FDA.reportPublic FDA data

NDC 0591-3240 - 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
0591-3240
Package NDCs from labels
0591-3240-30, 0591-3240-19, 0591-3240-10
Manufacturer
Watson Laboratories, Inc.
Effective date
2008-05-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sertraline Hydrochloride Tablets Revised: August 2007 Rx onlyWatson Laboratories, Inc.2008-05-16HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-3240-10Sertraline Hydrochloride1000 in 1 BOTTLETABLET10002
0591-3240-19Sertraline Hydrochloride90 in 1 BOTTLETABLET902
0591-3240-30Sertraline Hydrochloride30 in 1 BOTTLETABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-3240SERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]23 package rows20080710_A8B2AD71-CFDC-4A29-8194-DEEFEA138B16.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sertraline HydrochlorideACTIVE INGREDIENTUTI8907Y6XSERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]2
SertralineACTIVE MOIETYQUC7NX6WMBSERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]2
corn starchINACTIVE INGREDIENTSERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]2
D&C yellow no. 10 aluminum lakeINACTIVE INGREDIENTSERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]2
FD&C blue no. 2 aluminum lakeINACTIVE INGREDIENTSERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]2
FD&C yellow no. 6 aluminum lakeINACTIVE INGREDIENTSERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]2
hypromelloseINACTIVE INGREDIENTSERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]2
iron oxide yellowINACTIVE INGREDIENTEX438O2MRTSERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30SERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]2
microcrystalline celluloseINACTIVE INGREDIENTSERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]2
polyethylene glycolINACTIVE INGREDIENTSERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]2
sodium starch glycolateINACTIVE INGREDIENTSERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPSERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]2

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 7 of 8 · 144 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEBryant Ranch Prepack82a44e20-d0ee-4ed7-9234-24ef4496ac1d2024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
SERTRALINESERTRALINEAphena Pharma Solutions - Tennessee, LLC7be6a62e-0e85-47c8-8793-b41c51c2557f2024-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAurobindo Pharma Limited39a85db1-9e59-4ab0-9e18-36757f019faa2024-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
rxcui: 312940
rxcui: 312941
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDENorthStar Rx LLC9bc362d4-489c-4e7f-915a-3076ff8d132a2024-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
rxcui: 312940
rxcui: 312941
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions75a43476-25e0-44c3-bbab-2160041032d12023-12-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions626a9271-a268-4194-935d-779377f902f52023-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEScieGen Pharmaceuticals Inc10b9cae4-b452-4abb-866a-9f9d2568f2122023-11-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
rxcui: 312940
rxcui: 312941
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions286b429d-62b9-4ca8-a243-de3f619315bf2023-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
rxcui: 312940
rxcui: 312941
ZoloftSERTRALINE HYDROCHLORIDEViatris Specialty LLCfda754f6-d0f3-4dce-a17a-927d64f912f72023-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
rxcui: 312940
rxcui: 312941
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEXLCare Pharmaceuticals, Inc.5b73a90e-b883-419b-b30f-a379eed764d92023-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
rxcui: 312940
rxcui: 312941
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEA-S Medication Solutions14c4fa96-8919-4ea7-ad72-129f288d8cfc2023-05-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions513ecb5b-062f-455f-b798-1c9a54222ff32023-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEProficient Rx LP0f264823-1cba-4478-aef1-a8587f221dbb2022-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
SertralineSERTRALINEProficient Rx LP35dea1a2-ec26-4e52-8f09-ee4678e779462022-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
rxcui: 312940
rxcui: 312941
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC68c94fb4-3018-44af-b982-2b4b6d461e6f2022-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEProficient Rx LPba201164-f6f7-4779-87a3-62780f3321132022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEProficient Rx LPa0b4b9c9-bd5b-4900-8abf-b55d3283c53c2022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEAscent Pharmaceuticals, Inc.056191ca-999a-4c9b-93b9-64db44b8e6282021-05-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
rxcui: 312940
rxcui: 312941
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCe815c67d-951c-4cb3-a840-f0b493b97da12020-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEProficient Rx LP787a683a-091c-4908-a643-ecbc8fd467eb2020-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938

Reported adverse events (FAERS/openFDA)#

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