QUETIAPINE FUMARATE

Product NDC
68001-511
11-digit product format
680010511
Labeler code
68001
Product ID
68001-511_e27efdd5-c194-4d18-e053-2995a90a00ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
QUETIAPINE FUMARATE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bluepoint Laboratories
Application
ANDA206252
Marketing category
ANDA
Marketing start
2021-08-31
Marketing end
0000-00-00
Substance
QUETIAPINE FUMARATE
Active strength
50 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-511-06EA - Each68001-511a9d808bd-e979-4c87-8e28-2b4e34511b3b12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-511QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]4Legacy NDC20250322_529c41df-70e1-4f18-ad36-05e169fa0a07.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68001-511-066800105110660 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-511-06) 2021-08-310000-00-00NoNoCurrent