Home NDC 59762-4960 SERTRALINE HYDROCHLORIDE
Product NDC 59762-4960
11-digit product format 597624960
Labeler code 59762
Product ID 59762-4960_e8b9ac1b-99e2-4eaa-adba-6c9ce4e254d5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sertraline hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Greenstone LLC
Application NDA019839
Marketing category NDA AUTHORIZED GENERIC
Marketing start 1992-02-11
Marketing end 0000-00-00
Substance SERTRALINE HYDROCHLORIDE
Active strength 25 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 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 59762-4960-1 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 59762-4960-1 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 59762-4960-1 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 59762-4960-1 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 59762-4960-1 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 59762-4960-1 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 59762-4960-1 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 59762-4960-1 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 59762-4960-1 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 59762-4960-1 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 59762-4960-1 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 59762-4960-1 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019839-001 ZOLOFT SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB RLD 1991-12-30 N019839-002 ZOLOFT SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB RLD, RS 1991-12-30 N019839-003 ZOLOFT SERTRALINE HYDROCHLORIDE EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 N019839-004 ZOLOFT SERTRALINE HYDROCHLORIDE EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 N019839-005 ZOLOFT SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB RLD 1996-03-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 6 · 210 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 N019839-001 ZOLOFT EQ 50MG BASE TABLET / ORAL AB RLD 1991-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019839-002 ZOLOFT EQ 100MG BASE TABLET / ORAL AB RLD, RS 1991-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019839-003 ZOLOFT EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019839-004 ZOLOFT EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019839-005 ZOLOFT EQ 25MG BASE TABLET / ORAL AB RLD 1996-03-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019839-001 ZOLOFT EQ 50MG BASE TABLET / ORAL AB RLD 1991-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019839-002 ZOLOFT EQ 100MG BASE TABLET / ORAL AB RLD, RS 1991-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019839-003 ZOLOFT EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019839-004 ZOLOFT EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019839-005 ZOLOFT EQ 25MG BASE TABLET / ORAL AB RLD 1996-03-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019839-001 ZOLOFT EQ 50MG BASE TABLET / ORAL AB RLD 1991-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019839-002 ZOLOFT EQ 100MG BASE TABLET / ORAL AB RLD, RS 1991-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019839-003 ZOLOFT EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019839-004 ZOLOFT EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019839-005 ZOLOFT EQ 25MG BASE TABLET / ORAL AB RLD 1996-03-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019839-001 ZOLOFT EQ 50MG BASE TABLET / ORAL AB RLD 1991-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019839-002 ZOLOFT EQ 100MG BASE TABLET / ORAL AB RLD, RS 1991-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019839-003 ZOLOFT EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019839-004 ZOLOFT EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019839-005 ZOLOFT EQ 25MG BASE TABLET / ORAL AB RLD 1996-03-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019839-001 ZOLOFT EQ 50MG BASE TABLET / ORAL AB RLD 1991-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019839-002 ZOLOFT EQ 100MG BASE TABLET / ORAL AB RLD, RS 1991-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019839-003 ZOLOFT EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019839-004 ZOLOFT EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019839-005 ZOLOFT EQ 25MG BASE TABLET / ORAL AB RLD 1996-03-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019839-001 ZOLOFT EQ 50MG BASE TABLET / ORAL AB RLD 1991-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019839-002 ZOLOFT EQ 100MG BASE TABLET / ORAL AB RLD, RS 1991-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019839-003 ZOLOFT EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019839-004 ZOLOFT EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019839-005 ZOLOFT EQ 25MG BASE TABLET / ORAL AB RLD 1996-03-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019839-001 ZOLOFT EQ 50MG BASE TABLET / ORAL AB RLD 1991-12-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019839-002 ZOLOFT EQ 100MG BASE TABLET / ORAL AB RLD, RS 1991-12-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019839-003 ZOLOFT EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019839-004 ZOLOFT EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019839-005 ZOLOFT EQ 25MG BASE TABLET / ORAL AB RLD 1996-03-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019839-001 ZOLOFT EQ 50MG BASE TABLET / ORAL AB RLD 1991-12-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019839-002 ZOLOFT EQ 100MG BASE TABLET / ORAL AB RLD, RS 1991-12-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019839-003 ZOLOFT EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019839-004 ZOLOFT EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019839-005 ZOLOFT EQ 25MG BASE TABLET / ORAL AB RLD 1996-03-06 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
DailyMed Product Concepts# 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 [PHYSICIANS TOTAL CARE, INC.] 8 SERTRALINE ACTIVE MOIETY QUC7NX6WMB SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 8 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 8 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 8 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 8 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 8 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 8 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 8 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 8 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 8 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 8 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 8 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 8 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 8
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Zoloft SERTRALINE HYDROCHLORIDE Viatris Specialty LLC fda754f6-d0f3-4dce-a17a-927d64f912f7 2023-08-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 019839 application number: NDA019839
DailyMed RxNorm Mappings#