Home NDC 58151-574 Zoloft
Product NDC 58151-574
11-digit product format 581510574
Labeler code 58151
Product ID 58151-574_fd27d2f5-1ade-4dbf-b2d2-bb98daf7da3a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sertraline hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Viatris Specialty LLC
Application NDA019839
Marketing category NDA
Marketing start 2024-10-30
Substance SERTRALINE HYDROCHLORIDE
Active strength 25 mg/1
Pharmacologic classes Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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ZOLOFT SERTRALINE HYDROCHLORIDE EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 N019839-004 ZOLOFT SERTRALINE HYDROCHLORIDE EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 N019839-005 ZOLOFT SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB RLD 1996-03-06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.
Additional Listing Data#
Finished product Yes
Brand name base Zoloft
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SERTRALINE HYDROCHLORIDE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination UTI8907Y6X Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 208149 Internal RxNorm lookup 208161 Internal RxNorm lookup 212233 Internal RxNorm lookup 312938 Internal RxNorm lookup 312940 Internal RxNorm lookup 312941 Internal RxNorm lookup 861064 Internal RxNorm lookup 861066 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58151-574-93 Zoloft 30 in 1 BOTTLE TABLET, FILM COATED 30 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58151-574 ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [VIATRIS SPECIALTY LLC] 4 Current NDC, 1 package rows 20241206_fda754f6-d0f3-4dce-a17a-927d64f912f7.zip
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 ndc (product): 58151-574
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 58151-574-93 58151057493 30 TABLET, FILM COATED in 1 BOTTLE (58151-574-93) 2024-10-30 No No Current