FDA.reportPublic FDA data

Quetiapine Fumarate

Product NDC
67046-1649
11-digit product format
670461649
Labeler code
67046
Product ID
67046-1649_48727af1-1bd2-125a-e063-6394a90a7150
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine Fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Coupler LLC
Application
ANDA202674
Marketing category
ANDA
Marketing start
2026-01-15
Substance
QUETIAPINE FUMARATE
Active strength
50 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 FUMARATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S3PL1B6UJ
Rxcui616487

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
67046-1649-3Quetiapine Fumarate30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616487QUEtiapine fumarate 50 MG Oral TabletPSN4872793c-a7be-1b65-e063-6394a90a8b3a1
616487quetiapine 50 MG Oral TabletSCD4872793c-a7be-1b65-e063-6394a90a8b3a1
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSY4872793c-a7be-1b65-e063-6394a90a8b3a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67046-1649-36704616490330 TABLET, FILM COATED in 1 BLISTER PACK (67046-1649-3) 2026-01-15NoNoHistorical