FDA.reportPublic FDA data

NDC 0591-3239 - 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
0591-3239
Package NDCs from labels
0591-3239-30, 0591-3239-19, 0591-3239-10
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
0591-3239-10Sertraline Hydrochloride1000 in 1 BOTTLETABLET10002
0591-3239-19Sertraline Hydrochloride90 in 1 BOTTLETABLET902
0591-3239-30Sertraline Hydrochloride30 in 1 BOTTLETABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-3239SERTRALINE 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 4 of 8 · 144 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions345271ff-6a48-4888-a8d0-5a8ad60c7a212025-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEAccord Healthcare, Inc.205ecf52-8138-44a7-ad9a-b3aa7f4fa11a2025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
rxcui: 312940
rxcui: 312941
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEQPharma, Inc.dc97a895-8c2f-4891-85f3-7f45e23961402025-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEQPharma Inc664d1744-7b1d-43e2-98ba-1b0e69d758402025-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAurobindo Pharma Limitedb497dfeb-a48c-4f2a-b309-b56f3a26a19b2025-11-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
rxcui: 312940
rxcui: 312941
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEBryant Ranch Prepackb400fed8-f425-47ff-ab42-915cb6e7f1522025-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.8f5a71b2-2821-46a0-ac65-28d9b2db73ec2025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions0de9e3e3-912a-428b-89d2-70811a56cdc52025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions1b069fd8-26b9-459e-abfb-de28c012ddcb2025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutionsa06f2cf6-ccef-47bf-aba8-a42bada46d8b2025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions473d6055-b811-4ffb-9398-88f50a1521962025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDELupin Pharmaceuticals, Inc.42120ff8-b353-4632-9ea9-54de9a6987242025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
rxcui: 312940
rxcui: 312941
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEA-S Medication Solutions2bb3a2d1-76c4-42e6-8553-aa95f263175b2025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEA-S Medication Solutionsc0cc1b03-ba35-4a2c-be95-2d9b7f4c34992025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEA-S Medication Solutions50b54bfa-0b90-44f1-8f73-4f7f552449c42025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEA-S Medication Solutions45af84f5-c284-4e82-ad3c-e9b7ab2b81142025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.3ca30f3f-545e-46c5-b56a-73ec48e9647f2025-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAvPAK40be43b2-649b-0928-e063-6394a90a3b482025-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
rxcui: 312940
rxcui: 312941
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.91b4c802-9c6b-49bb-b5a7-661e1917ef342025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
SertralineSERTRALINEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.444ca054-e450-4c10-a31b-71ad43946cb82025-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
rxcui: 312940
rxcui: 312941

Reported adverse events (FAERS/openFDA)#

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