FDA.reportPublic FDA data

Quetiapine

Product NDC
67046-620
11-digit product format
670460620
Labeler code
67046
Product ID
67046-620_5a1a6ce6-741e-6941-e053-2a91aa0a83e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA202152
Marketing category
ANDA
Marketing start
2017-09-26
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
2019-12-31
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
67046-620-072020-01-31C16284748780-19d75b9d0-b848-f424-e053-dadaa90a57ce620 Quetiapine 100 mg 621 Quetiapine 200 mg 622 Quetiapine 300 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
67046-620-142020-01-31C16284748780-19d75b9d0-b848-f424-e053-dadaa90a57ce620 Quetiapine 100 mg 621 Quetiapine 200 mg 622 Quetiapine 300 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
67046-620-152020-01-31C16284748780-19d75b9d0-b848-f424-e053-dadaa90a57ce620 Quetiapine 100 mg 621 Quetiapine 200 mg 622 Quetiapine 300 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
67046-620-202020-01-31C16284748780-19d75b9d0-b848-f424-e053-dadaa90a57ce620 Quetiapine 100 mg 621 Quetiapine 200 mg 622 Quetiapine 300 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
67046-620-212020-01-31C16284748780-19d75b9d0-b848-f424-e053-dadaa90a57ce620 Quetiapine 100 mg 621 Quetiapine 200 mg 622 Quetiapine 300 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
67046-620-282020-01-31C16284748780-19d75b9d0-b848-f424-e053-dadaa90a57ce620 Quetiapine 100 mg 621 Quetiapine 200 mg 622 Quetiapine 300 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
67046-620-302020-01-31C16284748780-19d75b9d0-b848-f424-e053-dadaa90a57ce620 Quetiapine 100 mg 621 Quetiapine 200 mg 622 Quetiapine 300 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
67046-620-602020-01-31C16284748780-19d75b9d0-b848-f424-e053-dadaa90a57ce620 Quetiapine 100 mg 621 Quetiapine 200 mg 622 Quetiapine 300 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
67046-620-07Quetiapine7 in 1 BLISTER PACKTABLET, FILM COATED71
67046-620-14Quetiapine14 in 1 BLISTER PACKTABLET, FILM COATED141
67046-620-15Quetiapine15 in 1 BLISTER PACKTABLET, FILM COATED151
67046-620-20Quetiapine20 in 1 BLISTER PACKTABLET, FILM COATED201
67046-620-21Quetiapine21 in 1 BLISTER PACKTABLET, FILM COATED211
67046-620-28Quetiapine28 in 1 BLISTER PACKTABLET, FILM COATED281
67046-620-30Quetiapine30 in 1 BLISTER PACKTABLET, FILM COATED301
67046-620-60Quetiapine60 in 1 BLISTER PACKTABLET, FILM COATED601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-620QUETIAPINE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 8 package rows20170926_5a1a6ce6-741d-6941-e053-2a91aa0a83e7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312743QUEtiapine fumarate 100 MG Oral TabletPSN5a1a6ce6-741d-6941-e053-2a91aa0a83e71
317174QUEtiapine fumarate 200 MG Oral TabletPSN5a1a6ce6-741d-6941-e053-2a91aa0a83e71
312745QUEtiapine fumarate 300 MG Oral TabletPSN5a1a6ce6-741d-6941-e053-2a91aa0a83e71
312743quetiapine 100 MG Oral TabletSCD5a1a6ce6-741d-6941-e053-2a91aa0a83e71
317174quetiapine 200 MG Oral TabletSCD5a1a6ce6-741d-6941-e053-2a91aa0a83e71
312745quetiapine 300 MG Oral TabletSCD5a1a6ce6-741d-6941-e053-2a91aa0a83e71
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY5a1a6ce6-741d-6941-e053-2a91aa0a83e71
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY5a1a6ce6-741d-6941-e053-2a91aa0a83e71
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSY5a1a6ce6-741d-6941-e053-2a91aa0a83e71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67046-620-07670460620077 in 1 BLISTER PACKHistorical
67046-620-146704606201414 in 1 BLISTER PACKHistorical
67046-620-156704606201515 in 1 BLISTER PACKHistorical
67046-620-206704606202020 in 1 BLISTER PACKHistorical
67046-620-216704606202121 in 1 BLISTER PACKHistorical
67046-620-286704606202828 in 1 BLISTER PACKHistorical
67046-620-306704606203030 in 1 BLISTER PACKHistorical
67046-620-606704606206060 in 1 BLISTER PACKHistorical