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 6 of 8 · 158 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ae3be25b-2bde-4142-ad56-920a96ac8f392025-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077206
rxcui: 312941
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
ndc (package): 80425-0200-1
ndc (package): 80425-0200-3
ndc (package): 80425-0200-2
ndc (product): 80425-0200
ndc11 (package): 80425020001
rxcui: 312941
spl id: 2a99bd40-3c53-3207-e063-6294a90a4faa
spl set id: ec1b68d3-ff55-d0a2-e053-2a95a90a2e0b
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf8c45a99-18ed-0e1f-e053-6394a90a2d522024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077206
rxcui: 312938
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEQuality Care Products LLC25aef6c1-9964-44a1-a905-c37e5c28a3c02024-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077206
rxcui: 312938
unii: UTI8907Y6X
SertralineSERTRALINEQuality Care Products, LLC6ed2b9b7-e4af-4e28-a7d5-4ccb514af2172024-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAmerican Health Packaging4e09f580-d612-416c-a4a4-79a4411845b22024-11-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
rxcui: 312940
rxcui: 312941
unii: UTI8907Y6X
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutionsf705f743-40e9-42bf-88f5-6dd7e5d5ba942024-10-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
unii: UTI8907Y6X
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions4f6f2412-8085-45bf-be4f-63e44490a34e2024-10-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
unii: UTI8907Y6X
SertralineSERTRALINEA-S Medication Solutionse93391c9-db88-4fa5-b1d5-f6c6de78b31c2024-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEBryant Ranch Prepack9f1d5689-3bf1-431c-9ea2-9e37217ecf402024-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077206
rxcui: 312938
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEBryant Ranch Prepack4191b929-5bdb-4388-9e4d-fffce55bc3632024-10-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077206
rxcui: 312941
unii: UTI8907Y6X
SertralineSERTRALINEA-S Medication Solutionsf5bf9595-d9f9-40b1-9b3b-da277fd5ab7f2024-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
unii: UTI8907Y6X
SertralineSERTRALINEA-S Medication Solutionsb2533b60-cc54-4905-a4ee-ea08a160f8c62024-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
unii: UTI8907Y6X
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEMylan Pharmaceuticals Inc.1a58062b-e635-431a-908d-2651c6a4a21c2024-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDECamber Pharmaceuticals, Inc.de1f85ac-df1b-4b7b-8e18-48ebdc8b92792024-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
rxcui: 312940
rxcui: 312941
unii: UTI8907Y6X
SertralineSERTRALINEA-S Medication Solutionscbc2bd3b-03fc-47b9-91d1-8989ec90c7e62024-08-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
unii: UTI8907Y6X
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEBryant Ranch Prepackfa260c6c-9f6a-46a3-91ce-5665739d87e72024-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDENorthStar Rx LLC7f144b68-ae90-483c-b030-f6824662a7342024-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEBryant Ranch Prepackc6897cf2-1349-400d-ab22-1e88f097b6932024-08-08Boxed 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.