Sertraline Hydrochloride
- Product NDC
- 53002-3215
- 11-digit product format
- 530023215
- Labeler code
- 53002
- Product ID
- 53002-3215_684bc9dd-0438-4984-9d47-a5c9a3b24462
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA077206
- Marketing category
- ANDA
- Marketing start
- 2007-02-06
- Marketing end
- 0000-00-00
- Substance
- SERTRALINE HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 |
|---|
| 53002-3215-0 | 2025-01-30 | C162847 | 48780-1 | f386c649-a93d-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991 |
| 53002-3215-3 | 2025-01-30 | C162847 | 48780-1 | f386c649-a93d-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991 |
| 53002-3215-6 | 2025-01-30 | C162847 | 48780-1 | f386c649-a93d-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991 |
| 53002-3215-0 | 2023-06-07 | C162847 | 48780-1 | f386c649-a93d-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991 |
| 53002-3215-3 | 2023-06-07 | C162847 | 48780-1 | f386c649-a93d-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991 |
| 53002-3215-6 | 2023-06-07 | C162847 | 48780-1 | f386c649-a93d-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991 |
| 53002-3215-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-a93d-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991 |
| 53002-3215-3 | 2023-01-30 | C162847 | 48780-1 | f386c649-a93d-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991 |
| 53002-3215-6 | 2023-01-30 | C162847 | 48780-1 | f386c649-a93d-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-3215-0 | Sertraline Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 3 |
| 53002-3215-3 | Sertraline Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 53002-3215-6 | Sertraline Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-3215 | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.] | 3 | Legacy NDC, 3 package rows | 20230609_52f07cd1-308e-4456-af07-48d1c261e433.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 |
|---|
| 53002-3215-0 | 53002321500 | 100 TABLET, FILM COATED in 1 BOTTLE (53002-3215-0) | 2019-01-01 | 0000-00-00 | No | No | Current |
| 53002-3215-3 | 53002321503 | 30 TABLET, FILM COATED in 1 BOTTLE (53002-3215-3) | 2019-01-01 | 0000-00-00 | No | No | Current |
| 53002-3215-6 | 53002321506 | 60 TABLET, FILM COATED in 1 BOTTLE (53002-3215-6) | 2019-01-01 | 0000-00-00 | No | No | Current |