FDA.reportPublic FDA data

NDC 73309-021 - Sertraline HCl

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
73309-021
Package NDCs from labels
73309-021-01
Manufacturer
BLUEBAY SHANDONG CO.,LTD
Effective date
2019-08-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sertraline HCl - BLUEBAY SHANDONG CO.,LTDBLUEBAY SHANDONG CO.,LTD2019-08-22BULK INGREDIENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73309-021-01Sertraline HCl100 g in 1 JARPOWDER1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73309-021SERTRALINE HCL POWDER [BLUEBAY SHANDONG CO.,LTD]11 package rows20190823_9f87117a-0a0b-47c5-b7be-4c6570ef07a4.zip

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 · 158 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEScieGen Pharmaceuticals Inc10b9cae4-b452-4abb-866a-9f9d2568f2122023-11-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions286b429d-62b9-4ca8-a243-de3f619315bf2023-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
sertraline HClSERTRALINE HYDROCHLORIDEAlmatica Pharma LLC8c8bcba9-eaeb-aa44-f9ea-b580de55a4392023-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
ZoloftSERTRALINE HYDROCHLORIDEViatris Specialty LLCfda754f6-d0f3-4dce-a17a-927d64f912f72023-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEXLCare Pharmaceuticals, Inc.5b73a90e-b883-419b-b30f-a379eed764d92023-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEA-S Medication Solutions14c4fa96-8919-4ea7-ad72-129f288d8cfc2023-05-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions513ecb5b-062f-455f-b798-1c9a54222ff32023-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEProficient Rx LP0f264823-1cba-4478-aef1-a8587f221dbb2022-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
SertralineSERTRALINEProficient Rx LP35dea1a2-ec26-4e52-8f09-ee4678e779462022-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC68c94fb4-3018-44af-b982-2b4b6d461e6f2022-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEProficient Rx LPba201164-f6f7-4779-87a3-62780f3321132022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEProficient Rx LPa0b4b9c9-bd5b-4900-8abf-b55d3283c53c2022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEAscent Pharmaceuticals, Inc.056191ca-999a-4c9b-93b9-64db44b8e6282021-05-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCe815c67d-951c-4cb3-a840-f0b493b97da12020-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEProficient Rx LP787a683a-091c-4908-a643-ecbc8fd467eb2020-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEProficient Rx LP00179766-980b-44b0-99d3-1fee2bb27e372019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEProficient Rx LP551d5946-00df-4608-96a2-b29f0ef93ba02019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEProficient Rx LP6b532e6a-b040-4a10-a242-fb6d8dfc08522019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X

Reported adverse events (FAERS/openFDA)#

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