Sertraline hydrochloride

Product NDC
13668-005
11-digit product format
136680005
Labeler code
13668
Product ID
13668-005_a2f71c11-af32-4d43-beac-87af9f76afc7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA077765
Marketing category
ANDA
Marketing start
2007-09-05
Marketing end
0000-00-00
Substance
SERTRALINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
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.

Current NDC status page 1 of 1 · 8 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct13668-005DDiscontinued by firm2026-08-17
excluded packagepackage13668-00513668-005-01DDiscontinued by firm2026-08-17
excluded packagepackage13668-00513668-005-05DDiscontinued by firm2026-08-17
excluded packagepackage13668-00513668-005-10DDiscontinued by firm2026-08-17
excluded packagepackage13668-00513668-005-30DDiscontinued by firm2026-08-17
excluded packagepackage13668-00513668-005-50DDiscontinued by firm2026-08-17
excluded packagepackage13668-00513668-005-58DDiscontinued by firm2026-08-17
excluded packagepackage13668-00513668-005-90DDiscontinued by firm2026-08-17

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.

Historic NDC status page 1 of 2 · 96 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13668-005-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13668-005-58d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13668-005-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13668-005-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13668-005-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13668-005-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13668-005-50d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13668-005-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13668-005-58f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13668-005-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13668-005-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13668-005-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13668-005-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13668-005-50f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13668-005-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13668-005-582ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13668-005-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13668-005-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13668-005-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13668-005-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13668-005-502ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13668-005-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13668-005-58a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13668-005-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13668-005-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13668-005-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13668-005-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13668-005-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13668-005-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13668-005-58cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13668-005-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13668-005-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13668-005-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13668-005-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13668-005-50cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13668-005-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13668-005-58cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13668-005-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13668-005-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13668-005-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13668-005-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13668-005-50cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13668-005-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13668-005-58302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13668-005-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13668-005-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13668-005-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13668-005-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13668-005-50302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage13668-005-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage13668-005-58ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage13668-005-10ed331223b511…672a5bd82f5f…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077765-001SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-06
A077765-002SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-06
A077765-003SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-06

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.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077765-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-06caaa826d4ba7…
2026-08-18 06:07:402026-07A077765-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-06caaa826d4ba7…
2026-08-18 06:07:402026-07A077765-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077765-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077765-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077765-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077765-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077765-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077765-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077765-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077765-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077765-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077765-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077765-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077765-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077765-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077765-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077765-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077765-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077765-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077765-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077765-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077765-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077765-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077765-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077765-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077765-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077765-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077765-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077765-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077765-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A077765-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A077765-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077765-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077765-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077765-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077765-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077765-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077765-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077765-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-061e350fbaab3a…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A077765-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077765-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077765-003AB174a2ff9319b5…
2020-12-22 03:56 UTC2020-12A077765-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A077765-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A077765-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077765-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A077765-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A077765-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077765-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077765-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077765-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077765-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077765-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077765-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077765-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077765-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077765-003AB1ea99ee380514…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-005-01EA - Each13668-0053e17796e-9c5d-484f-859b-05c7e3fc7b4e12012-07-24
13668-005-05EA - Each13668-005d4527c4b-efd5-47b8-8fcd-2a1522aa51c512012-07-24
13668-005-10EA - Each13668-005e57bd130-6ef6-43f3-b52d-446b1b206a2412012-07-24
13668-005-30EA - Each13668-00531761267-992f-4d1e-a01b-bcfeedc21d0812012-07-24
13668-005-50EA - Each13668-0055b2f8d14-ff43-4039-bf13-c306e333883812012-07-24
13668-005-90EA - Each13668-0050623d841-60c7-49e4-ba52-90ca1ce8af0412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SERTRALINE HYDROCHLORIDEACTIVE INGREDIENTUTI8907Y6XSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED]9
SERTRALINEACTIVE MOIETYQUC7NX6WMBSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED]9