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 5 of 6 · 101 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.71224928-685a-355c-e053-2995a90a0a5b2024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEBryant Ranch Prepack5c6c817e-a555-4f55-837d-94458787fcb62024-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
Sertraline HCLSERTRALINE HCLDirect_Rx1766ea8b-bb88-8bb8-e063-6394a90a032d2024-05-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEBryant Ranch Prepack22c4b114-5f70-4c64-aa7f-b4169729b8472024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEBryant Ranch Prepack82a44e20-d0ee-4ed7-9234-24ef4496ac1d2024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAurobindo Pharma Limited39a85db1-9e59-4ab0-9e18-36757f019faa2024-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
rxcui: 312941
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDENorthStar Rx LLC9bc362d4-489c-4e7f-915a-3076ff8d132a2024-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
rxcui: 312941
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: 312940
rxcui: 312941
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions286b429d-62b9-4ca8-a243-de3f619315bf2023-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
rxcui: 312941
ZoloftSERTRALINE HYDROCHLORIDEViatris Specialty LLCfda754f6-d0f3-4dce-a17a-927d64f912f72023-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
rxcui: 312941
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEXLCare Pharmaceuticals, Inc.5b73a90e-b883-419b-b30f-a379eed764d92023-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
rxcui: 312941
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions513ecb5b-062f-455f-b798-1c9a54222ff32023-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
SertralineSERTRALINEProficient Rx LP35dea1a2-ec26-4e52-8f09-ee4678e779462022-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
rxcui: 312941
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: 312940
rxcui: 312941
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: 312941

Reported adverse events (FAERS/openFDA)#

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