FDA.reportPublic FDA data

Quetiapine fumarate

Product NDC
80425-0413
11-digit product format
804250413
Labeler code
80425
Product ID
80425-0413_1cfc689e-77dd-d388-e063-6394a90a81ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
quetiapine fumarate
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA201109
Marketing category
ANDA
Marketing start
2024-07-11
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
80425-0413-1Quetiapine fumarate30 in 1 BOTTLETABLET301
80425-0413-2Quetiapine fumarate60 in 1 BOTTLETABLET601
80425-0413-3Quetiapine fumarate90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0413-1EA - Each80425-0413b2c253ba-9ec4-455e-bb39-dbb03640fca612024-08-12
80425-0413-2EA - Each80425-04135753aa80-8877-41e2-b605-01f83f3a5d9b12024-08-12
80425-0413-3EA - Each80425-04136a9dd31f-d9cf-4b21-9113-c392ebd264dd12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0413QUETIAPINE FUMARATE TABLET [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 3 package rows20240712_1cfc847b-0d8d-fc94-e063-6394a90a311f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312743QUEtiapine fumarate 100 MG Oral TabletPSN1cfc847b-0d8d-fc94-e063-6394a90a311f1
312743quetiapine 100 MG Oral TabletSCD1cfc847b-0d8d-fc94-e063-6394a90a311f1
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY1cfc847b-0d8d-fc94-e063-6394a90a311f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0413-18042504130130 TABLET in 1 BOTTLE (80425-0413-1) 30 tablet2024-07-11NoNoHistorical
80425-0413-28042504130260 TABLET in 1 BOTTLE (80425-0413-2) 60 tablet2024-07-11NoNoHistorical
80425-0413-38042504130390 TABLET in 1 BOTTLE (80425-0413-3) 90 tablet2024-07-11NoNoHistorical