FDA.reportPublic FDA data

NDC 50090-0989-02 - SERTRALINE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
50090-0989
Requested NDC
50090-0989-02
Package NDCs from labels
50090-0989-0, 50090-0989-1, 50090-0989-2, 50090-0989-02
Manufacturer
A-S Medication Solutions
Effective date
2026-07-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SERTRALINE - A-S Medication SolutionsA-S Medication Solutions2026-07-14HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-0989-02023-02-07These 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: 1991
50090-0989-02023-02-07These 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: 1991
50090-0989-12023-02-07These 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: 1991
50090-0989-12023-02-07These 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: 1991
50090-0989-22023-02-07These 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: 1991
50090-0989-22023-02-07These 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: 1991
50090-0989-02023-01-30These 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: 1991
50090-0989-02023-01-30These 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: 1991
50090-0989-12023-01-30These 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: 1991
50090-0989-12023-01-30These 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: 1991
50090-0989-22023-01-30These 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: 1991
50090-0989-22023-01-30These 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: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0989-0Sertraline30 in 1 BOTTLETABLET, FILM COATED308
50090-0989-1Sertraline60 in 1 BOTTLETABLET, FILM COATED608
50090-0989-2Sertraline90 in 1 BOTTLETABLET, FILM COATED908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0989SERTRALINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 3 package rows20230208_7b5c29ff-25c8-4b68-844d-b8e95be7d09b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0989-0EA - Each50090-0989417fd318-cfbd-4983-b8af-3c0b9135f68012022-12-07
50090-0989-1EA - Each50090-0989777fbb5d-5ca1-4861-b333-81b29fcb73ae12022-12-07
50090-0989-2EA - Each50090-0989a060fdd1-85f7-43c2-8916-08441099110212022-12-07

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 113 · 2,241 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEREMEDYREPACK INC.7d598f1a-6c76-458a-a155-7a6a0743a2d32026-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
unii: UTI8907Y6X
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEREMEDYREPACK INC.455c8416-c878-4283-a42f-4df896870a4e2026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.b559c20d-70be-41e7-acfb-262ffc3ea8782026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.5921f77f-01a2-40b9-ad77-2258865c997d2026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
unii: UTI8907Y6X
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.4da914d0-629e-4766-b57f-6119fa8283cf2026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.677c90cd-6527-40cb-a564-571796513fcb2026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
unii: UTI8907Y6X
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.1afd0016-d0ee-4e25-a1a4-b66f228e2f9c2026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
unii: UTI8907Y6X
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDECardinal Health 107, LLC7e5e76cf-2fda-4f9d-bcbf-f77b1f188ee62026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
rxcui: 312941
unii: UTI8907Y6X
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
SertralineSERTRALINEPreferred Pharmaceuticals Inc.957ba196-0b9b-4cda-bd15-28357ced8d2f2026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
unii: UTI8907Y6X
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Sertraline HClSERTRALINE HYDROCHLORIDEUmedica Laboratories USA Inc.a6d0f35c-f4f4-456d-b8d9-d56297261ad62026-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X

Reported adverse events (FAERS/openFDA)#

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