Quetiapine fumarate

Product NDC
68788-7950
11-digit product format
687887950
Labeler code
68788
Product ID
68788-7950_7517a684-bf30-47aa-8218-87406892cb4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA201190
Marketing category
ANDA
Marketing start
2021-07-08
Marketing end
0000-00-00
Substance
QUETIAPINE FUMARATE
Active strength
200 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
68788-7950-1EA - Each68788-795036666766-2f78-4df2-80ff-158e1eb492b612021-08-05
68788-7950-3EA - Each68788-7950e4981d3e-158c-4fe4-b8d9-a8380d4579eb12021-08-05
68788-7950-6EA - Each68788-795069028112-1da5-4b52-8835-e8f6f7f4337e12021-08-05
68788-7950-8EA - Each68788-79502845bf52-2000-4b28-95d5-11a99e768a6f12021-08-05
68788-7950-9EA - Each68788-7950afd5205b-b560-46a9-bc92-4469f3bfe6ac12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7950QUETIAPINE FUMARATE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]4Legacy NDC20240806_534732b5-925d-4476-b6d8-12ca403e6d00.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7950-168788795001100 TABLET, FILM COATED in 1 BOTTLE (68788-7950-1) 2021-07-080000-00-00NoNoCurrent
68788-7950-36878879500330 TABLET, FILM COATED in 1 BOTTLE (68788-7950-3) 2021-07-080000-00-00NoNoCurrent
68788-7950-66878879500660 TABLET, FILM COATED in 1 BOTTLE (68788-7950-6) 2021-07-080000-00-00NoNoCurrent
68788-7950-868788795008120 TABLET, FILM COATED in 1 BOTTLE (68788-7950-8) 2021-07-080000-00-00NoNoCurrent
68788-7950-96878879500990 TABLET, FILM COATED in 1 BOTTLE (68788-7950-9) 2021-07-080000-00-00NoNoCurrent