Home DailyMed 34c3d223-99bb-407d-abd4-7634f104e1f2 SERTRALINE HYDROCHLORIDE TABLETS Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
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# Product Sertraline Hydrochloride
Active ingredient SERTRALINE HYDROCHLORIDE
Label structure 1 sections
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65841-043 SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] 6 Legacy NDC 20230928_34c3d223-99bb-407d-abd4-7634f104e1f2.zip 65841-044 SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] 6 Legacy NDC 20230928_34c3d223-99bb-407d-abd4-7634f104e1f2.zip 65841-045 SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] 6 Legacy NDC 20230928_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.
Sertraline Hydrochloride SERTRALINE ALUMINUM OXIDE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 FD&C BLUE NO. 2 HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE SILICON DIOXIDE TITANIUM DIOXIDE TRIACETIN FD&C BLUE NO. 1 FERRIC OXIDE YELLOW TALC NDC Codes# Product NDC, Package NDC table Product NDC Package NDC 65841-043 65841-043-06 , 65841-043-18 , 65841-043-14 , 65841-043-16 , 65841-043-01 , 65841-043-05 , 65841-043-10 65841-044 65841-044-06 , 65841-044-14 , 65841-044-16 , 65841-044-01 , 65841-044-05 , 65841-044-10 65841-045 65841-045-06 , 65841-045-14 , 65841-045-16 , 65841-045-01 , 65841-045-40
Ingredients# Every source-derived ingredient row is available through these pages.
DailyMed ingredient rows page 1 of 1 · 36 matching rows.
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077106-001 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2007-02-06 A077106-002 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2007-02-06 A077106-003 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2007-02-06
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A077106-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2007-02-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077106-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2007-02-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077106-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2007-02-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077106-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2007-02-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077106-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2007-02-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077106-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2007-02-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077106-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2007-02-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077106-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2007-02-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077106-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2007-02-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077106-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2007-02-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077106-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2007-02-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077106-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2007-02-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077106-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2007-02-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077106-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2007-02-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077106-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2007-02-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077106-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2007-02-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077106-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2007-02-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077106-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2007-02-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077106-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2007-02-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077106-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2007-02-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077106-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2007-02-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077106-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2007-02-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077106-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2007-02-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077106-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2007-02-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077106-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2007-02-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077106-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2007-02-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077106-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2007-02-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077106-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2007-02-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077106-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2007-02-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077106-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2007-02-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077106-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2007-02-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077106-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2007-02-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077106-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2007-02-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077106-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2007-02-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077106-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2007-02-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077106-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2007-02-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077106-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2007-02-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077106-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2007-02-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077106-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2007-02-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077106-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2007-02-06 301d65b070ca…
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