FDA.reportPublic FDA data

Quetiapine Fumarate

Product NDC
50090-5884
11-digit product format
500905884
Labeler code
50090
Product ID
50090-5884_5a3aca3c-b447-40dd-b79e-3b506791860d
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
100 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 FUMARATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S3PL1B6UJ
Rxcui312743

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
50090-5884-0Quetiapine Fumarate30 in 1 BOTTLETABLET3013
50090-5884-1Quetiapine Fumarate90 in 1 BOTTLETABLET9013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5884-0EA - Each50090-588409e2ec2a-5f65-4d01-b6bf-3840221176c312022-06-06
50090-5884-1EA - Each50090-58846e76be3a-c1d8-4cfd-b262-ada4326b851f12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5884QUETIAPINE FUMARATE TABLET [A-S MEDICATION SOLUTIONS]13Current NDC, Legacy NDC, 2 package rows20231125_ccacb909-8ee5-4223-bfee-9cfeae470ecf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312743QUEtiapine fumarate 100 MG Oral TabletPSNccacb909-8ee5-4223-bfee-9cfeae470ecf13
312743quetiapine 100 MG Oral TabletSCDccacb909-8ee5-4223-bfee-9cfeae470ecf13
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSYccacb909-8ee5-4223-bfee-9cfeae470ecf13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5884-05009058840030 TABLET in 1 BOTTLE (50090-5884-0) 30 tablet2021-12-220000-00-00NoNoCurrent
50090-5884-15009058840190 TABLET in 1 BOTTLE (50090-5884-1) 90 tablet2021-12-220000-00-00NoNoCurrent