Sertraline Hydrochloride
- Product NDC
- 50268-824
- 11-digit product format
- 502680824
- Labeler code
- 50268
- Product ID
- 50268-824_40be57d9-2746-0f89-e063-6394a90af4f1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- AvPAK
- Application
- ANDA077670
- Marketing category
- ANDA
- Marketing start
- 2025-10-09
- 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 |
|---|
| 50268-824-11 | Sertraline Hydrochloride | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 1 |
| 50268-824-15 | Sertraline Hydrochloride | 50 in 1 BOX | TABLET, FILM COATED | 50 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50268-824-11 | 50268082411 | 1 in 1 BLISTER PACK | | | | | Historical |
| 50268-824-15 | 50268082415 | 50 BLISTER PACK in 1 BOX (50268-824-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-824-11) | 50 blister pack | 2025-10-09 | No | No | Historical |