Sertraline Hydrochloride
- Product NDC
- 53217-242
- 11-digit product format
- 532170242
- Labeler code
- 53217
- Product ID
- 53217-242_c5bbefe1-3d7f-4687-a8f4-b11782d014c0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA077397
- Marketing category
- ANDA
- Marketing start
- 2016-07-21
- 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
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 53217-242-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-dde7-f424-e053-dadaa90a57ce | Sertraline Tablets, USP 25mg, 50mg and 100 mg |
| 53217-242-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-dde7-f424-e053-dadaa90a57ce | Sertraline Tablets, USP 25mg, 50mg and 100 mg |
| 53217-242-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-dde7-f424-e053-dadaa90a57ce | Sertraline Tablets, USP 25mg, 50mg and 100 mg |
| 53217-242-90 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-dde7-f424-e053-dadaa90a57ce | Sertraline Tablets, USP 25mg, 50mg and 100 mg |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53217-242-02 | Sertraline Hydrochloride | 120 in 1 BOTTLE | TABLET | 120 | | 1 |
| 53217-242-30 | Sertraline Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 53217-242-60 | Sertraline Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
| 53217-242-90 | Sertraline Hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53217-242 | SERTRALINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | Legacy NDC, 4 package rows | 20161130_59287bc1-ac6f-47d2-84ba-b52f32f5894f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53217-242-02 | 53217024202 | 120 in 1 BOTTLE | Historical |
| 53217-242-30 | 53217024230 | 30 in 1 BOTTLE | Historical |
| 53217-242-60 | 53217024260 | 60 in 1 BOTTLE | Historical |
| 53217-242-90 | 53217024290 | 90 in 1 BOTTLE | Historical |