FDA.reportPublic FDA data

NDC 80425-0200-01 - 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
80425-0200
Requested NDC
80425-0200-01
Package NDCs from labels
80425-0200-1, 80425-0200-2, 80425-0200-3, 80425-0200-01
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
80425-0200-1Sertraline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED305
80425-0200-2Sertraline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED605
80425-0200-3Sertraline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0200SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]5Current NDC, Legacy NDC, 3 package rows20250101_ec1b68d3-ff55-d0a2-e053-2a95a90a2e0b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0200-1EA - Each80425-020003ef4d3e-014e-4195-8a56-83f4fc89543b12023-04-07
80425-0200-2EA - Each80425-020081a8962a-db14-4883-b4cf-e50f41204f2012023-06-06
80425-0200-3EA - Each80425-020059e65e04-28a1-446b-9442-df5d1997a83b12023-06-06

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 4 of 8 · 158 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions7f62789b-61df-4b7b-9e01-c7a4dfb7e73c2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077206
rxcui: 312940
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions90524e6e-c34f-43eb-8c30-d99faf7ae08f2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077206
rxcui: 312940
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDENorthwind Health Company, LLCab0b0ef7-155b-cec9-e053-2a95a90a9fce2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077206
rxcui: 312938
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDENorthwind Health Company, LLCab1bb71f-936d-cb40-e053-2a95a90a08bb2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077206
rxcui: 312941
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDENorthwind Health Company, LLCab30b0a4-6696-19da-e053-2995a90a29aa2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions345271ff-6a48-4888-a8d0-5a8ad60c7a212025-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
unii: UTI8907Y6X
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEAccord Healthcare, Inc.205ecf52-8138-44a7-ad9a-b3aa7f4fa11a2025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
rxcui: 312940
rxcui: 312941
unii: UTI8907Y6X
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEQPharma, Inc.dc97a895-8c2f-4891-85f3-7f45e23961402025-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEQPharma Inc664d1744-7b1d-43e2-98ba-1b0e69d758402025-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077206
rxcui: 312941
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAurobindo Pharma Limitedb497dfeb-a48c-4f2a-b309-b56f3a26a19b2025-11-24Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077206
rxcui: 312938
rxcui: 312940
rxcui: 312941
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEBryant Ranch Prepackb400fed8-f425-47ff-ab42-915cb6e7f1522025-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077206
rxcui: 312941
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.8f5a71b2-2821-46a0-ac65-28d9b2db73ec2025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077206
rxcui: 312940
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions0de9e3e3-912a-428b-89d2-70811a56cdc52025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions1b069fd8-26b9-459e-abfb-de28c012ddcb2025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutionsa06f2cf6-ccef-47bf-aba8-a42bada46d8b2025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions473d6055-b811-4ffb-9398-88f50a1521962025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDELupin Pharmaceuticals, Inc.42120ff8-b353-4632-9ea9-54de9a6987242025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
rxcui: 312940
rxcui: 312941
unii: UTI8907Y6X
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEA-S Medication Solutions2bb3a2d1-76c4-42e6-8553-aa95f263175b2025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
unii: UTI8907Y6X
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEA-S Medication Solutionsc0cc1b03-ba35-4a2c-be95-2d9b7f4c34992025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
unii: UTI8907Y6X
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEA-S Medication Solutions50b54bfa-0b90-44f1-8f73-4f7f552449c42025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
unii: UTI8907Y6X

Reported adverse events (FAERS/openFDA)#

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