FDA.reportPublic FDA data

Quetiapine fumarate

Product NDC
67046-632
11-digit product format
670460632
Labeler code
67046
Product ID
67046-632_5abd1db3-4f3b-2359-e053-2a91aa0a1a43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
quetiapine fumarate
Dosage form
TABLET
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA201109
Marketing category
ANDA
Marketing start
2017-10-04
Marketing end
0000-00-00
Substance
QUETIAPINE FUMARATE
Active strength
100 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ef42f82-f087-0d2c-105f-f791ca69210eProduct name820250729
21205abd-8c89-4943-9f85-908f3d4fc3bbProduct name520230501

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67046-632-072022-01-28C16284748780-1d6a99b39-b6fd-a426-e053-dadaa90af4c2632 Quetiapine 100 mg These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997
67046-632-142022-01-28C16284748780-1d6a99b39-b6fd-a426-e053-dadaa90af4c2632 Quetiapine 100 mg These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997
67046-632-152022-01-28C16284748780-1d6a99b39-b6fd-a426-e053-dadaa90af4c2632 Quetiapine 100 mg These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997
67046-632-202022-01-28C16284748780-1d6a99b39-b6fd-a426-e053-dadaa90af4c2632 Quetiapine 100 mg These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997
67046-632-212022-01-28C16284748780-1d6a99b39-b6fd-a426-e053-dadaa90af4c2632 Quetiapine 100 mg These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997
67046-632-282022-01-28C16284748780-1d6a99b39-b6fd-a426-e053-dadaa90af4c2632 Quetiapine 100 mg These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997
67046-632-302022-01-28C16284748780-1d6a99b39-b6fd-a426-e053-dadaa90af4c2632 Quetiapine 100 mg These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997
67046-632-602022-01-28C16284748780-1d6a99b39-b6fd-a426-e053-dadaa90af4c2632 Quetiapine 100 mg These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-632-07Quetiapine fumarate7 in 1 BLISTER PACKTABLET71
67046-632-14Quetiapine fumarate14 in 1 BLISTER PACKTABLET141
67046-632-15Quetiapine fumarate15 in 1 BLISTER PACKTABLET151
67046-632-20Quetiapine fumarate20 in 1 BLISTER PACKTABLET201
67046-632-21Quetiapine fumarate21 in 1 BLISTER PACKTABLET211
67046-632-28Quetiapine fumarate28 in 1 BLISTER PACKTABLET281
67046-632-30Quetiapine fumarate30 in 1 BLISTER PACKTABLET301
67046-632-60Quetiapine fumarate60 in 1 BLISTER PACKTABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-632QUETIAPINE FUMARATE TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 8 package rows20171005_5abdd41c-cfe1-d17e-e053-2a91aa0ab9ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312743QUEtiapine fumarate 100 MG Oral TabletPSN5abdd41c-cfe1-d17e-e053-2a91aa0ab9ed1
312743quetiapine 100 MG Oral TabletSCD5abdd41c-cfe1-d17e-e053-2a91aa0ab9ed1
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY5abdd41c-cfe1-d17e-e053-2a91aa0ab9ed1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67046-632-07670460632077 TABLET in 1 BLISTER PACK (67046-632-07) 7 tablet2017-10-040000-00-00NoNoCurrent
67046-632-146704606321414 TABLET in 1 BLISTER PACK (67046-632-14) 14 tablet2017-10-040000-00-00NoNoCurrent
67046-632-156704606321515 TABLET in 1 BLISTER PACK (67046-632-15) 15 tablet2017-10-040000-00-00NoNoCurrent
67046-632-206704606322020 TABLET in 1 BLISTER PACK (67046-632-20) 20 tablet2017-10-040000-00-00NoNoCurrent
67046-632-216704606322121 TABLET in 1 BLISTER PACK (67046-632-21) 21 tablet2017-10-040000-00-00NoNoCurrent
67046-632-286704606322828 TABLET in 1 BLISTER PACK (67046-632-28) 28 tablet2017-10-040000-00-00NoNoCurrent
67046-632-306704606323030 TABLET in 1 BLISTER PACK (67046-632-30) 30 tablet2017-10-040000-00-00NoNoCurrent
67046-632-606704606326060 TABLET in 1 BLISTER PACK (67046-632-60) 60 tablet2017-10-040000-00-00NoNoCurrent