NDC 68533-057 - Sertraline Hydrochloride
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 68533-057
- Package NDCs from labels
- 68533-057-12, 68533-057-25, 68533-057-40
- Manufacturer
- Cobalt Pharmaceuticals
- Effective date
- 2007-08-02
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Sertraline Hydrochloride - Cobalt Pharmaceuticals | Cobalt Pharmaceuticals | 2007-08-02 | HUMAN PRESCRIPTION DRUG LABELING |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68533-057-12 | Sertraline Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 1 | |
| 68533-057-25 | Sertraline Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 1 | |
| 68533-057-40 | Sertraline Hydrochloride | 100 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 100 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Bryant Ranch Prepack | 82a44e20-d0ee-4ed7-9234-24ef4496ac1d | 2024-04-03 | Boxed warning, Warnings, Adverse reactions | 312941 |
| SERTRALINE | SERTRALINE | Aphena Pharma Solutions - Tennessee, LLC | 7be6a62e-0e85-47c8-8793-b41c51c2557f | 2024-03-11 | Boxed warning, Warnings, Adverse reactions | 312938 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Aurobindo Pharma Limited | 39a85db1-9e59-4ab0-9e18-36757f019faa | 2024-02-09 | Boxed warning, Warnings, Adverse reactions | 312938 312940 312941 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | NorthStar Rx LLC | 9bc362d4-489c-4e7f-915a-3076ff8d132a | 2024-02-09 | Boxed warning, Warnings, Adverse reactions | 312938 312940 312941 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | A-S Medication Solutions | 75a43476-25e0-44c3-bbab-2160041032d1 | 2023-12-25 | Boxed warning, Warnings, Adverse reactions | 312938 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | A-S Medication Solutions | 626a9271-a268-4194-935d-779377f902f5 | 2023-12-05 | Boxed warning, Warnings, Adverse reactions | 312941 |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | ScieGen Pharmaceuticals Inc | 10b9cae4-b452-4abb-866a-9f9d2568f212 | 2023-11-08 | Boxed warning, Warnings, Adverse reactions | 312938 312940 312941 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | A-S Medication Solutions | 286b429d-62b9-4ca8-a243-de3f619315bf | 2023-09-10 | Boxed warning, Warnings, Adverse reactions | 312938 312940 312941 |
| Zoloft | SERTRALINE HYDROCHLORIDE | Viatris Specialty LLC | fda754f6-d0f3-4dce-a17a-927d64f912f7 | 2023-08-08 | Boxed warning, Warnings, Adverse reactions | 312938 312940 312941 |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | XLCare Pharmaceuticals, Inc. | 5b73a90e-b883-419b-b30f-a379eed764d9 | 2023-06-14 | Boxed warning, Warnings, Adverse reactions | 312938 312940 312941 |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | A-S Medication Solutions | 14c4fa96-8919-4ea7-ad72-129f288d8cfc | 2023-05-10 | Boxed warning, Warnings, Adverse reactions | 312938 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | A-S Medication Solutions | 513ecb5b-062f-455f-b798-1c9a54222ff3 | 2023-02-28 | Boxed warning, Warnings, Adverse reactions | 312941 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Proficient Rx LP | 0f264823-1cba-4478-aef1-a8587f221dbb | 2022-12-01 | Boxed warning, Warnings, Adverse reactions | 312938 |
| Sertraline | SERTRALINE | Proficient Rx LP | 35dea1a2-ec26-4e52-8f09-ee4678e77946 | 2022-10-01 | Boxed warning, Warnings, Adverse reactions | 312938 312940 312941 |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 68c94fb4-3018-44af-b982-2b4b6d461e6f | 2022-06-24 | Boxed warning, Warnings, Adverse reactions | 312938 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Proficient Rx LP | ba201164-f6f7-4779-87a3-62780f332113 | 2022-06-01 | Boxed warning, Warnings, Adverse reactions | 312940 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Proficient Rx LP | a0b4b9c9-bd5b-4900-8abf-b55d3283c53c | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | 312941 |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Ascent Pharmaceuticals, Inc. | 056191ca-999a-4c9b-93b9-64db44b8e628 | 2021-05-10 | Boxed warning, Warnings, Adverse reactions | 312938 312940 312941 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | e815c67d-951c-4cb3-a840-f0b493b97da1 | 2020-06-23 | Boxed warning, Warnings, Adverse reactions | 312938 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Proficient Rx LP | 787a683a-091c-4908-a643-ecbc8fd467eb | 2020-02-01 | Boxed warning, Warnings, Adverse reactions | 312938 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.