FDA.reportPublic FDA data

Quetiapine fumarate

Product NDC
70518-1919
11-digit product format
705181919
Labeler code
70518
Product ID
70518-1919_500d557f-40d9-527f-e063-6294a90aae86
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
quetiapine fumarate
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA201109
Marketing category
ANDA
Marketing start
2019-02-27
Substance
QUETIAPINE FUMARATE
Active strength
300 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 FUMARATE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S3PL1B6UJ
Rxcui312745

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
70518-1919-0Quetiapine fumarate30 in 1 BLISTER PACKTABLET305
70518-1919-1Quetiapine fumarate30 in 1 BLISTER PACKTABLET305

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312745QUEtiapine fumarate 300 MG Oral TabletPSN695415b1-083d-4540-9f41-bde4b201f8345
312745quetiapine 300 MG Oral TabletSCD695415b1-083d-4540-9f41-bde4b201f8345
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSY695415b1-083d-4540-9f41-bde4b201f8345

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-1919-07051819190030 in 1 BLISTER PACKHistorical
70518-1919-17051819190130 TABLET in 1 BLISTER PACK (70518-1919-1) 30 tablet2026-04-22NoNoHistorical