Sertraline Hydrochloride
- Product NDC
- 60760-611
- 11-digit product format
- 607600611
- Labeler code
- 60760
- Product ID
- 60760-611_7ad0d302-82ba-62e9-e053-2a91aa0ae128
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- St. Mary's Medical Park Pharmacy
- Application
- ANDA077206
- Marketing category
- ANDA
- Marketing start
- 2007-02-06
- Marketing end
- 0000-00-00
- Substance
- SERTRALINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 | 60760-611 | D | Discontinued by firm | 2026-08-07 | ||
| excluded package | package | 60760-611 | 60760-611-30 | D | Discontinued by firm | 2026-08-07 |
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 | 60760-611-30 | 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 | 60760-611-30 | 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 | 60760-611-30 | 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 | 60760-611-30 | 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 | 60760-611-30 | 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 | 60760-611-30 | 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 | 60760-611-30 | 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 | 60760-611-30 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 60760-611-30 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 60760-611-30 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 60760-611-30 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 60760-611-30 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077206-001 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | |
| A077206-002 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | |
| A077206-003 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077206-001 | AB |
| A077206-002 | AB |
| A077206-003 | AB |
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 | A077206-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077206-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077206-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077206-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077206-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077206-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077206-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077206-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077206-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077206-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077206-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077206-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077206-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077206-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077206-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077206-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077206-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077206-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077206-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077206-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077206-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077206-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077206-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077206-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077206-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077206-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077206-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077206-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077206-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077206-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077206-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077206-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077206-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077206-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077206-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077206-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077206-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077206-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077206-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077206-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077206-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077206-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077206-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077206-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077206-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077206-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077206-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077206-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077206-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077206-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077206-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077206-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077206-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077206-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077206-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077206-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077206-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077206-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077206-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077206-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077206-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077206-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077206-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077206-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077206-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077206-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077206-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077206-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077206-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077206-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077206-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077206-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077206-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077206-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077206-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077206-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077206-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077206-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077206-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077206-001 | AB | 1 | 8072bd15b7f6… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60760-611-30 | EA - Each | 60760-611 | 01e8b125-7a96-4134-9e16-a37c6c973a6f | 1 | 2018-01-12 |
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 | REMEDYREPACK INC. | 91e24d17-ff0a-449c-9472-b9df74c98456 | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | REMEDYREPACK INC. | a2f333af-d37b-4705-ab7a-d363e3186e6e | 2026-07-24 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Unit Dose Solutions, Inc. | 561a8a20-be26-c4f8-e063-6394a90af072 | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Unit Dose Solutions, Inc. | 561e7498-a606-366d-e063-6394a90a1c6a | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | REMEDYREPACK INC. | 575da603-b038-421f-9894-6796d9ac33cc | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 8d444aec-cf33-b769-e053-2995a90a54be | 2026-06-02 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Coupler LLC | 518caa95-2cd7-a293-e063-6394a90adbd0 | 2026-05-11 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 7f81de84-0ad7-f050-e053-2a91aa0aa762 | 2026-05-05 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Coupler LLC | 5103d12c-9453-a855-e063-6294a90a6f0c | 2026-05-04 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | A-S Medication Solutions | 7f62789b-61df-4b7b-9e01-c7a4dfb7e73c | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | A-S Medication Solutions | 90524e6e-c34f-43eb-8c30-d99faf7ae08f | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Northwind Health Company, LLC | ab0b0ef7-155b-cec9-e053-2a95a90a9fce | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Northwind Health Company, LLC | ab1bb71f-936d-cb40-e053-2a95a90a08bb | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | QPharma Inc | 664d1744-7b1d-43e2-98ba-1b0e69d75840 | 2025-12-03 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Aurobindo Pharma Limited | b497dfeb-a48c-4f2a-b309-b56f3a26a19b | 2025-11-24 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Bryant Ranch Prepack | b400fed8-f425-47ff-ab42-915cb6e7f152 | 2025-11-06 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 8f5a71b2-2821-46a0-ac65-28d9b2db73ec | 2025-10-17 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 3ca30f3f-545e-46c5-b56a-73ec48e9647f | 2025-10-09 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 91b4c802-9c6b-49bb-b5a7-661e1917ef34 | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 677c90cd-6527-40cb-a564-571796513fcb | 2025-09-19 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 60760-611-30 | 60760061130 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-611-30) | 2017-11-20 | 0000-00-00 | No | No | Current |