FDA.reportPublic FDA data

NDC 67046-637-03 - 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
67046-637
Requested NDC
67046-637-03
Package NDCs from labels
67046-637-07, 67046-637-14, 67046-637-15, 67046-637-20, 67046-637-21, 67046-637-60, 67046-637-28, 67046-637-30, 67046-637-03
Manufacturer
Contract Pharmacy Services-PA | Coupler Enterprises Inc.
Effective date
2017-09-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Quetiapine fumarate - Contract Pharmacy Services-PA | Coupler Enterprises Inc.Contract Pharmacy Services-PA | Coupler Enterprises Inc.2017-09-26HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
67046-637-07636 Quetiapine 100 mg 637 Quetiapine 200 mg 638 Quetiapine 300 mg These highlights do not include all the information needed to use Quetiapine Tablets USP safely and effectively. See full prescribing information for Quetiapine Tablets USP. QUETIAPINE Tablets USP, for oral use Initial U.S. Approval: 1997
67046-637-14636 Quetiapine 100 mg 637 Quetiapine 200 mg 638 Quetiapine 300 mg These highlights do not include all the information needed to use Quetiapine Tablets USP safely and effectively. See full prescribing information for Quetiapine Tablets USP. QUETIAPINE Tablets USP, for oral use Initial U.S. Approval: 1997
67046-637-15636 Quetiapine 100 mg 637 Quetiapine 200 mg 638 Quetiapine 300 mg These highlights do not include all the information needed to use Quetiapine Tablets USP safely and effectively. See full prescribing information for Quetiapine Tablets USP. QUETIAPINE Tablets USP, for oral use Initial U.S. Approval: 1997
67046-637-20636 Quetiapine 100 mg 637 Quetiapine 200 mg 638 Quetiapine 300 mg These highlights do not include all the information needed to use Quetiapine Tablets USP safely and effectively. See full prescribing information for Quetiapine Tablets USP. QUETIAPINE Tablets USP, for oral use Initial U.S. Approval: 1997
67046-637-21636 Quetiapine 100 mg 637 Quetiapine 200 mg 638 Quetiapine 300 mg These highlights do not include all the information needed to use Quetiapine Tablets USP safely and effectively. See full prescribing information for Quetiapine Tablets USP. QUETIAPINE Tablets USP, for oral use Initial U.S. Approval: 1997
67046-637-28636 Quetiapine 100 mg 637 Quetiapine 200 mg 638 Quetiapine 300 mg These highlights do not include all the information needed to use Quetiapine Tablets USP safely and effectively. See full prescribing information for Quetiapine Tablets USP. QUETIAPINE Tablets USP, for oral use Initial U.S. Approval: 1997
67046-637-30636 Quetiapine 100 mg 637 Quetiapine 200 mg 638 Quetiapine 300 mg These highlights do not include all the information needed to use Quetiapine Tablets USP safely and effectively. See full prescribing information for Quetiapine Tablets USP. QUETIAPINE Tablets USP, for oral use Initial U.S. Approval: 1997
67046-637-60636 Quetiapine 100 mg 637 Quetiapine 200 mg 638 Quetiapine 300 mg These highlights do not include all the information needed to use Quetiapine Tablets USP safely and effectively. See full prescribing information for Quetiapine Tablets USP. QUETIAPINE Tablets USP, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-637-07Quetiapine fumarate7 in 1 BLISTER PACKTABLET71
67046-637-14Quetiapine fumarate14 in 1 BLISTER PACKTABLET141
67046-637-15Quetiapine fumarate15 in 1 BLISTER PACKTABLET151
67046-637-20Quetiapine fumarate20 in 1 BLISTER PACKTABLET201
67046-637-21Quetiapine fumarate21 in 1 BLISTER PACKTABLET211
67046-637-28Quetiapine fumarate28 in 1 BLISTER PACKTABLET281
67046-637-30Quetiapine fumarate30 in 1 BLISTER PACKTABLET301
67046-637-60Quetiapine fumarate60 in 1 BLISTER PACKTABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-637QUETIAPINE FUMARATE (QUETIAPINE) TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 8 package rows20170926_5a19e429-21d0-efd1-e053-2a91aa0acb63.zip

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 116 · 2,317 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quetiapine fumarateQUETIAPINE FUMARATEREMEDYREPACK INC.c6c454c4-3eae-48ae-bf17-5dccdb6591412026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA201109
rxcui: 616487
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINE FUMARATEREMEDYREPACK INC.d38f0f4e-dc0f-4c92-a212-c4da3db748012026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA201109
unii: 2S3PL1B6UJ
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
unii: 15FIX9V2JP
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
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact identifier
unii: 15FIX9V2JP
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
application number: ANDA201109
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
application number: ANDA201109
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
application number: ANDA201109
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
application number: ANDA201109
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
application number: ANDA201109
rxcui: 616487
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINECoupler LLC5643d339-50ea-405d-e063-6394a90a3b702026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA201109
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