Sertraline Hydrochloride
- Product NDC
- 43353-787
- 11-digit product format
- 433530787
- Labeler code
- 43353
- Product ID
- 43353-787_01211049-3b2e-4d9c-a26b-ff2b30bcb118
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sertraline
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, Inc.
- Application
- ANDA078626
- Marketing category
- ANDA
- Marketing start
- 2012-02-03
- 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
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 43353-787 | D | Discontinued by firm | 2026-08-10 | ||
| excluded package | package | 43353-787 | 43353-787-15 | D | Discontinued by firm | 2026-08-10 | |
| excluded package | package | 43353-787 | 43353-787-30 | D | Discontinued by firm | 2026-08-10 | |
| excluded package | package | 43353-787 | 43353-787-45 | D | Discontinued by firm | 2026-08-10 | |
| excluded package | package | 43353-787 | 43353-787-53 | D | Discontinued by firm | 2026-08-10 | |
| excluded package | package | 43353-787 | 43353-787-60 | D | Discontinued by firm | 2026-08-10 | |
| excluded package | package | 43353-787 | 43353-787-73 | D | Discontinued by firm | 2026-08-10 | |
| excluded package | package | 43353-787 | 43353-787-80 | D | Discontinued by firm | 2026-08-10 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 43353-787-53 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 43353-787-45 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 43353-787-30 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 43353-787-15 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 43353-787-80 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 43353-787-73 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 43353-787-60 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 43353-787-53 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 43353-787-45 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 43353-787-30 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 43353-787-15 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 43353-787-80 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 43353-787-73 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 43353-787-60 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 43353-787-53 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 43353-787-45 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 43353-787-30 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 43353-787-15 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 43353-787-80 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 43353-787-73 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 43353-787-60 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 43353-787-53 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 43353-787-45 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 43353-787-30 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 43353-787-15 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 43353-787-80 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 43353-787-73 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 43353-787-60 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 43353-787-53 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 43353-787-45 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 43353-787-30 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 43353-787-15 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 43353-787-80 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 43353-787-73 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 43353-787-60 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 43353-787-53 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 43353-787-45 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 43353-787-30 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 43353-787-15 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 43353-787-80 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 43353-787-73 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 43353-787-60 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 43353-787-53 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 43353-787-45 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 43353-787-30 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 43353-787-15 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 43353-787-80 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 43353-787-73 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 43353-787-60 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 43353-787-53 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 43353-787-45 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 43353-787-30 | ed331223b511… | 672a5bd82f5f… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078626-001 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2008-01-31 | ||
| A078626-002 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2008-01-31 | ||
| A078626-003 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2008-01-31 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078626-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2008-01-31 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078626-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2008-01-31 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078626-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2008-01-31 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078626-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2008-01-31 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078626-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2008-01-31 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078626-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2008-01-31 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078626-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2008-01-31 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078626-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2008-01-31 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078626-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2008-01-31 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078626-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2008-01-31 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078626-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2008-01-31 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078626-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2008-01-31 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078626-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2008-01-31 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078626-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2008-01-31 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078626-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2008-01-31 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078626-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2008-01-31 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078626-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2008-01-31 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078626-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2008-01-31 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078626-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2008-01-31 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078626-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2008-01-31 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078626-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2008-01-31 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078626-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2008-01-31 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078626-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2008-01-31 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078626-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2008-01-31 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078626-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2008-01-31 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078626-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2008-01-31 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078626-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2008-01-31 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078626-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2008-01-31 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078626-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2008-01-31 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078626-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2008-01-31 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078626-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2008-01-31 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078626-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2008-01-31 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078626-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2008-01-31 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078626-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2008-01-31 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078626-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2008-01-31 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078626-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2008-01-31 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078626-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2008-01-31 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078626-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2008-01-31 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078626-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2008-01-31 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A078626-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2008-01-31 | 8072bd15b7f6… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43353-787-15 | EA - Each | 43353-787 | 03dedb45-0ea5-4de0-9971-0f5627b00aef | 1 | 2013-04-01 |
| 43353-787-30 | EA - Each | 43353-787 | a1b09dea-4e44-4e99-9812-b2bc48565a7f | 1 | 2013-04-01 |
| 43353-787-45 | EA - Each | 43353-787 | dfaab8ee-053d-4b12-8237-77acac0af413 | 1 | 2013-04-01 |
| 43353-787-53 | EA - Each | 43353-787 | 666a5d0d-fc1d-42d1-95d1-be43ae2a5152 | 1 | 2013-04-01 |
| 43353-787-60 | EA - Each | 43353-787 | 1c743356-6c97-41f4-983a-8cbe20ab50d8 | 1 | 2013-04-01 |
| 43353-787-73 | EA - Each | 43353-787 | f04bf1ff-b945-429d-93fe-756e25f5dfa5 | 1 | 2013-04-01 |
| 43353-787-80 | EA - Each | 43353-787 | 121339a5-9d59-4f7c-b359-56cb3125f4b1 | 1 | 2013-04-01 |