Quetiapine Fumarate

Product NDC
67296-1243
11-digit product format
672961243
Labeler code
67296
Product ID
67296-1243_d6103513-b2b2-1fd0-e053-2995a90a41ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine Fumarate
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA090120
Marketing category
ANDA
Marketing start
2012-03-27
Marketing end
0000-00-00
Substance
QUETIAPINE FUMARATE
Active strength
25 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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
67296-1243-12024-01-30C16284748780-11030e365-264a-111a-e063-dadaa90a10e2520680bd-a1e4-16d7-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1243-1Quetiapine Fumarate14 in 1 BOTTLETABLET143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1243QUETIAPINE FUMARATE TABLET [REDPHARM DRUG, INC.]3Legacy NDC, 1 package rows20220121_520680bd-a1e4-16d7-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312744QUEtiapine fumarate 25 MG Oral TabletPSN520680bd-a1e4-16d7-e054-00144ff8d46c3
312744quetiapine 25 MG Oral TabletSCD520680bd-a1e4-16d7-e054-00144ff8d46c3
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSY520680bd-a1e4-16d7-e054-00144ff8d46c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1243-16729612430114 TABLET in 1 BOTTLE (67296-1243-1) 14 tablet2012-03-270000-00-00NoNoCurrent