Sertraline Hydrochloride
- Product NDC
- 60687-231
- 11-digit product format
- 606870231
- Labeler code
- 60687
- Product ID
- 60687-231_249c2c66-cd55-acd8-e063-6394a90ad0f6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA077397
- Marketing category
- ANDA
- Marketing start
- 2017-01-30
- 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 | 312938, 312940, 312941 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60687-231-01 | Sertraline Hydrochloride | 100 in 1 BOX, UNIT-DOSE | TABLET | 100 | | 7 |
| 60687-231-11 | Sertraline Hydrochloride | 1 in 1 BLISTER PACK | TABLET | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60687-231 | SERTRALINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING] | 7 | Current NDC, Legacy NDC, 2 package rows | 20241122_4e09f580-d612-416c-a4a4-79a4411845b2.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 |
|---|
| 60687-231-01 | 60687023101 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-231-01) / 1 TABLET in 1 BLISTER PACK (60687-231-11) | 100 blister pack | 2017-01-30 | 0000-00-00 | No | No | Current |
| 60687-231-11 | 60687023111 | 1 in 1 BLISTER PACK | | | | | | Historical |