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 5 of 8 · 154 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEA-S Medication Solutions45af84f5-c284-4e82-ad3c-e9b7ab2b81142025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.3ca30f3f-545e-46c5-b56a-73ec48e9647f2025-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077206
rxcui: 312938
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAvPAK40be43b2-649b-0928-e063-6394a90a3b482025-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
rxcui: 312940
rxcui: 312941
unii: UTI8907Y6X
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
unii: UTI8907Y6X
sertraline hydrochlorideSERTRALINE HYDROCHLORIDEAlvogen, Inc.e0e1f35e-114d-bb39-34f1-70208b94ac9e2025-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
SertralineSERTRALINEA-S Medication Solutionsad69cbfe-5b42-4714-a999-77d474e0849d2025-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEBryant Ranch Prepack50d0aef5-ecc7-49b0-964a-53f87058d22a2025-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077206
rxcui: 312941
unii: UTI8907Y6X
SERTRALINESERTRALINEAphena Pharma Solutions - Tennessee, LLC1548faf9-8625-f871-e063-6394a90a931f2025-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDECipla USA Inc.3a3efb5f-b24a-438d-9253-371ff3b5417d2025-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
SertralineSERTRALINEBryant Ranch Prepackc67bc43d-d341-47c6-8b81-a7ad4cdb12072025-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.23f1c8c5-032c-4ea9-beb0-ca3a614ba4b62025-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC30b94d67-0000-a045-e063-6394a90ade322025-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC680890b1-bc45-4f50-9aaf-e730ab515b852025-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077206
rxcui: 312938
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAsclemed USA, Inc.e25a13c3-a173-4cc3-99d3-0be43abbc4982025-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077206
rxcui: 312938
rxcui: 312940
rxcui: 312941
unii: UTI8907Y6X
SertralineSERTRALINENuCare Pharmaceuticals,Inc.0a1f7d44-c339-a4dd-e063-6294a90ac0de2025-02-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
unii: UTI8907Y6X
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDECoupler LLC2ce05049-030f-3e8b-e063-6394a90a48852025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
unii: UTI8907Y6X
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEDIRECT RXab962a5a-fff6-2cf9-e053-2995a90ace0f2025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077206
rxcui: 312938
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.0e5a7b02-3972-47f0-9f49-e958d792beac2025-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077206
rxcui: 312940
unii: UTI8907Y6X
SertralineSERTRALINEBryant Ranch Prepacke0adb991-ec4e-4cd1-b54e-6d8c731a1d592025-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCec1b68d3-ff55-d0a2-e053-2a95a90a2e0b2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077206
rxcui: 312941
unii: UTI8907Y6X

Reported adverse events (FAERS/openFDA)#

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