Quetiapine Fumarate

Product NDC
0310-8284
11-digit product format
003108284
Labeler code
0310
Product ID
0310-8284_403797ba-33a5-4b31-a1ca-ef756e655625
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine Fumarate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
AstraZeneca Pharmaceuticals LP
Application
NDA022047
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2017-05-01
Marketing end
2021-02-28
Substance
QUETIAPINE FUMARATE
Active strength
400 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0310-8284-60EA - Each0310-8284440f8a40-13c1-4b36-b2c2-31db6d3bbe1312017-06-15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0310-8284-600031082846060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0310-8284-60) 2017-05-012021-02-28NoNoCurrent