NDC 0228-2722 - 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
0228-2722
Package NDCs from labels
0228-2722-03, 0228-2722-09, 0228-2722-90
Manufacturer
Actavis Elizabeth LLC
Effective date
2009-04-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sertraline Hydrochloride - Actavis Elizabeth LLCActavis Elizabeth LLC2009-04-07HUMAN PRESCRIPTION DRUG LABELING

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0228-2722SERTRALINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]1Unmatched20090626_A9A68BF7-9C81-4517-870A-E93BD0E4F45C.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sertraline HydrochlorideACTIVE INGREDIENTUTI8907Y6XSERTRALINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]1
sertralineACTIVE MOIETYQUC7NX6WMBSERTRALINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]1
d&c red #27 phloxine aluminum lakeINACTIVE INGREDIENTSERTRALINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]1
dibasic calcium phosphate dihydrateINACTIVE INGREDIENTO7TSZ97GEPSERTRALINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]1
fd&c blue #1 brilliant blue fcf aluminum lakeINACTIVE INGREDIENTSERTRALINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]1
fd&c red #40 allura red ac aluminum lakeINACTIVE INGREDIENTSERTRALINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]1
fd&c yellow #6 aluminum lakeINACTIVE INGREDIENTSERTRALINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]1
hypromelloseINACTIVE INGREDIENT3NXW29V3WOSERTRALINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]1
magnesium stearateINACTIVE INGREDIENT70097M6I30SERTRALINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]1
microcrystalline celluoseINACTIVE INGREDIENTSERTRALINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]1
polydextroseINACTIVE INGREDIENTVH2XOU12IESERTRALINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]1
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1ASERTRALINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]1
sodium starch glycolateINACTIVE INGREDIENTSERTRALINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPSERTRALINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]1
triacetinINACTIVE INGREDIENTXHX3C3X673SERTRALINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]1

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 6 · 101 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEBryant Ranch Prepack50d0aef5-ecc7-49b0-964a-53f87058d22a2025-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
SERTRALINESERTRALINEAphena Pharma Solutions - Tennessee, LLC1548faf9-8625-f871-e063-6394a90a931f2025-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
SertralineSERTRALINEBryant Ranch Prepackc67bc43d-d341-47c6-8b81-a7ad4cdb12072025-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAsclemed USA, Inc.e25a13c3-a173-4cc3-99d3-0be43abbc4982025-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
rxcui: 312941
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDECoupler LLC2ce05049-030f-3e8b-e063-6394a90a48852025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.0e5a7b02-3972-47f0-9f49-e958d792beac2025-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ae3be25b-2bde-4142-ad56-920a96ac8f392025-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCec1b68d3-ff55-d0a2-e053-2a95a90a2e0b2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
SertralineSERTRALINEQuality Care Products, LLC6ed2b9b7-e4af-4e28-a7d5-4ccb514af2172024-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAmerican Health Packaging4e09f580-d612-416c-a4a4-79a4411845b22024-11-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
rxcui: 312941
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutionsf705f743-40e9-42bf-88f5-6dd7e5d5ba942024-10-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions4f6f2412-8085-45bf-be4f-63e44490a34e2024-10-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
SertralineSERTRALINEA-S Medication Solutionse93391c9-db88-4fa5-b1d5-f6c6de78b31c2024-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEBryant Ranch Prepack4191b929-5bdb-4388-9e4d-fffce55bc3632024-10-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDECamber Pharmaceuticals, Inc.de1f85ac-df1b-4b7b-8e18-48ebdc8b92792024-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
rxcui: 312941
SertralineSERTRALINEA-S Medication Solutionscbc2bd3b-03fc-47b9-91d1-8989ec90c7e62024-08-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEBryant Ranch Prepackc6897cf2-1349-400d-ab22-1e88f097b6932024-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.8e98ee4c-24df-88ce-e053-2a95a90a67132024-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
SertralineSERTRALINENuCare Pharmaceuticals,Inc.1ac8a624-2292-b7b8-e063-6394a90a165b2024-06-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.6dd71a5b-1923-54fb-e053-2991aa0a619e2024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940

Reported adverse events (FAERS/openFDA)#

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