FDA.reportPublic FDA data

Quetiapine Fumarate

Product NDC
70518-3429
11-digit product format
705183429
Labeler code
70518
Product ID
70518-3429_4f08260b-c543-87ed-e063-6394a90a3639
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine Fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA091388
Marketing category
ANDA
Marketing start
2022-05-26
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
70518-3429-0Quetiapine Fumarate30 in 1 BLISTER PACKTABLET, FILM COATED306

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312743QUEtiapine fumarate 100 MG Oral TabletPSN41dbd5a5-4ae2-4ac1-8135-0fdac5c170b56
312743quetiapine 100 MG Oral TabletSCD41dbd5a5-4ae2-4ac1-8135-0fdac5c170b56
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY41dbd5a5-4ae2-4ac1-8135-0fdac5c170b56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3429-07051834290030 TABLET, FILM COATED in 1 BLISTER PACK (70518-3429-0) 2022-05-260000-00-00NoNoCurrent