Sertraline Hydrochloride

Product NDC
69097-157
11-digit product format
690970157
Labeler code
69097
Product ID
69097-157_7dc4a6a5-6ada-4c47-9e9b-65124b4eebc4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA077162
Marketing category
ANDA
Marketing start
2007-02-06
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
2018-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69097-157DDiscontinued by firm2026-08-10
excluded packagepackage69097-15769097-157-02DDiscontinued by firm2026-08-10
excluded packagepackage69097-15769097-157-05DDiscontinued by firm2026-08-10
excluded packagepackage69097-15769097-157-12DDiscontinued by firm2026-08-10

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.

Historic NDC status page 1 of 1 · 52 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69097-157-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69097-157-02DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69097-157-12DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69097-157-05DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69097-157-02DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69097-157-12DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69097-157-05DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69097-157-02DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69097-157-12DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69097-157-05DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69097-157-02DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69097-157-12DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69097-157-05DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69097-157-02DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69097-157-12DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69097-157-05DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69097-157-02DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69097-157-12DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69097-157-05DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69097-157-02DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69097-157-12DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69097-157-05DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69097-157-02DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69097-157-12DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69097-157-05DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69097-157-02DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69097-157-12DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69097-157-05DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69097-157-02DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69097-157-12DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69097-157-05DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69097-157-02DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69097-157-12DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69097-157-05DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69097-157-02DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69097-157-12DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage69097-157-12EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage69097-157-02EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage69097-157-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A077162-001SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-06
A077162-002SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-06
A077162-003SERTRALINE 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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077162-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077162-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077162-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077162-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077162-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077162-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077162-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077162-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077162-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077162-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077162-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077162-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077162-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077162-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077162-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077162-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077162-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077162-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077162-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077162-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077162-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077162-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077162-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077162-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077162-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077162-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077162-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077162-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A077162-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A077162-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077162-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077162-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077162-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077162-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077162-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077162-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077162-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077162-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077162-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077162-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-068072bd15b7f6…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
69097-157-022020-02-06These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval:1991
69097-157-052020-02-06These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval:1991
69097-157-122020-02-06These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval:1991
69097-157-022020-01-31These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval:1991
69097-157-052020-01-31These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval:1991
69097-157-122020-01-31These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval:1991

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SERTRALINE HYDROCHLORIDEACTIVE INGREDIENTUTI8907Y6XSERTRALINE HYDROCHLORIDE TABLET [CIPLA LIMITED]2
SERTRALINEACTIVE MOIETYQUC7NX6WMBSERTRALINE HYDROCHLORIDE TABLET [CIPLA LIMITED]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USERTRALINE HYDROCHLORIDE TABLET [CIPLA LIMITED]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSERTRALINE HYDROCHLORIDE TABLET [CIPLA LIMITED]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKSERTRALINE HYDROCHLORIDE TABLET [CIPLA LIMITED]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8SERTRALINE HYDROCHLORIDE TABLET [CIPLA LIMITED]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSERTRALINE HYDROCHLORIDE TABLET [CIPLA LIMITED]2
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WSERTRALINE HYDROCHLORIDE TABLET [CIPLA LIMITED]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SERTRALINE HYDROCHLORIDE TABLET [CIPLA LIMITED]2
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WESERTRALINE HYDROCHLORIDE TABLET [CIPLA LIMITED]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SERTRALINE HYDROCHLORIDE TABLET [CIPLA LIMITED]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSERTRALINE HYDROCHLORIDE TABLET [CIPLA LIMITED]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSERTRALINE HYDROCHLORIDE TABLET [CIPLA LIMITED]2