Sertraline Hydrochloride
- Product NDC
- 68645-523
- 11-digit product format
- 686450523
- Labeler code
- 68645
- Product ID
- 68645-523_4cc29310-2a31-9e2e-e063-6294a90a8e5d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Legacy Pharmaceutical Packaging, LLC
- Application
- ANDA077397
- Marketing category
- ANDA
- Marketing start
- 2016-07-21
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sertraline Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SERTRALINE HYDROCHLORIDE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | UTI8907Y6X |
| Rxcui | 312938, 312940, 312941 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68645-523-54 | Sertraline Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68645-523 | SERTRALINE HYDROCHLORIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING, LLC] | 15 | Current NDC, Legacy NDC, 1 package rows | 20250425_bd86b293-dab9-4d37-95eb-2bffca335d16.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 |
|---|
| 68645-523-54 | 68645052354 | 30 TABLET in 1 BOTTLE (68645-523-54) | 30 tablet | 2016-07-21 | 0000-00-00 | No | No | Current |