QUETIAPINE FUMARATE

Product NDC
71399-3000
11-digit product format
713993000
Labeler code
71399
Product ID
71399-3000_160c21c2-63f7-49a9-aa10-9767a153cf18
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
QUETIAPINE FUMARATE
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Akron Pharma Inc
Application
ANDA209635
Marketing category
ANDA
Marketing start
2018-05-10
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-3000-6EA - Each71399-3000f1b26574-f438-4233-8ca4-356f445d4ba912018-08-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71399-3000-67139930000660 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71399-3000-6) 2018-05-100000-00-00NoNoCurrent