FDA.reportPublic FDA data

NDC 80425-0184-03 - 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
80425-0184
Requested NDC
80425-0184-03
Package NDCs from labels
80425-0184-3, 80425-0184-03
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
80425-0184-3Quetiapine Fumarate90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0184QUETIAPINE FUMARATE TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]4Current NDC, Legacy NDC, 1 package rows20250101_d323b6c0-55fa-6caa-e053-2a95a90a3cff.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0184-3EA - Each80425-01841b0838a2-beb6-409e-b522-104ee471457812023-06-06

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 2 of 8 · 147 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QuetiapineQUETIAPINECoupler LLC56052e5c-0b0b-c296-e063-6394a90a5ad62026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312743
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINEUnit Dose Solutions, Inc.55f358e1-9458-b197-e063-6394a90a3f0e2026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 317174
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINE FUMARATEUnit Dose Solutions, Inc.55f574bc-ec55-93e2-e063-6394a90a1d472026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312744
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINEUnit Dose Solutions, Inc.559fdce5-ab3e-0d02-e063-6394a90a7fbd2026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 616487
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINEUnit Dose Solutions, Inc.55a5671b-7771-0adf-e063-6294a90acfa62026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312743
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINE FUMARATESt. Mary's Medical Park Pharmacy36248b77-277c-7d66-e063-6394a90ae1e82026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 317174
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINECoupler LLC544f6e91-e61f-c57a-e063-6294a90af9d12026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312745
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINE FUMARATESt. Mary's Medical Park Pharmacy3624100f-6e3f-a2ad-e063-6294a90a0fc02026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312743
unii: 2S3PL1B6UJ
Quetiapine Extended ReleaseQUETIAPINEREMEDYREPACK INC.995731f7-aace-4140-b699-d6e8975c7c832026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2S3PL1B6UJ
Quetiapine FumarateQUETIAPINE FUMARATEREMEDYREPACK INC.b90390d8-6ebc-48b3-8b4d-6a3ff7d19ef62026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 616483
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINE FUMARATELupin Pharmaceuticals, Inc.a951cd63-d329-47c9-965a-582fa73a07c62026-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 317174
rxcui: 312745
rxcui: 616483
rxcui: 312744
rxcui: 616487
rxcui: 312743
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINE FUMARATESun Pharmaceutical Industries, Inc.ffe52b98-9872-48c1-90fd-8fcd37c3432f2026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 317174
rxcui: 312745
rxcui: 616483
rxcui: 312744
rxcui: 616487
rxcui: 312743
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINECoupler LLC533154bb-a596-c88b-e063-6294a90a89562026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312743
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINECoupler LLC52ba669d-c846-03c2-e063-6394a90ac0f02026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 317174
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINEAmerican Health Packaging9f927ae2-a0ae-4953-99ba-8de59ee5bfca2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 317174
rxcui: 312745
rxcui: 616483
rxcui: 312744
rxcui: 616487
rxcui: 312743
unii: 2S3PL1B6UJ
Quetiapine FumarateQUETIAPINE FUMARATEBryant Ranch Prepack58541ffd-58c3-49aa-ad90-7e91a3c0b7d62026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312743
unii: 2S3PL1B6UJ
Quetiapine FumarateQUETIAPINE FUMARATEBryant Ranch Prepackd3dcfb51-e67d-44dc-9186-4729f6414bf12026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 616487
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINE FUMARATECoupler LLC5074c897-bcf9-7497-e063-6394a90aa7332026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312743
unii: 2S3PL1B6UJ
Quetiapine FumarateQUETIAPINE FUMARATEBryant Ranch Prepackaa0d27fd-569a-4573-b45d-2de5f5a302942026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 317174
unii: 2S3PL1B6UJ
Quetiapine FumarateQUETIAPINE FUMARATEREMEDYREPACK INC.b84e1614-b077-4ea5-8d11-df68f2b926de2026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202674
rxcui: 312744
unii: 2S3PL1B6UJ

Reported adverse events (FAERS/openFDA)#

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