Sertraline Hydrochloride
- Product NDC
- 71205-343
- 11-digit product format
- 712050343
- Labeler code
- 71205
- Product ID
- 71205-343_cdd61dcb-feb4-4c2e-ad54-cfea1a0d9545
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA077206
- Marketing category
- ANDA
- Marketing start
- 2007-02-06
- 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 |
|---|
| 71205-343-30 | Sertraline Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 71205-343-60 | Sertraline Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 2 |
| 71205-343-90 | Sertraline Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71205-343 | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP] | 2 | Current NDC, Legacy NDC, 3 package rows | 20220622_ba201164-f6f7-4779-87a3-62780f332113.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 |
|---|
| 71205-343-30 | 71205034330 | 30 TABLET, FILM COATED in 1 BOTTLE (71205-343-30) | 2019-10-01 | 0000-00-00 | No | No | Current |
| 71205-343-60 | 71205034360 | 60 TABLET, FILM COATED in 1 BOTTLE (71205-343-60) | 2019-10-01 | 0000-00-00 | No | No | Current |
| 71205-343-90 | 71205034390 | 90 TABLET, FILM COATED in 1 BOTTLE (71205-343-90) | 2019-10-01 | 0000-00-00 | No | No | Current |