FDA.reportPublic FDA data

Quetiapine

Product NDC
69948-003
11-digit product format
699480003
Labeler code
69948
Product ID
69948-003_47232802-9e04-c181-e063-6394a90a9d90
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
AlignScience Pharma Inc.
Application
ANDA209497
Marketing category
ANDA
Marketing start
2020-12-31
Substance
QUETIAPINE FUMARATE
Active strength
200 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Quetiapine
Brand name suffix
Extended-Release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUETIAPINE FUMARATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S3PL1B6UJ
Rxcui721791, 895670

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
69948-003-032025-12-28C16284748780-1ba0f9c33-13b0-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use QUETIAPINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for QUETIAPINE EXTENDED-RELEASE TABLETS. QUETIAPINE extended-release tablets, for oral use Initial U.S. Approval: 1997
69948-003-112025-12-28C16284748780-1ba0f9c33-13b0-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use QUETIAPINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for QUETIAPINE EXTENDED-RELEASE TABLETS. QUETIAPINE extended-release tablets, for oral use Initial U.S. Approval: 1997
69948-003-032021-01-29C16284748780-1ba0f9c33-13b0-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use QUETIAPINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for QUETIAPINE EXTENDED-RELEASE TABLETS. QUETIAPINE extended-release tablets, for oral use Initial U.S. Approval: 1997
69948-003-112021-01-29C16284748780-1ba0f9c33-13b0-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use QUETIAPINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for QUETIAPINE EXTENDED-RELEASE TABLETS. QUETIAPINE extended-release tablets, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69948-003-03QuetiapineExtended-Release60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE609
69948-003-11QuetiapineExtended-Release500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69948-003QUETIAPINE EXTENDED-RELEASE (QUETIAPINE ) TABLET, FILM COATED, EXTENDED RELEASE QUETIAPINE EXTENDED-RELEASE (QUETIAPINE) TABLET, FILM COATED, EXTENDED RELEASE [ALIGNSCIENCE PHARMA INC.]7Current NDC, Legacy NDC, 2 package rows20200331_db3ba268-21a2-4988-b5c1-353741bcaee5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895670QUEtiapine fumarate 150 MG 24HR Extended Release Oral TabletPSNdb3ba268-21a2-4988-b5c1-353741bcaee59
721791QUEtiapine fumarate 200 MG 24HR Extended Release Oral TabletPSNdb3ba268-21a2-4988-b5c1-353741bcaee59
89567024 HR quetiapine 150 MG Extended Release Oral TabletSCDdb3ba268-21a2-4988-b5c1-353741bcaee59
72179124 HR quetiapine 200 MG Extended Release Oral TabletSCDdb3ba268-21a2-4988-b5c1-353741bcaee59
895670quetiapine 150 MG (as quetiapine fumarate 173 MG) 24 HR Extended Release Oral TabletSYdb3ba268-21a2-4988-b5c1-353741bcaee59
895670quetiapine 150 MG 24 HR Extended Release Oral TabletSYdb3ba268-21a2-4988-b5c1-353741bcaee59
721791quetiapine 200 MG (as quetiapine fumarate 230 MG) 24 HR Extended Release Oral TabletSYdb3ba268-21a2-4988-b5c1-353741bcaee59
721791quetiapine 200 MG 24 HR Extended Release Oral TabletSYdb3ba268-21a2-4988-b5c1-353741bcaee59

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69948-003-036994800030360 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69948-003-03) 2020-12-31NoNoCurrent
69948-003-1169948000311500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69948-003-11) 2025-12-29NoNoCurrent