FDA.reportPublic FDA data

Quetiapine

Product NDC
68001-600
11-digit product format
680010600
Labeler code
68001
Product ID
68001-600_487e93eb-c251-17da-e063-6294a90a6517
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA215478
Marketing category
ANDA
Marketing start
2023-11-01
Substance
QUETIAPINE FUMARATE
Active strength
200 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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUETIAPINE FUMARATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S3PL1B6UJ
Rxcui721791, 721794, 721796, 853201, 895670

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ef42f82-f087-0d2c-105f-f791ca69210eProduct name820250729
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
21205abd-8c89-4943-9f85-908f3d4fc3bbProduct name520230501
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-600-06Quetiapine60 in 1 BOTTLETABLET, EXTENDED RELEASE604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-600QUETIAPINE TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]3Current NDC, 1 package rows20250410_186c5cde-5066-4436-99ef-28049c12826b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895670QUEtiapine fumarate 150 MG 24HR Extended Release Oral TabletPSN186c5cde-5066-4436-99ef-28049c12826b4
721791QUEtiapine fumarate 200 MG 24HR Extended Release Oral TabletPSN186c5cde-5066-4436-99ef-28049c12826b4
721794QUEtiapine fumarate 300 MG 24HR Extended Release Oral TabletPSN186c5cde-5066-4436-99ef-28049c12826b4
721796QUEtiapine fumarate 400 MG 24HR Extended Release Oral TabletPSN186c5cde-5066-4436-99ef-28049c12826b4
853201QUEtiapine fumarate 50 MG 24HR Extended Release Oral TabletPSN186c5cde-5066-4436-99ef-28049c12826b4
89567024 HR quetiapine 150 MG Extended Release Oral TabletSCD186c5cde-5066-4436-99ef-28049c12826b4
72179124 HR quetiapine 200 MG Extended Release Oral TabletSCD186c5cde-5066-4436-99ef-28049c12826b4
72179424 HR quetiapine 300 MG Extended Release Oral TabletSCD186c5cde-5066-4436-99ef-28049c12826b4
72179624 HR quetiapine 400 MG Extended Release Oral TabletSCD186c5cde-5066-4436-99ef-28049c12826b4
85320124 HR quetiapine 50 MG Extended Release Oral TabletSCD186c5cde-5066-4436-99ef-28049c12826b4
895670quetiapine 150 MG (as quetiapine fumarate 173 MG) 24 HR Extended Release Oral TabletSY186c5cde-5066-4436-99ef-28049c12826b4
895670quetiapine 150 MG 24 HR Extended Release Oral TabletSY186c5cde-5066-4436-99ef-28049c12826b4
721791quetiapine 200 MG (as quetiapine fumarate 230 MG) 24 HR Extended Release Oral TabletSY186c5cde-5066-4436-99ef-28049c12826b4
721791quetiapine 200 MG 24 HR Extended Release Oral TabletSY186c5cde-5066-4436-99ef-28049c12826b4
721794quetiapine 300 MG (as quetiapine fumarate 345 MG) 24 HR Extended Release Oral TabletSY186c5cde-5066-4436-99ef-28049c12826b4
721794quetiapine 300 MG 24 HR Extended Release Oral TabletSY186c5cde-5066-4436-99ef-28049c12826b4
721796quetiapine 400 MG (as quetiapine fumarate 461 MG) 24 HR Extended Release Oral TabletSY186c5cde-5066-4436-99ef-28049c12826b4
853201quetiapine 50 MG (as quetiapine fumarate 58 MG) 24 HR Extended Release Oral TabletSY186c5cde-5066-4436-99ef-28049c12826b4
853201quetiapine 50 MG 24 HR Extended Release Oral TabletSY186c5cde-5066-4436-99ef-28049c12826b4
721791QUEtiapine fumarate 200 MG 24HR Extended Release Oral TabletPSN461523b5-8d12-9d96-e063-6394a90ad4c21
72179124 HR quetiapine 200 MG Extended Release Oral TabletSCD461523b5-8d12-9d96-e063-6394a90ad4c21
721791quetiapine 200 MG (as quetiapine fumarate 230 MG) 24 HR Extended Release Oral TabletSY461523b5-8d12-9d96-e063-6394a90ad4c21
721791quetiapine 200 MG 24 HR Extended Release Oral TabletSY461523b5-8d12-9d96-e063-6394a90ad4c21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68001-600-066800106000660 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-600-06) 2023-11-28NoNoHistorical