Sertraline Hydrochloride

Product NDC
65841-043
11-digit product format
658410043
Labeler code
65841
Product ID
65841-043_8dea4705-9b8d-44e3-b7f6-9baaa785b8cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA077106
Marketing category
ANDA
Marketing start
2017-12-02
Marketing end
0000-00-00
Substance
SERTRALINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct65841-043DDiscontinued by firm2026-10-05
excluded packagepackage65841-04365841-043-01DDiscontinued by firm2026-10-05
excluded packagepackage65841-04365841-043-05DDiscontinued by firm2026-10-05
excluded packagepackage65841-04365841-043-06DDiscontinued by firm2026-10-05
excluded packagepackage65841-04365841-043-10DDiscontinued by firm2026-10-05
excluded packagepackage65841-04365841-043-14DDiscontinued by firm2026-10-05
excluded packagepackage65841-04365841-043-16DDiscontinued by firm2026-10-05
excluded packagepackage65841-04365841-043-18DDiscontinued by firm2026-10-05

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 · 8 matching rows.

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

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage65841-043-05
excluded packagepackage65841-043-16
excluded packagepackage65841-043-10
excluded packagepackage65841-043-14
excluded packagepackage65841-043-01
excluded packagepackage65841-043-18
excluded packagepackage65841-043-06

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A077106-001SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-06
A077106-002SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-06
A077106-003SERTRALINE 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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077106-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-0684e616aacf4f…
2026-09-14 22:38:342026-08A077106-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-0684e616aacf4f…
2026-09-14 22:38:342026-08A077106-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-0684e616aacf4f…
2026-08-18 06:07:402026-07A077106-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-06caaa826d4ba7…
2026-08-18 06:07:402026-07A077106-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-06caaa826d4ba7…
2026-08-18 06:07:402026-07A077106-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077106-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077106-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077106-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077106-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077106-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077106-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077106-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077106-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077106-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077106-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077106-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077106-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077106-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077106-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077106-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077106-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077106-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077106-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077106-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077106-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077106-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077106-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077106-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077106-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077106-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077106-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077106-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077106-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A077106-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A077106-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077106-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077106-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2007-02-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077106-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2007-02-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077106-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2007-02-06301d65b070ca…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-043SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]6Legacy NDC20230928_34c3d223-99bb-407d-abd4-7634f104e1f2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65841-043-0165841004301100 TABLET, FILM COATED in 1 BOTTLE (65841-043-01) 2017-12-020000-00-00NoNoCurrent
65841-043-0565841004305500 TABLET, FILM COATED in 1 BOTTLE (65841-043-05) 2017-12-020000-00-00NoNoCurrent
65841-043-066584100430630 TABLET, FILM COATED in 1 BOTTLE (65841-043-06) 2017-12-020000-00-00NoNoCurrent
65841-043-10658410043101000 TABLET, FILM COATED in 1 BOTTLE (65841-043-10) 2017-12-020000-00-00NoNoCurrent
65841-043-146584100431460 TABLET, FILM COATED in 1 BOTTLE (65841-043-14) 2017-12-020000-00-00NoNoCurrent
65841-043-166584100431690 TABLET, FILM COATED in 1 BOTTLE (65841-043-16) 2017-12-020000-00-00NoNoCurrent
65841-043-186584100431850 TABLET, FILM COATED in 1 BOTTLE (65841-043-18) 2017-12-020000-00-00NoNoCurrent