FDA.reportPublic FDA data

Quetiapine Fumarate ER

Product NDC
72189-481
11-digit product format
721890481
Labeler code
72189
Product ID
72189-481_2c4e167d-290b-0703-e063-6394a90a9132
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine Fumarate ER
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA090681
Marketing category
ANDA
Marketing start
2023-06-01
Substance
QUETIAPINE FUMARATE
Active strength
150 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 ER
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUETIAPINE FUMARATE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S3PL1B6UJ
Rxcui895670

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
72189-481-30Quetiapine Fumarate ER30 in 1 BOTTLETABLET, EXTENDED RELEASE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-481-30EA - Each72189-481b6b74488-8933-4e36-acd7-022b57e8f0a912023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-481QUETIAPINE FUMARATE ER TABLET, EXTENDED RELEASE [DIRECT_RX]2Current NDC, 1 package rows20250123_fd11db2d-364d-9bd6-e053-6394a90ade0b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895670QUEtiapine fumarate 150 MG 24HR Extended Release Oral TabletPSNfd11db2d-364d-9bd6-e053-6394a90ade0b2
89567024 HR quetiapine 150 MG Extended Release Oral TabletSCDfd11db2d-364d-9bd6-e053-6394a90ade0b2
895670quetiapine 150 MG (as quetiapine fumarate 173 MG) 24 HR Extended Release Oral TabletSYfd11db2d-364d-9bd6-e053-6394a90ade0b2
895670quetiapine 150 MG 24 HR Extended Release Oral TabletSYfd11db2d-364d-9bd6-e053-6394a90ade0b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72189-481-307218904813030 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-481-30) 2023-06-01NoNoHistorical