FDA.reportPublic FDA data

Quetiapine

Product NDC
10135-657
11-digit product format
101350657
Labeler code
10135
Product ID
10135-657_6fd3392c-0934-402e-8b1a-75b2b9ca9d95
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA209635
Marketing category
ANDA
Marketing start
2018-05-01
Marketing end
0000-00-00
Substance
QUETIAPINE FUMARATE
Active strength
200 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
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
10135-657-602022-01-28C16284748780-19d75b9d0-d537-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use QUETIAPINE EXT ENDED-RELEASE TABL ETS safely and effectively. See full prescribing information for QUETIAPINE EXTENDED-RELEASE TABLETS. QUETIAPINE extended-relea se tablets for oral use Initial Initial U.S. Approval: 1997
10135-657-602020-02-20C16284748780-19d75b9d0-d537-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use QUETIAPINE EXT ENDED-RELEASE TABL ETS safely and effectively. See full prescribing information for QUETIAPINE EXTENDED-RELEASE TABLETS. QUETIAPINE extended-relea se tablets for oral use Initial Initial U.S. Approval: 1997
10135-657-602020-01-31C16284748780-19d75b9d0-d537-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use QUETIAPINE EXT ENDED-RELEASE TABL ETS safely and effectively. See full prescribing information for QUETIAPINE EXTENDED-RELEASE TABLETS. QUETIAPINE extended-relea se tablets for oral use Initial Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-657-60QuetiapineExtended Release60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-657-60EA - Each10135-6579f09a2c4-62fb-424a-8b83-d3048e40430f12018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-657QUETIAPINE EXTENDED RELEASE (QUETIAPINE) TABLET, FILM COATED, EXTENDED RELEASE [MARLEX PHARMACEUTICALS INC]2Legacy NDC, 1 package rows20200221_a70d857a-50d3-4e69-828c-a72fd6b98c99.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895670QUEtiapine fumarate 150 MG 24HR Extended Release Oral TabletPSNa70d857a-50d3-4e69-828c-a72fd6b98c992
721791QUEtiapine fumarate 200 MG 24HR Extended Release Oral TabletPSNa70d857a-50d3-4e69-828c-a72fd6b98c992
721794QUEtiapine fumarate 300 MG 24HR Extended Release Oral TabletPSNa70d857a-50d3-4e69-828c-a72fd6b98c992
721796QUEtiapine fumarate 400 MG 24HR Extended Release Oral TabletPSNa70d857a-50d3-4e69-828c-a72fd6b98c992
89567024 HR quetiapine 150 MG Extended Release Oral TabletSCDa70d857a-50d3-4e69-828c-a72fd6b98c992
72179124 HR quetiapine 200 MG Extended Release Oral TabletSCDa70d857a-50d3-4e69-828c-a72fd6b98c992
72179424 HR quetiapine 300 MG Extended Release Oral TabletSCDa70d857a-50d3-4e69-828c-a72fd6b98c992
72179624 HR quetiapine 400 MG Extended Release Oral TabletSCDa70d857a-50d3-4e69-828c-a72fd6b98c992
895670quetiapine 150 MG (as quetiapine fumarate 173 MG) 24 HR Extended Release Oral TabletSYa70d857a-50d3-4e69-828c-a72fd6b98c992
895670quetiapine 150 MG 24 HR Extended Release Oral TabletSYa70d857a-50d3-4e69-828c-a72fd6b98c992
721791quetiapine 200 MG (as quetiapine fumarate 230 MG) 24 HR Extended Release Oral TabletSYa70d857a-50d3-4e69-828c-a72fd6b98c992
721791quetiapine 200 MG 24 HR Extended Release Oral TabletSYa70d857a-50d3-4e69-828c-a72fd6b98c992
721794quetiapine 300 MG (as quetiapine fumarate 345 MG) 24 HR Extended Release Oral TabletSYa70d857a-50d3-4e69-828c-a72fd6b98c992
721794quetiapine 300 MG 24 HR Extended Release Oral TabletSYa70d857a-50d3-4e69-828c-a72fd6b98c992
721796quetiapine 400 MG (as quetiapine fumarate 461 MG) 24 HR Extended Release Oral TabletSYa70d857a-50d3-4e69-828c-a72fd6b98c992

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10135-657-601013506576060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10135-657-60) 2018-05-010000-00-00NoNoCurrent