FDA.reportPublic FDA data

sertraline (as sertraline HCl) 25 MG Oral Tablet

RxCUI
312940
RxNorm name
sertraline (as sertraline HCl) 25 MG Oral Tablet
Display name
sertraline (as sertraline HCl) 25 MG Oral Tablet
Full name
sertraline (as sertraline HCl) 25 MG Oral Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:26

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 3 · 54 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEREMEDYREPACK INC.7d598f1a-6c76-458a-a155-7a6a0743a2d32026-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEREMEDYREPACK INC.455c8416-c878-4283-a42f-4df896870a4e2026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.b559c20d-70be-41e7-acfb-262ffc3ea8782026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.1afd0016-d0ee-4e25-a1a4-b66f228e2f9c2026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
SertralineSERTRALINEPreferred Pharmaceuticals Inc.957ba196-0b9b-4cda-bd15-28357ced8d2f2026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDECoupler LLC56442b06-c135-a035-e063-6394a90a171b2026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEUnit Dose Solutions, Inc.55f514c6-f6ec-13ac-e063-6294a90ac9572026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEBryant Ranch Prepack9c0a7f78-9cac-4e82-b971-f3f9758f8a0c2026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEREMEDYREPACK INC.575da603-b038-421f-9894-6796d9ac33cc2026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEBryant Ranch Prepacke919f195-0ce1-4d71-9883-efec05b9a0502026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEREMEDYREPACK INC.268bd7f7-bc17-4850-ab7c-1b73caa564d52026-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDECoupler LLC4f94a6d7-8719-834c-e063-6294a90a34482026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEGranules Pharmaceuticals Inc.98960cc1-1d44-4d89-b415-7e250cc762cc2026-04-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
SertralineSERTRALINEREMEDYREPACK INC.f515d1e7-5803-4797-b3cc-8dbea85d96e52026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDELegacy Pharmaceutical Packaging, LLCbd86b293-dab9-4d37-95eb-2bffca335d162026-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
SertralineSERTRALINEA-S Medication Solutionse46bc887-69e2-4037-be59-6513277d157b2026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDECipla USA Inc.cf71d1b9-5ebb-429f-a07f-a87cd168250f2026-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labsfd92c8d3-17ec-477c-bc25-e5239c8606ac2026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.48702ef4-21cd-754e-e063-6394a90af24e2026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
SertralineSERTRALINEAvPAK10baaffd-061e-d665-e063-6294a90a15942026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 3 of 3 · 85 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
c67bc43d-d341-47c6-8b81-a7ad4cdb1207sertraline HCl 25 MG Oral Tablet [PSN] · sertraline 25 MG Oral Tablet [SCD] · sertraline (as sertraline HCl) 25 MG Oral Tablet [SY]31These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 199120250623
f705f743-40e9-42bf-88f5-6dd7e5d5ba94sertraline HCl 25 MG Oral Tablet [PSN] · sertraline 25 MG Oral Tablet [SCD] · sertraline (as sertraline HCl) 25 MG Oral Tablet [SY]31Sertraline Hydrochloride tablets 25 mg, 50 mg, and 100 mg Tablets These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval:199120241025
e8c184d1-d4a0-7777-e053-2995a90a51ccsertraline HCl 25 MG Oral Tablet [PSN] · sertraline 25 MG Oral Tablet [SCD] · sertraline (as sertraline HCl) 25 MG Oral Tablet [SY]31These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE TABLETS, for oral use Initial U.S. Approval: 199120220922
d2f94500-633e-486e-9c03-2b02266b08e7sertraline HCl 25 MG Oral Tablet [PSN] · sertraline 25 MG Oral Tablet [SCD] · sertraline (as sertraline HCl) 25 MG Oral Tablet [SY]31SERTRALINE HYDROCHLORIDE Tablets and Oral Concentrate20100608
c7ab46cd-b3a0-3f9e-97e6-e6125e1a52a2sertraline HCl 25 MG Oral Tablet [PSN] · sertraline 25 MG Oral Tablet [SCD] · sertraline (as sertraline HCl) 25 MG Oral Tablet [SY]31SERTRALINE HYDROCHLORIDE TABLETS20070802