SERTRALINE HYDROCHLORIDE TABLETS

Manufacturer
Zydus Lifesciences Limited
Effective date
2023-09-27
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:25:32

Label at a glance#

ProductSertraline Hydrochloride
Active ingredientSERTRALINE HYDROCHLORIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-043-06 in bottles of 30 tablets

Sertraline Hydrochloride Tablets, 25 mg

30 Tablets

sertraline tablets 25 mg
sertraline tablets 25 mg

NDC 65841-044-06 in bottles of 30 tablets

Sertraline Hydrochloride Tablets, 50 mg

30 Tablets

sertraline tablets 50 mg
sertraline tablets 50 mg

NDC 65841-045-06 in bottles of 30 tablets

Sertraline Hydrochloride Tablets, 100 mg

30 Tablets

sertraline tablets 100 mg
sertraline tablets 100 mg

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
65841-044SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]6Legacy NDC20230928_34c3d223-99bb-407d-abd4-7634f104e1f2.zip
65841-045SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]6Legacy NDC20230928_34c3d223-99bb-407d-abd4-7634f104e1f2.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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…

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0db1f24f-aa10-405b-8936-d67298fbdc1434c3d223-99bb-407d-abd4-7634f104e1f22025-08-25Exact identifier
spl set id: 34c3d223-99bb-407d-abd4-7634f104e1f2

Reported adverse events (FAERS/openFDA)#

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