quetiapine fumarate

Product NDC
60505-3130
11-digit product format
605053130
Labeler code
60505
Product ID
60505-3130_bdf36658-c472-9290-51e8-289072ae3157
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
quetiapine fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA090960
Marketing category
ANDA
Marketing start
2012-03-27
Marketing end
2021-05-31
Substance
QUETIAPINE FUMARATE
Active strength
25 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
60505-3130-1EA - Each60505-3130fbafad3c-f249-437d-abd0-be4c9c6c79be12012-07-24
60505-3130-8EA - Each60505-3130d4a2bfaf-fc97-46fe-99de-06e9d1e75d5512012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-3130-160505313001100 TABLET, FILM COATED in 1 BOTTLE (60505-3130-1) 2012-03-272021-05-31NoNoCurrent
60505-3130-8605053130081000 TABLET, FILM COATED in 1 BOTTLE (60505-3130-8) 2012-03-272021-05-31NoNoCurrent