FDA.reportPublic FDA data

Quetiapine fumarate

Product NDC
67046-0632
11-digit product format
670460632
Labeler code
67046
Product ID
67046-0632_5074b172-311e-43e2-e063-6394a90aa70f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
quetiapine fumarate
Dosage form
TABLET
Route
ORAL
Labeler
Coupler LLC
Application
ANDA201109
Marketing category
ANDA
Marketing start
2026-04-27
Substance
QUETIAPINE FUMARATE
Active strength
100 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Quetiapine fumarate
Listing expiration
2027-12-31

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
67046-0632-3Quetiapine fumarate30 in 1 BLISTER PACKTABLET301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312743QUEtiapine fumarate 100 MG Oral TabletPSN5074c897-bcf9-7497-e063-6394a90aa7331
312743quetiapine 100 MG Oral TabletSCD5074c897-bcf9-7497-e063-6394a90aa7331
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY5074c897-bcf9-7497-e063-6394a90aa7331

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67046-0632-36704606320330 TABLET in 1 BLISTER PACK (67046-0632-3) 30 tablet2026-04-27NoNoHistorical