Quetiapine fumarate

Product NDC
59746-348
11-digit product format
597460348
Labeler code
59746
Product ID
59746-348_d7460263-06fd-437d-a6df-dc0f3a613f67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine fumarate
Dosage form
TABLET
Route
ORAL
Labeler
Jubilant Cadista Pharmaceuticals Inc.
Application
ANDA203150
Marketing category
ANDA
Marketing start
2013-11-27
Marketing end
0000-00-00
Substance
QUETIAPINE FUMARATE
Active strength
25 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59746-348-0159746034801100 TABLET in 1 BOTTLE (59746-348-01) 100 tablet2013-11-270000-00-00NoNoCurrent
59746-348-035974603480310 BLISTER PACK in 1 CARTON (59746-348-03) > 10 TABLET in 1 BLISTER PACK10 blister pack2013-11-270000-00-00NoNoCurrent
59746-348-10597460348101000 TABLET in 1 BOTTLE (59746-348-10) 1000 tablet2013-11-270000-00-00NoNoCurrent
59746-348-605974603486060 TABLET in 1 BOTTLE (59746-348-60) 60 tablet2013-11-270000-00-00NoNoCurrent