Sertraline Hydrochloride
- Product NDC
- 45865-518
- 11-digit product format
- 458650518
- Labeler code
- 45865
- Product ID
- 45865-518_9ab2e27f-3bec-2a90-e053-2995a90a4d3f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Medsource Pharmaceuticals
- Application
- ANDA077397
- Marketing category
- ANDA
- Marketing start
- 2007-10-18
- Marketing end
- 0000-00-00
- Substance
- SERTRALINE HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45865-518-30 | Sertraline Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
| 45865-518-60 | Sertraline Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45865-518 | SERTRALINE HYDROCHLORIDE TABLET [MEDSOURCE PHARMACEUTICALS] | 2 | Legacy NDC, 2 package rows | 20191228_1ea7e83b-e284-17f7-e054-00144ff8d46c.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 |
|---|
| 45865-518-30 | 45865051830 | 30 TABLET in 1 BOTTLE (45865-518-30) | 30 tablet | 2015-09-01 | 0000-00-00 | No | No | Current |
| 45865-518-60 | 45865051860 | 60 TABLET in 1 BOTTLE (45865-518-60) | 60 tablet | 2015-09-01 | 0000-00-00 | No | No | Current |