SEROQUEL

Product NDC
55289-187
11-digit product format
552890187
Labeler code
55289
Product ID
55289-187_e2332c11-4193-e083-e053-2995a90a215d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
quetiapine fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
NDA020639
Marketing category
NDA
Marketing start
1997-10-01
Marketing end
0000-00-00
Substance
QUETIAPINE FUMARATE
Active strength
100 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
55289-187-30EA - Each55289-18723fed15e-f395-4b0d-9928-27224180362012012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55289-187-305528901873030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-187-30) 2011-11-090000-00-00NoNoCurrent