FDA.reportPublic FDA data

Quetiapine fumarate

Product NDC
67046-638
11-digit product format
670460638
Labeler code
67046
Product ID
67046-638_5a19e429-21d1-efd1-e053-2a91aa0acb63
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
quetiapine
Dosage form
TABLET
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA201109
Marketing category
ANDA
Marketing start
2017-09-26
Marketing end
0000-00-00
Substance
QUETIAPINE FUMARATE
Active strength
300 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
67046-638-072022-01-28C16284748780-1d6a99b39-68ad-a426-e053-dadaa90af4c2636 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
67046-638-142022-01-28C16284748780-1d6a99b39-68ad-a426-e053-dadaa90af4c2636 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
67046-638-152022-01-28C16284748780-1d6a99b39-68ad-a426-e053-dadaa90af4c2636 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
67046-638-202022-01-28C16284748780-1d6a99b39-68ad-a426-e053-dadaa90af4c2636 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
67046-638-212022-01-28C16284748780-1d6a99b39-68ad-a426-e053-dadaa90af4c2636 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
67046-638-282022-01-28C16284748780-1d6a99b39-68ad-a426-e053-dadaa90af4c2636 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
67046-638-302022-01-28C16284748780-1d6a99b39-68ad-a426-e053-dadaa90af4c2636 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
67046-638-602022-01-28C16284748780-1d6a99b39-68ad-a426-e053-dadaa90af4c2636 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
67046-638-07Quetiapine fumarate7 in 1 BLISTER PACKTABLET71
67046-638-14Quetiapine fumarate14 in 1 BLISTER PACKTABLET141
67046-638-15Quetiapine fumarate15 in 1 BLISTER PACKTABLET151
67046-638-20Quetiapine fumarate20 in 1 BLISTER PACKTABLET201
67046-638-21Quetiapine fumarate21 in 1 BLISTER PACKTABLET211
67046-638-28Quetiapine fumarate28 in 1 BLISTER PACKTABLET281
67046-638-30Quetiapine fumarate30 in 1 BLISTER PACKTABLET301
67046-638-60Quetiapine fumarate60 in 1 BLISTER PACKTABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-638QUETIAPINE FUMARATE (QUETIAPINE) TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 8 package rows20170926_5a19e429-21d0-efd1-e053-2a91aa0acb63.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312743QUEtiapine fumarate 100 MG Oral TabletPSN5a19e429-21d0-efd1-e053-2a91aa0acb631
317174QUEtiapine fumarate 200 MG Oral TabletPSN5a19e429-21d0-efd1-e053-2a91aa0acb631
312745QUEtiapine fumarate 300 MG Oral TabletPSN5a19e429-21d0-efd1-e053-2a91aa0acb631
312743quetiapine 100 MG Oral TabletSCD5a19e429-21d0-efd1-e053-2a91aa0acb631
317174quetiapine 200 MG Oral TabletSCD5a19e429-21d0-efd1-e053-2a91aa0acb631
312745quetiapine 300 MG Oral TabletSCD5a19e429-21d0-efd1-e053-2a91aa0acb631
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY5a19e429-21d0-efd1-e053-2a91aa0acb631
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY5a19e429-21d0-efd1-e053-2a91aa0acb631
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSY5a19e429-21d0-efd1-e053-2a91aa0acb631

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67046-638-07670460638077 TABLET in 1 BLISTER PACK (67046-638-07) 7 tablet2017-09-260000-00-00NoNoCurrent
67046-638-146704606381414 TABLET in 1 BLISTER PACK (67046-638-14) 14 tablet2017-09-260000-00-00NoNoCurrent
67046-638-156704606381515 TABLET in 1 BLISTER PACK (67046-638-15) 15 tablet2017-09-260000-00-00NoNoCurrent
67046-638-206704606382020 TABLET in 1 BLISTER PACK (67046-638-20) 20 tablet2017-09-260000-00-00NoNoCurrent
67046-638-216704606382121 TABLET in 1 BLISTER PACK (67046-638-21) 21 tablet2017-09-260000-00-00NoNoCurrent
67046-638-286704606382828 TABLET in 1 BLISTER PACK (67046-638-28) 28 tablet2017-09-260000-00-00NoNoCurrent
67046-638-306704606383030 TABLET in 1 BLISTER PACK (67046-638-30) 30 tablet2017-09-260000-00-00NoNoCurrent
67046-638-606704606386060 TABLET in 1 BLISTER PACK (67046-638-60) 60 tablet2017-09-260000-00-00NoNoCurrent