2 package rows | 20241027_4f6f2412-8085-45bf-be4f-63e44490a34e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-7395-0 | 50090739500 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-7395-0) | 2024-10-23 | No | No | Current |
| 50090-7395-1 | 50090739501 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-7395-1) | 2024-10-23 | No | No | Current |