Quetiapine

Product NDC
0615-7987
11-digit product format
006157987
Labeler code
0615
Product ID
0615-7987_b3304fb3-74ef-4db3-b4b3-627ab6c5bdef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA202152
Marketing category
ANDA
Marketing start
2012-03-28
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-7987-050061579870515 TABLET, FILM COATED in 1 BLISTER PACK (0615-7987-05) 2016-05-060000-00-00NoNoCurrent
0615-7987-30006157987306 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-7987-30) > 5 TABLET, FILM COATED in 1 BLISTER PACK6 blister pack2016-05-130000-00-00NoNoCurrent
0615-7987-390061579873930 TABLET, FILM COATED in 1 BLISTER PACK (0615-7987-39) 2016-05-060000-00-00NoNoCurrent