Sertraline Hydrochloride
- Product NDC
- 43353-447
- 11-digit product format
- 433530447
- Labeler code
- 43353
- Product ID
- 43353-447_2fb33cad-68d5-7110-e063-6394a90ab175
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA077206
- Marketing category
- ANDA
- Marketing start
- 2007-02-06
- Substance
- SERTRALINE HYDROCHLORIDE
- Active strength
- 100 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 | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | UTI8907Y6X |
| Rxcui | 312938 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43353-447-15 | Sertraline Hydrochloride | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 2 |
| 43353-447-30 | Sertraline Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 43353-447-45 | Sertraline Hydrochloride | 45 in 1 BOTTLE | TABLET, FILM COATED | 45 | | 2 |
| 43353-447-53 | Sertraline Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 2 |
| 43353-447-73 | Sertraline Hydrochloride | 135 in 1 BOTTLE | TABLET, FILM COATED | 135 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-447 | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | Current NDC, Legacy NDC, 5 package rows | 20250309_680890b1-bc45-4f50-9aaf-e730ab515b85.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43353-447-15 | 43353044715 | 15 TABLET, FILM COATED in 1 BOTTLE (43353-447-15) | 2018-07-31 | 0000-00-00 | No | No | Current |
| 43353-447-30 | 43353044730 | 30 TABLET, FILM COATED in 1 BOTTLE (43353-447-30) | 2018-07-31 | 0000-00-00 | No | No | Current |
| 43353-447-45 | 43353044745 | 45 TABLET, FILM COATED in 1 BOTTLE (43353-447-45) | 2018-07-31 | 0000-00-00 | No | No | Current |
| 43353-447-53 | 43353044753 | 60 TABLET, FILM COATED in 1 BOTTLE (43353-447-53) | 2018-07-31 | 0000-00-00 | No | No | Current |
| 43353-447-73 | 43353044773 | 135 TABLET, FILM COATED in 1 BOTTLE (43353-447-73) | 2025-03-05 | | No | No | Current |