Quetiapine Fumarate

Product NDC
50090-7471
11-digit product format
500907471
Labeler code
50090
Product ID
50090-7471_d582eedc-0976-449b-ae78-7c0f62c0016c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA201504
Marketing category
ANDA
Marketing start
2013-03-01
Substance
QUETIAPINE FUMARATE
Active strength
200 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 FUMARATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S3PL1B6UJ
Rxcui317174

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
50090-7471-0Quetiapine Fumarate30 in 1 BOTTLETABLET, FILM COATED3019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7471-0EA - Each50090-74718da02e0c-bc3b-4e67-bd9b-2720c98e952c12025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7471QUETIAPINE FUMARATE TABLET [A-S MEDICATION SOLUTIONS]17Current NDC, 1 package rows20241218_10288afa-c4dc-4897-9ec8-f4573d850779.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317174QUEtiapine fumarate 200 MG Oral TabletPSN10288afa-c4dc-4897-9ec8-f4573d85077919
317174quetiapine 200 MG Oral TabletSCD10288afa-c4dc-4897-9ec8-f4573d85077919
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY10288afa-c4dc-4897-9ec8-f4573d85077919

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7471-05009074710030 TABLET, FILM COATED in 1 BOTTLE (50090-7471-0) 2024-12-12NoNoCurrent