FDA.reportPublic FDA data

sertraline (as sertraline hydrochloride) 20 MG per 1 ML Concentrate for Oral Solution

RxCUI
861064
RxNorm name
sertraline (as sertraline hydrochloride) 20 MG per 1 ML Concentrate for Oral Solution
Display name
sertraline (as sertraline hydrochloride) 20 MG per 1 ML Concentrate for Oral Solution
Full name
sertraline (as sertraline hydrochloride) 20 MG per 1 ML Concentrate for Oral Solution
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:29

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 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEMylan Pharmaceuticals Inc.1a58062b-e635-431a-908d-2651c6a4a21c2024-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861064
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEBryant Ranch Prepackfa260c6c-9f6a-46a3-91ce-5665739d87e72024-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861064
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDENorthStar Rx LLC7f144b68-ae90-483c-b030-f6824662a7342024-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861064
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDERising Pharma Holdings, Inc.af2c75a3-131e-4bde-83fd-310fd2c011612024-06-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861064
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAurobindo Pharma Limited01800452-c353-4235-a66a-214048752e742024-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861064
ZoloftSERTRALINE HYDROCHLORIDEViatris Specialty LLCfda754f6-d0f3-4dce-a17a-927d64f912f72023-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861064

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 9 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
fa260c6c-9f6a-46a3-91ce-5665739d87e7sertraline HCl 20 MG in 1 mL Concentrate for Oral Solution [PSN] · sertraline 20 MG/ML Oral Solution [SCD] · sertraline (as sertraline hydrochloride) 20 MG per 1 ML Concentrate for Oral Solution [SY]3106These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE ORAL SOLUTION. SERTRALINE HYDROCHLORIDEORAL SOLUTION, for oral use Initial U.S. Approval: 199120240819
fe9e8b7d-61ea-409d-84aa-3ebd79a046b5sertraline HCl 20 MG in 1 mL Concentrate for Oral Solution [PSN] · sertraline 20 MG/ML Oral Solution [SCD] · sertraline (as sertraline hydrochloride) 20 MG per 1 ML Concentrate for Oral Solution [SY]368These highlights do not include all the information needed to use ZOLOFT safely and effectively. See full prescribing information for ZOLOFT. ZOLOFT (sertraline hydrochloride) tablets, for oral use ZOLOFT (sertraline hydrochloride) oral solution Initial U.S. Approval: 199120230115
1a58062b-e635-431a-908d-2651c6a4a21csertraline HCl 20 MG in 1 mL Concentrate for Oral Solution [PSN] · sertraline 20 MG/ML Oral Solution [SCD] · sertraline (as sertraline hydrochloride) 20 MG per 1 ML Concentrate for Oral Solution [SY]341These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE ORAL SOLUTION . SERTRALINE HYDROCHLORIDE oral solution Initial U.S. Approval: 199120240915
01800452-c353-4235-a66a-214048752e74sertraline HCl 20 MG in 1 mL Concentrate for Oral Solution [PSN] · sertraline 20 MG/ML Oral Solution [SCD] · sertraline (as sertraline hydrochloride) 20 MG per 1 ML Concentrate for Oral Solution [SY]327These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE ORAL SOLUTION. SERTRALINE HYDROCHLORIDE oral solution Initial U.S. Approval: 199120240321
7f144b68-ae90-483c-b030-f6824662a734sertraline HCl 20 MG in 1 mL Concentrate for Oral Solution [PSN] · sertraline 20 MG/ML Oral Solution [SCD] · sertraline (as sertraline hydrochloride) 20 MG per 1 ML Concentrate for Oral Solution [SY]322These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE ORAL SOLUTION. SERTRALINE HYDROCHLORIDE oral solution Initial U.S. Approval: 199120240819
af2c75a3-131e-4bde-83fd-310fd2c01161sertraline HCl 20 MG in 1 mL Concentrate for Oral Solution [PSN] · sertraline 20 MG/ML Oral Solution [SCD] · sertraline (as sertraline hydrochloride) 20 MG per 1 ML Concentrate for Oral Solution [SY]312These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE ORAL SOLUTION. SERTRALINE HYDROCHLORIDE oral solution Initial U.S. Approval: 199120240621
f5da1754-2aed-4777-ad2e-593ee43e6e86sertraline HCl 20 MG in 1 mL Concentrate for Oral Solution [PSN] · sertraline 20 MG/ML Oral Solution [SCD] · sertraline (as sertraline hydrochloride) 20 MG per 1 ML Concentrate for Oral Solution [SY]38These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE ORAL SOLUTION. SERTRALINE HYDROCHLORIDEORAL SOLUTION, for oral use Initial U.S. Approval: 199120231217
fda754f6-d0f3-4dce-a17a-927d64f912f7sertraline HCl 20 MG in 1 mL Concentrate for Oral Solution [PSN] · sertraline 20 MG/ML Oral Solution [SCD] · sertraline (as sertraline hydrochloride) 20 MG per 1 ML Concentrate for Oral Solution [SY]37These highlights do not include all the information needed to use ZOLOFT safely and effectively. See full prescribing information for ZOLOFT. ZOLOFT (sertraline hydrochloride) tablets, for oral use ZOLOFT (sertraline hydrochloride) oral solution Initial U.S. Approval: 199120230808
c158b751-6957-44fb-bd40-73f25c9f171fsertraline HCl 20 MG in 1 mL Concentrate for Oral Solution [PSN] · sertraline 20 MG/ML Oral Solution [SCD] · sertraline (as sertraline hydrochloride) 20 MG per 1 ML Concentrate for Oral Solution [SY]31Sertraline Hydrochloride Oral Solution, USP20200406