FDA.reportPublic FDA data

QUETIAPINE FUMARATE

Product NDC
16729-097
11-digit product format
167290097
Labeler code
16729
Product ID
16729-097_4390e24f-daa6-84a2-e063-6294a90a48ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
QUETIAPINE FUMARATE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA090681
Marketing category
ANDA
Marketing start
2016-11-01
Substance
QUETIAPINE FUMARATE
Active strength
400 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 FUMARATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUETIAPINE FUMARATE400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S3PL1B6UJ
Rxcui721791, 721794, 721796, 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
16729-097-12QUETIAPINE FUMARATE60 in 1 BOTTLETABLET, EXTENDED RELEASE6013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-097-12EA - Each16729-0974ef312c3-a7a2-4077-af02-3695e7b54cca12016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-097QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE [ACCORD HEALTHCARE INC.]12Current NDC, Legacy NDC, 1 package rows20240118_3ffe0294-3959-2755-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895670QUEtiapine fumarate 150 MG 24HR Extended Release Oral TabletPSN3ffe0294-3959-2755-e054-00144ff8d46c13
721791QUEtiapine fumarate 200 MG 24HR Extended Release Oral TabletPSN3ffe0294-3959-2755-e054-00144ff8d46c13
721794QUEtiapine fumarate 300 MG 24HR Extended Release Oral TabletPSN3ffe0294-3959-2755-e054-00144ff8d46c13
721796QUEtiapine fumarate 400 MG 24HR Extended Release Oral TabletPSN3ffe0294-3959-2755-e054-00144ff8d46c13
89567024 HR quetiapine 150 MG Extended Release Oral TabletSCD3ffe0294-3959-2755-e054-00144ff8d46c13
72179124 HR quetiapine 200 MG Extended Release Oral TabletSCD3ffe0294-3959-2755-e054-00144ff8d46c13
72179424 HR quetiapine 300 MG Extended Release Oral TabletSCD3ffe0294-3959-2755-e054-00144ff8d46c13
72179624 HR quetiapine 400 MG Extended Release Oral TabletSCD3ffe0294-3959-2755-e054-00144ff8d46c13
895670quetiapine 150 MG (as quetiapine fumarate 173 MG) 24 HR Extended Release Oral TabletSY3ffe0294-3959-2755-e054-00144ff8d46c13
895670quetiapine 150 MG 24 HR Extended Release Oral TabletSY3ffe0294-3959-2755-e054-00144ff8d46c13
721791quetiapine 200 MG (as quetiapine fumarate 230 MG) 24 HR Extended Release Oral TabletSY3ffe0294-3959-2755-e054-00144ff8d46c13
721791quetiapine 200 MG 24 HR Extended Release Oral TabletSY3ffe0294-3959-2755-e054-00144ff8d46c13
721794quetiapine 300 MG (as quetiapine fumarate 345 MG) 24 HR Extended Release Oral TabletSY3ffe0294-3959-2755-e054-00144ff8d46c13
721794quetiapine 300 MG 24 HR Extended Release Oral TabletSY3ffe0294-3959-2755-e054-00144ff8d46c13
721796quetiapine 400 MG (as quetiapine fumarate 461 MG) 24 HR Extended Release Oral TabletSY3ffe0294-3959-2755-e054-00144ff8d46c13
721796QUEtiapine fumarate 400 MG 24HR Extended Release Oral TabletPSNfd17163f-a308-5c9a-e053-6294a90a2ae62
72179624 HR quetiapine 400 MG Extended Release Oral TabletSCDfd17163f-a308-5c9a-e053-6294a90a2ae62
721796quetiapine 400 MG (as quetiapine fumarate 461 MG) 24 HR Extended Release Oral TabletSYfd17163f-a308-5c9a-e053-6294a90a2ae62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-097-121672900971260 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-097-12) 2016-11-010000-00-00NoNoCurrent