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 8 of 8 · 144 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEProficient Rx LP00179766-980b-44b0-99d3-1fee2bb27e372019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEProficient Rx LP551d5946-00df-4608-96a2-b29f0ef93ba02019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEProficient Rx LP6b532e6a-b040-4a10-a242-fb6d8dfc08522019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
rxcui: 312941
B1BB1367-2E16-CDC8-0E5E-F125D6876BEFA8B2AD71-CFDC-4A29-8194-DEEFEA138B162008-05-16Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: B1BB1367-2E16-CDC8-0E5E-F125D6876BEF
spl set id: A8B2AD71-CFDC-4A29-8194-DEEFEA138B16

Reported adverse events (FAERS/openFDA)#

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