Quetiapine fumarate

Product NDC
68788-7195
11-digit product format
687887195
Labeler code
68788
Product ID
68788-7195_256c58be-db83-4482-b26f-680a16c293f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA203359
Marketing category
ANDA
Marketing start
2018-07-19
Marketing end
0000-00-00
Substance
QUETIAPINE FUMARATE
Active strength
400 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7195-1EA - Each68788-719525159a46-7583-43ce-a015-3c6e1db3ee7b12018-09-05
68788-7195-3EA - Each68788-7195b42d06eb-c572-4c37-9f83-e7897a59afaa12018-09-05
68788-7195-6EA - Each68788-71955db4d6b9-64ef-4a2e-83a5-8b1989a0391a12018-09-05
68788-7195-8EA - Each68788-7195b2052329-b1c7-494d-b14f-9c38472a570212018-09-05
68788-7195-9EA - Each68788-7195bfdf5384-eb39-4eb3-b684-d23e2cf7316412018-09-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7195-168788719501100 TABLET, FILM COATED in 1 BOTTLE (68788-7195-1) 2018-07-190000-00-00NoNoCurrent
68788-7195-36878871950330 TABLET, FILM COATED in 1 BOTTLE (68788-7195-3) 2018-07-190000-00-00NoNoCurrent
68788-7195-66878871950660 TABLET, FILM COATED in 1 BOTTLE (68788-7195-6) 2018-07-190000-00-00NoNoCurrent
68788-7195-868788719508120 TABLET, FILM COATED in 1 BOTTLE (68788-7195-8) 2018-07-190000-00-00NoNoCurrent
68788-7195-96878871950990 TABLET, FILM COATED in 1 BOTTLE (68788-7195-9) 2018-07-190000-00-00NoNoCurrent