FDA.reportPublic FDA data

NDC 80425-0186-03 - Quetiapine Fumarate

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
80425-0186
Requested NDC
80425-0186-03
Package NDCs from labels
80425-0186-3, 80425-0186-03
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
Quetiapine Fumarate - 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
80425-0186-3Quetiapine Fumarate90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0186QUETIAPINE FUMARATE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]4Current NDC, Legacy NDC, 1 package rows20250101_d2a76aed-a0b8-33f0-e053-2a95a90add0f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0186-3EA - Each80425-0186adfc935b-bd2b-49a8-9d50-58188005455812023-06-06

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 1 of 8 · 147 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quetiapine fumarateQUETIAPINE FUMARATEPreferred Pharmaceuticals Inc.711f42c5-0719-46de-81fb-3d03801b9ed92026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 317174
rxcui: 312743
unii: 2S3PL1B6UJ
Quetiapine FumarateQUETIAPINE FUMARATEPreferred Pharmaceuticals Inc.717b55c4-a23f-4d74-8023-0f4e14d89ec82026-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA201504
rxcui: 616487
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINE FUMARATENuCare Pharmaceuticals,Inc.227b8b2b-a238-efb4-e063-6394a90acc7e2026-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312744
unii: 2S3PL1B6UJ
QuetiapineQUETIAPINEAscend Laboratories, LLC3112a006-1c61-47f2-84f5-9a7670d09c9b2026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA201504
ndc (product): 67877-249
rxcui: 317174
rxcui: 312745
rxcui: 616483
rxcui: 389201
rxcui: 312744
rxcui: 616487
rxcui: 312743
spl id: 1324eb95-6488-498f-b2c9-1c44b1f48062
spl set id: 3112a006-1c61-47f2-84f5-9a7670d09c9b
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINE FUMARATEREMEDYREPACK INC.c6c454c4-3eae-48ae-bf17-5dccdb6591412026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 616487
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINE FUMARATEREMEDYREPACK INC.d38f0f4e-dc0f-4c92-a212-c4da3db748012026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 616483
unii: 2S3PL1B6UJ
Quetiapine FumarateQUETIAPINE FUMARATEREMEDYREPACK INC.3085f68d-e83c-4f59-b058-8bdae7f4e5372026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312743
unii: 2S3PL1B6UJ
Quetiapine FumarateQUETIAPINE FUMARATEREMEDYREPACK INC.b8864cb9-1c6a-4e36-9893-eb1403ee87452026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312744
unii: 2S3PL1B6UJ
QUETIAPINEQUETIAPINEREMEDYREPACK INC.90da6c48-3282-41dc-b4fa-75d33efa9fee2026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINE FUMARATEREMEDYREPACK INC.ea9b9ed1-4be0-4dc0-b1dd-239caff5253e2026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312743
unii: 2S3PL1B6UJ
QuetiapineQUETIAPINEMajor Pharmaceuticalsb02324b1-e7f0-4cbc-8778-5f7c4a5d194a2026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINE FUMARATEREMEDYREPACK INC.02b19885-2987-4c46-8d2a-5e59656f72e82026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 317174
unii: 2S3PL1B6UJ
QUETIAPINEQUETIAPINEREMEDYREPACK INC.67872105-4ec6-4d46-b3b4-c672c93576d22026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINE FUMARATEREMEDYREPACK INC.695415b1-083d-4540-9f41-bde4b201f8342026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312745
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINE FUMARATEBryant Ranch Prepackc52a9bff-8a03-44f5-9128-799c7dca04672026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 317174
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINE FUMARATEBryant Ranch Prepack94a81681-381e-4b3b-89ac-e86dcbe7f8902026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312745
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINE FUMARATEBryant Ranch Prepack3eb39b4e-4c79-43b9-a30e-b4221c0e2bd22026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 616487
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINE FUMARATEBryant Ranch Prepackfd9cce28-0052-4b0b-8a66-a1615e082d952026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 616487
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINECoupler LLC5643d339-50ea-405d-e063-6394a90a3b702026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312744
unii: 2S3PL1B6UJ
Quetiapine FumarateQUETIAPINE FUMARATENorthStar Rx LLCe6e25ef9-2671-489e-8eca-58bedb4f59ab2026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 317174
rxcui: 312745
rxcui: 616483
rxcui: 312744
rxcui: 616487
rxcui: 312743
unii: 2S3PL1B6UJ

Reported adverse events (FAERS/openFDA)#

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