Home DailyMed 5868c75f-3c2f-4564-8a67-e64ae5d7eba5 National Council for Prescription Drug Programs indexing - billing unit 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 National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 01:51:08 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 · 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ZOLOFT SERTRALINE HYDROCHLORIDE EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 N019839-004 ZOLOFT SERTRALINE HYDROCHLORIDE EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 N019839-005 ZOLOFT SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB RLD 1996-03-06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 · 215 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 N019839-001 ZOLOFT EQ 50MG BASE TABLET / ORAL AB RLD 1991-12-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019839-002 ZOLOFT EQ 100MG BASE TABLET / ORAL AB RLD, RS 1991-12-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 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 84e616aacf4f…2026-09-14 22:38:34 2026-08 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 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019839-005 ZOLOFT EQ 25MG BASE TABLET / ORAL AB RLD 1996-03-06 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.