FDA.reportPublic FDA data

Quetiapine Fumarate

Product NDC
50090-5473
11-digit product format
500905473
Labeler code
50090
Product ID
50090-5473_c0926bd7-00ab-4b1f-a043-36091e98dfb8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine Fumarate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA201504
Marketing category
ANDA
Marketing start
2013-03-01
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
Rxcui616483

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
50090-5473-02023-02-07C16284748780-1f386c649-d519-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997
50090-5473-02023-01-30C16284748780-1f386c649-d519-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5473-0Quetiapine Fumarate30 in 1 BOTTLETABLET305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5473-0EA - Each50090-5473d0696646-707c-4ddc-84d4-8bd5fd32963412023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5473QUETIAPINE FUMARATE TABLET [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 1 package rows20230616_95156201-ed16-4806-98a7-d42acc902126.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616483QUEtiapine fumarate 400 MG Oral TabletPSN95156201-ed16-4806-98a7-d42acc9021265
616483quetiapine 400 MG Oral TabletSCD95156201-ed16-4806-98a7-d42acc9021265
616483quetiapine (as quetiapine fumarate) 400 MG Oral TabletSY95156201-ed16-4806-98a7-d42acc9021265

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5473-05009054730030 TABLET in 1 BOTTLE (50090-5473-0) 30 tablet2021-03-020000-00-00NoNoCurrent