FDA.reportPublic FDA data

NDC 80425-0310-01 - 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
80425-0310
Requested NDC
80425-0310-01
Package NDCs from labels
80425-0310-1, 80425-0310-2, 80425-0310-3, 80425-0310-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sertraline Hydrochloride - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0310-1Sertraline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
80425-0310-2Sertraline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED602
80425-0310-3Sertraline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0310SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20250102_f8c45a99-18ed-0e1f-e053-6394a90a2d52.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0310-1EA - Each80425-03103bb7f4cc-45e1-4514-bac6-8644acf457b412023-06-06
80425-0310-2EA - Each80425-0310a492b6c3-f540-496d-8959-2ea629ca260012023-06-06
80425-0310-3EA - Each80425-0310fb7f36e9-db06-489b-9226-f5b3e2fb46ae12023-06-06

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 7 of 8 · 154 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.8e105aeb-6e17-a025-e053-2995a90aba772024-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077206
rxcui: 312938
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.8e98ee4c-24df-88ce-e053-2a95a90a67132024-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077206
rxcui: 312941
unii: UTI8907Y6X
SertralineSERTRALINENuCare Pharmaceuticals,Inc.1ac8a624-2292-b7b8-e063-6394a90a165b2024-06-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.7cadc747-5606-8efe-e053-2991aa0a1d8f2024-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.6dd71a5b-1923-54fb-e053-2991aa0a619e2024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077206
rxcui: 312940
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.71224928-685a-355c-e053-2995a90a0a5b2024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077206
rxcui: 312941
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEBryant Ranch Prepack5c6c817e-a555-4f55-837d-94458787fcb62024-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077206
rxcui: 312940
unii: UTI8907Y6X
Sertraline HCLSERTRALINE HCLDirect_Rx1766ea8b-bb88-8bb8-e063-6394a90a032d2024-05-16Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077206
rxcui: 312941
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEBryant Ranch Prepack22c4b114-5f70-4c64-aa7f-b4169729b8472024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEBryant Ranch Prepack9bcef7ef-4e2f-4ab9-9c0f-f4956bfdd71b2024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
unii: UTI8907Y6X
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEBryant Ranch Prepack82a44e20-d0ee-4ed7-9234-24ef4496ac1d2024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAurobindo Pharma Limited01800452-c353-4235-a66a-214048752e742024-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
SERTRALINESERTRALINEAphena Pharma Solutions - Tennessee, LLC7be6a62e-0e85-47c8-8793-b41c51c2557f2024-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAurobindo Pharma Limited39a85db1-9e59-4ab0-9e18-36757f019faa2024-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077206
ndc (product): 65862-013
rxcui: 312938
rxcui: 312940
rxcui: 312941
spl id: 50d67885-52a9-49a4-9f2a-f82749747222
spl set id: 39a85db1-9e59-4ab0-9e18-36757f019faa
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDENorthStar Rx LLC9bc362d4-489c-4e7f-915a-3076ff8d132a2024-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077206
rxcui: 312938
rxcui: 312940
rxcui: 312941
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions75a43476-25e0-44c3-bbab-2160041032d12023-12-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077206
rxcui: 312938
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions626a9271-a268-4194-935d-779377f902f52023-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077206
rxcui: 312941
unii: UTI8907Y6X
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEScieGen Pharmaceuticals Inc10b9cae4-b452-4abb-866a-9f9d2568f2122023-11-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
rxcui: 312940
rxcui: 312941
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions286b429d-62b9-4ca8-a243-de3f619315bf2023-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077206
rxcui: 312938
rxcui: 312940
rxcui: 312941
unii: UTI8907Y6X
ZoloftSERTRALINE HYDROCHLORIDEViatris Specialty LLCfda754f6-d0f3-4dce-a17a-927d64f912f72023-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
rxcui: 312940
rxcui: 312941
unii: UTI8907Y6X

Reported adverse events (FAERS/openFDA)#

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