Quetiapine fumarate

Product NDC
68071-2728
11-digit product format
680712728
Labeler code
68071
Product ID
68071-2728_dfb482e6-a407-c450-e053-2995a90a20b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA201190
Marketing category
ANDA
Marketing start
2012-03-28
Marketing end
0000-00-00
Substance
QUETIAPINE FUMARATE
Active strength
300 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ef42f82-f087-0d2c-105f-f791ca69210eProduct name820250729
21205abd-8c89-4943-9f85-908f3d4fc3bbProduct name520230501

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2728-6Quetiapine fumarate60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2728QUETIAPINE FUMARATE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20220524_dfb4820d-d34f-2ddf-e053-2a95a90a9c21.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312745QUEtiapine fumarate 300 MG Oral TabletPSNdfb4820d-d34f-2ddf-e053-2a95a90a9c211
312745quetiapine 300 MG Oral TabletSCDdfb4820d-d34f-2ddf-e053-2a95a90a9c211
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSYdfb4820d-d34f-2ddf-e053-2a95a90a9c211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2728-66807127280660 TABLET, FILM COATED in 1 BOTTLE (68071-2728-6) 2022-05-230000-00-00NoNoCurrent