Home NDC 59115-054 Sertraline Hydrochloride
Product NDC 59115-054
11-digit product format 591150054
Labeler code 59115
Product ID 59115-054_ece847e7-955f-46ab-ace4-eac58d4d9ac4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sertraline hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Hikma Pharmaceutical
Application ANDA077864
Marketing category ANDA
Marketing start 2009-08-10
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 2020-12-31
Current FDA listing Historical FDA.report record 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077864-001 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2009-08-10 A077864-002 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2009-08-10 A077864-003 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2009-08-10
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A077864-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2009-08-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077864-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2009-08-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077864-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2009-08-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077864-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2009-08-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077864-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2009-08-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077864-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2009-08-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077864-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2009-08-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077864-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2009-08-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077864-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2009-08-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077864-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2009-08-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077864-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2009-08-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077864-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2009-08-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077864-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2009-08-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077864-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2009-08-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077864-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2009-08-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077864-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2009-08-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077864-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2009-08-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077864-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2009-08-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077864-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2009-08-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077864-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2009-08-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077864-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2009-08-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077864-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2009-08-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077864-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2009-08-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077864-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2009-08-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077864-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2009-08-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077864-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2009-08-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077864-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2009-08-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077864-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2009-08-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077864-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2009-08-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077864-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2009-08-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077864-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2009-08-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077864-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2009-08-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077864-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2009-08-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077864-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2009-08-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077864-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2009-08-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077864-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2009-08-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077864-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2009-08-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077864-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2009-08-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077864-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2009-08-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077864-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2009-08-10 1e350fbaab3a…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SERTRALINE HYDROCHLORIDE ACTIVE INGREDIENT UTI8907Y6X SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICAL] 3 SERTRALINE ACTIVE MOIETY QUC7NX6WMB SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICAL] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICAL] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICAL] 3 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICAL] 3 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICAL] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICAL] 3 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICAL] 3 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICAL] 3 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICAL] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICAL] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICAL] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICAL] 3