FDA.reportPublic FDA data

Quetiapine

Product NDC
50228-384
11-digit product format
502280384
Labeler code
50228
Product ID
50228-384_47ce17ad-f0c0-8ce7-e063-6294a90a7520
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
ScieGen Pharmaceuticals, Inc
Application
ANDA209635
Marketing category
ANDA
Marketing start
2017-11-29
Substance
QUETIAPINE FUMARATE
Active strength
400 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Quetiapine
Brand name suffix
Extended Release
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUETIAPINE FUMARATE400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S3PL1B6UJ
Rxcui721791, 721794, 721796, 853201, 895670

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ef42f82-f087-0d2c-105f-f791ca69210eProduct name820250729
21205abd-8c89-4943-9f85-908f3d4fc3bbProduct name520230501

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50228-384-05QuetiapineExtended Release500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE50011
50228-384-30QuetiapineExtended Release30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3011
50228-384-60QuetiapineExtended Release60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE6011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-384-60EA - Each50228-3849167d4f8-ca21-4a48-91cc-3abef0c4930b12019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-384QUETIAPINE EXTENDED RELEASE (QUETIAPINE) TABLET, FILM COATED, EXTENDED RELEASE [SCIEGEN PHARMACEUTICALS, INC]8Current NDC, Legacy NDC, 3 package rows20240731_5e4a84b1-fb8c-44d0-8213-51e43d71db69.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895670QUEtiapine fumarate 150 MG 24HR Extended Release Oral TabletPSN5e4a84b1-fb8c-44d0-8213-51e43d71db6911
721791QUEtiapine fumarate 200 MG 24HR Extended Release Oral TabletPSN5e4a84b1-fb8c-44d0-8213-51e43d71db6911
721794QUEtiapine fumarate 300 MG 24HR Extended Release Oral TabletPSN5e4a84b1-fb8c-44d0-8213-51e43d71db6911
721796QUEtiapine fumarate 400 MG 24HR Extended Release Oral TabletPSN5e4a84b1-fb8c-44d0-8213-51e43d71db6911
853201QUEtiapine fumarate 50 MG 24HR Extended Release Oral TabletPSN5e4a84b1-fb8c-44d0-8213-51e43d71db6911
89567024 HR quetiapine 150 MG Extended Release Oral TabletSCD5e4a84b1-fb8c-44d0-8213-51e43d71db6911
72179124 HR quetiapine 200 MG Extended Release Oral TabletSCD5e4a84b1-fb8c-44d0-8213-51e43d71db6911
72179424 HR quetiapine 300 MG Extended Release Oral TabletSCD5e4a84b1-fb8c-44d0-8213-51e43d71db6911
72179624 HR quetiapine 400 MG Extended Release Oral TabletSCD5e4a84b1-fb8c-44d0-8213-51e43d71db6911
85320124 HR quetiapine 50 MG Extended Release Oral TabletSCD5e4a84b1-fb8c-44d0-8213-51e43d71db6911
895670quetiapine 150 MG (as quetiapine fumarate 173 MG) 24 HR Extended Release Oral TabletSY5e4a84b1-fb8c-44d0-8213-51e43d71db6911
895670quetiapine 150 MG 24 HR Extended Release Oral TabletSY5e4a84b1-fb8c-44d0-8213-51e43d71db6911
721791quetiapine 200 MG (as quetiapine fumarate 230 MG) 24 HR Extended Release Oral TabletSY5e4a84b1-fb8c-44d0-8213-51e43d71db6911
721791quetiapine 200 MG 24 HR Extended Release Oral TabletSY5e4a84b1-fb8c-44d0-8213-51e43d71db6911
721794quetiapine 300 MG (as quetiapine fumarate 345 MG) 24 HR Extended Release Oral TabletSY5e4a84b1-fb8c-44d0-8213-51e43d71db6911
721794quetiapine 300 MG 24 HR Extended Release Oral TabletSY5e4a84b1-fb8c-44d0-8213-51e43d71db6911
721796quetiapine 400 MG (as quetiapine fumarate 461 MG) 24 HR Extended Release Oral TabletSY5e4a84b1-fb8c-44d0-8213-51e43d71db6911
853201quetiapine 50 MG (as quetiapine fumarate 58 MG) 24 HR Extended Release Oral TabletSY5e4a84b1-fb8c-44d0-8213-51e43d71db6911
853201quetiapine 50 MG 24 HR Extended Release Oral TabletSY5e4a84b1-fb8c-44d0-8213-51e43d71db6911
895670QUEtiapine fumarate 150 MG 24HR Extended Release Oral TabletPSN04cd529c-198b-5b85-e063-6294a90a46843
721791QUEtiapine fumarate 200 MG 24HR Extended Release Oral TabletPSN04cd529c-198b-5b85-e063-6294a90a46843
721794QUEtiapine fumarate 300 MG 24HR Extended Release Oral TabletPSN04cd529c-198b-5b85-e063-6294a90a46843
721796QUEtiapine fumarate 400 MG 24HR Extended Release Oral TabletPSN04cd529c-198b-5b85-e063-6294a90a46843
853201QUEtiapine fumarate 50 MG 24HR Extended Release Oral TabletPSN04cd529c-198b-5b85-e063-6294a90a46843
89567024 HR quetiapine 150 MG Extended Release Oral TabletSCD04cd529c-198b-5b85-e063-6294a90a46843
72179124 HR quetiapine 200 MG Extended Release Oral TabletSCD04cd529c-198b-5b85-e063-6294a90a46843
72179424 HR quetiapine 300 MG Extended Release Oral TabletSCD04cd529c-198b-5b85-e063-6294a90a46843
72179624 HR quetiapine 400 MG Extended Release Oral TabletSCD04cd529c-198b-5b85-e063-6294a90a46843
85320124 HR quetiapine 50 MG Extended Release Oral TabletSCD04cd529c-198b-5b85-e063-6294a90a46843
895670quetiapine 150 MG (as quetiapine fumarate 173 MG) 24 HR Extended Release Oral TabletSY04cd529c-198b-5b85-e063-6294a90a46843
895670quetiapine 150 MG 24 HR Extended Release Oral TabletSY04cd529c-198b-5b85-e063-6294a90a46843
721791quetiapine 200 MG (as quetiapine fumarate 230 MG) 24 HR Extended Release Oral TabletSY04cd529c-198b-5b85-e063-6294a90a46843
721791quetiapine 200 MG 24 HR Extended Release Oral TabletSY04cd529c-198b-5b85-e063-6294a90a46843
721794quetiapine 300 MG (as quetiapine fumarate 345 MG) 24 HR Extended Release Oral TabletSY04cd529c-198b-5b85-e063-6294a90a46843
721794quetiapine 300 MG 24 HR Extended Release Oral TabletSY04cd529c-198b-5b85-e063-6294a90a46843
721796quetiapine 400 MG (as quetiapine fumarate 461 MG) 24 HR Extended Release Oral TabletSY04cd529c-198b-5b85-e063-6294a90a46843
853201quetiapine 50 MG (as quetiapine fumarate 58 MG) 24 HR Extended Release Oral TabletSY04cd529c-198b-5b85-e063-6294a90a46843
853201quetiapine 50 MG 24 HR Extended Release Oral TabletSY04cd529c-198b-5b85-e063-6294a90a46843
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
50228-384-0550228038405500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-384-05) 2017-11-290000-00-00NoNoCurrent
50228-384-305022803843030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-384-30) 2017-11-290000-00-00NoNoCurrent
50228-384-605022803846060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-384-60) 2017-11-290000-00-00NoNoCurrent