Quetiapine Fumarate

Product NDC
52817-163
11-digit product format
528170163
Labeler code
52817
Product ID
52817-163_b67989d1-c748-3488-e053-2995a90a6a6a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine Fumarate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
TruPharma, LLC
Application
ANDA206260
Marketing category
ANDA
Marketing start
2017-05-10
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52817-163-60EA - Each52817-1632a48d37f-f8cf-4a48-a6c2-1a0686526d2a12017-06-15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52817-163-605281701636060 TABLET, EXTENDED RELEASE in 1 BOTTLE (52817-163-60) 2017-05-100000-00-00NoNoCurrent