NDC 80425-0200-01 - 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
- 80425-0200
- Requested NDC
- 80425-0200-01
- Package NDCs from labels
- 80425-0200-1, 80425-0200-2, 80425-0200-3, 80425-0200-01
- Manufacturer
- Advanced Rx Pharmacy of Tennessee, LLC
- Effective date
- 2024-12-31
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Sertraline Hydrochloride - Advanced Rx Pharmacy of Tennessee, LLC | Advanced Rx Pharmacy of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80425-0200-1 | Sertraline Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 5 | |
| 80425-0200-2 | Sertraline Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 5 | |
| 80425-0200-3 | Sertraline Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0200 | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 5 | Current NDC, Legacy NDC, 3 package rows | 20250101_ec1b68d3-ff55-d0a2-e053-2a95a90a2e0b.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0200-1 | EA - Each | 80425-0200 | 03ef4d3e-014e-4195-8a56-83f4fc89543b | 1 | 2023-04-07 |
| 80425-0200-2 | EA - Each | 80425-0200 | 81a8962a-db14-4883-b4cf-e50f41204f20 | 1 | 2023-06-06 |
| 80425-0200-3 | EA - Each | 80425-0200 | 59e65e04-28a1-446b-9442-df5d1997a83b | 1 | 2023-06-06 |
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 | ScieGen Pharmaceuticals Inc | 10b9cae4-b452-4abb-866a-9f9d2568f212 | 2023-11-08 | Boxed warning, Warnings, Adverse reactions | 312938 312940 312941 UTI8907Y6X |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | A-S Medication Solutions | 286b429d-62b9-4ca8-a243-de3f619315bf | 2023-09-10 | Boxed warning, Warnings, Adverse reactions | ANDA077206 312938 312940 312941 UTI8907Y6X |
| sertraline HCl | SERTRALINE HYDROCHLORIDE | Almatica Pharma LLC | 8c8bcba9-eaeb-aa44-f9ea-b580de55a439 | 2023-08-24 | Boxed warning, Warnings, Adverse reactions | UTI8907Y6X |
| Zoloft | SERTRALINE HYDROCHLORIDE | Viatris Specialty LLC | fda754f6-d0f3-4dce-a17a-927d64f912f7 | 2023-08-08 | Boxed warning, Warnings, Adverse reactions | 312938 312940 312941 UTI8907Y6X |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | XLCare Pharmaceuticals, Inc. | 5b73a90e-b883-419b-b30f-a379eed764d9 | 2023-06-14 | Boxed warning, Warnings, Adverse reactions | 312938 312940 312941 UTI8907Y6X |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | A-S Medication Solutions | 14c4fa96-8919-4ea7-ad72-129f288d8cfc | 2023-05-10 | Boxed warning, Warnings, Adverse reactions | 312938 UTI8907Y6X |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | A-S Medication Solutions | 513ecb5b-062f-455f-b798-1c9a54222ff3 | 2023-02-28 | Boxed warning, Warnings, Adverse reactions | ANDA077206 312941 UTI8907Y6X |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Proficient Rx LP | 0f264823-1cba-4478-aef1-a8587f221dbb | 2022-12-01 | Boxed warning, Warnings, Adverse reactions | ANDA077206 312938 UTI8907Y6X |
| Sertraline | SERTRALINE | Proficient Rx LP | 35dea1a2-ec26-4e52-8f09-ee4678e77946 | 2022-10-01 | Boxed warning, Warnings, Adverse reactions | 312938 312940 312941 UTI8907Y6X |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 68c94fb4-3018-44af-b982-2b4b6d461e6f | 2022-06-24 | Boxed warning, Warnings, Adverse reactions | 312938 UTI8907Y6X |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Proficient Rx LP | ba201164-f6f7-4779-87a3-62780f332113 | 2022-06-01 | Boxed warning, Warnings, Adverse reactions | ANDA077206 312940 UTI8907Y6X |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Proficient Rx LP | a0b4b9c9-bd5b-4900-8abf-b55d3283c53c | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | ANDA077206 312941 UTI8907Y6X |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Ascent Pharmaceuticals, Inc. | 056191ca-999a-4c9b-93b9-64db44b8e628 | 2021-05-10 | Boxed warning, Warnings, Adverse reactions | 312938 312940 312941 UTI8907Y6X |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | e815c67d-951c-4cb3-a840-f0b493b97da1 | 2020-06-23 | Boxed warning, Warnings, Adverse reactions | ANDA077206 312938 UTI8907Y6X |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Proficient Rx LP | 787a683a-091c-4908-a643-ecbc8fd467eb | 2020-02-01 | Boxed warning, Warnings, Adverse reactions | 312938 UTI8907Y6X |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Proficient Rx LP | 00179766-980b-44b0-99d3-1fee2bb27e37 | 2019-11-01 | Boxed warning, Warnings, Adverse reactions | 312940 UTI8907Y6X |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Proficient Rx LP | 551d5946-00df-4608-96a2-b29f0ef93ba0 | 2019-11-01 | Boxed warning, Warnings, Adverse reactions | 312941 UTI8907Y6X |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Proficient Rx LP | 6b532e6a-b040-4a10-a242-fb6d8dfc0852 | 2019-11-01 | Boxed warning, Warnings, Adverse reactions | 312938 312941 UTI8907Y6X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.