sertraline HCl
- Product NDC
- 52427-672
- 11-digit product format
- 524270672
- Labeler code
- 52427
- Product ID
- 52427-672_fee38eb1-855e-a3c0-c707-8665f61fb400
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sertraline hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Almatica Pharma LLC
- Application
- NDA215133
- Marketing category
- NDA
- Marketing start
- 2021-10-04
- Substance
- SERTRALINE HYDROCHLORIDE
- Active strength
- 200 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 HCl
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SERTRALINE HYDROCHLORIDE | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | UTI8907Y6X |
| Rxcui | 251201, 410584 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 52427-672-30 | sertraline HCl | 30 in 1 BOTTLE | CAPSULE | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52427-672 | SERTRALINE HCL (SERTRALINE HYDROCHLORIDE) CAPSULE [ALMATICA PHARMA LLC] | 4 | Current NDC, Legacy NDC, 1 package rows | 20241011_8c8bcba9-eaeb-aa44-f9ea-b580de55a439.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 52427-672-30 | 52427067230 | 30 CAPSULE in 1 BOTTLE (52427-672-30) | 30 capsule | 2021-11-01 | 0000-00-00 | No | No | Current |