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 3 of 8 · 158 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEGranules Pharmaceuticals Inc.98960cc1-1d44-4d89-b415-7e250cc762cc2026-04-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
rxcui: 312940
rxcui: 312941
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEBryant Ranch Prepackddbf623f-8b6f-4e8d-87d3-dc890c0ab8752026-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
unii: UTI8907Y6X
SertralineSERTRALINEBryant Ranch Prepack03e1f274-fa9a-4461-b7c9-31ba6428c1072026-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEREMEDYREPACK INC.bdbcb3ce-e424-43eb-9f1a-77eda4dfbdaa2026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
unii: UTI8907Y6X
SertralineSERTRALINEREMEDYREPACK INC.c614be38-cb45-44a1-b78e-0cdfc06916182026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
unii: UTI8907Y6X
SertralineSERTRALINEREMEDYREPACK INC.f515d1e7-5803-4797-b3cc-8dbea85d96e52026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
unii: UTI8907Y6X
SertralineSERTRALINEREMEDYREPACK INC.e1864a7e-44b9-4399-9554-0c18b46fbdd62026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDELegacy Pharmaceutical Packaging, LLCbd86b293-dab9-4d37-95eb-2bffca335d162026-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
rxcui: 312940
rxcui: 312941
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions5f0616f6-433f-45c9-86f4-f802fda5d8912026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
unii: UTI8907Y6X
SertralineSERTRALINEA-S Medication Solutionse46bc887-69e2-4037-be59-6513277d157b2026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEQuallent Pharmaceuticals Health LLC61835f25-bfe4-49ac-9dbf-3d6387866e782026-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
rxcui: 312941
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDECipla USA Inc.cf71d1b9-5ebb-429f-a07f-a87cd168250f2026-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
rxcui: 312940
rxcui: 312941
unii: UTI8907Y6X
Sertraline HClSERTRALINE HYDROCHLORIDEBiocon Pharma Inc.623b9672-b41e-4ec9-b2cc-f5bb383c39ba2026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEZydus Lifesciences Limited96dedceb-81ad-447c-800e-800cf473d4e42026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labsfd92c8d3-17ec-477c-bc25-e5239c8606ac2026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
rxcui: 312940
rxcui: 312941
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEDr. Reddy's Laboratories Inc.0621fe8d-fdee-4d4c-a8e3-97f729472a582026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.48702ef4-21cd-754e-e063-6394a90af24e2026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
unii: UTI8907Y6X
Sertraline HClSERTRALINEAmneal Pharmaceuticals NY LLCa5c49e6e-b8e0-4a75-99e6-b88e323ce6532026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
SertralineSERTRALINEAvPAK10baaffd-061e-d665-e063-6294a90a15942026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
rxcui: 312940
rxcui: 312941
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDECardinal Health 107, LLCfd8a815e-88b7-4bef-9e32-6dbc735711a32026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
rxcui: 312941
unii: UTI8907Y6X

Reported adverse events (FAERS/openFDA)#

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