FDA.reportPublic FDA data

NDC 68071-4494-06 - Sertraline Hydrochloride

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
68071-4494
Requested NDC
68071-4494-06
Package NDCs from labels
68071-4494-2, 68071-4494-3, 68071-4494-8, 68071-4494-5, 68071-4494-6, 68071-4494-9, 68071-4494-06
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-06-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sertraline Hydrochloride - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2024-06-10HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68071-4494-22021-02-17These 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
68071-4494-32021-02-17These 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
68071-4494-52021-02-17These 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
68071-4494-62021-02-17These 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
68071-4494-82021-02-17These 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
68071-4494-92021-02-17These 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
68071-4494-22021-01-29These 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
68071-4494-32021-01-29These 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
68071-4494-52021-01-29These 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
68071-4494-62021-01-29These 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
68071-4494-82021-01-29These 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
68071-4494-92021-01-29These 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
68071-4494-2Sertraline Hydrochloride20 in 1 BOTTLETABLET, FILM COATED206
68071-4494-3Sertraline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED306
68071-4494-5Sertraline Hydrochloride56 in 1 BOTTLETABLET, FILM COATED566
68071-4494-6Sertraline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED606
68071-4494-8Sertraline Hydrochloride28 in 1 BOTTLETABLET, FILM COATED286
68071-4494-9Sertraline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4494SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]6Current NDC, Legacy NDC, 6 package rows20240612_71224928-685a-355c-e053-2995a90a0a5b.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 116 · 2,311 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
Dr.Harry EYES PROTECTIONPOLYETHYLENE GLYCOL 400 1% EYES PROTECTIONWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9fe033-89d3-da62-e063-6294a90a45032026-09-03WarningsExact identifier
unii: B697894SGQ
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
application number: ANDA077206
rxcui: 312940
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.5921f77f-01a2-40b9-ad77-2258865c997d2026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077206
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
application number: ANDA077206
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 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.