Quetiapine fumarate

Product NDC
68788-7960
11-digit product format
687887960
Labeler code
68788
Product ID
68788-7960_06c44828-c4aa-43d8-94e3-49df18e09a55
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
2021-07-19
Marketing end
0000-00-00
Substance
QUETIAPINE FUMARATE
Active strength
100 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
68788-7960-1EA - Each68788-7960adfab97f-3617-43e1-b49c-87659b8a2bb312021-08-05
68788-7960-3EA - Each68788-796018769c2b-fdec-4a63-805a-0a615f43823812021-08-05
68788-7960-6EA - Each68788-7960d7381fbb-5681-4e6f-84b2-d83a9c22ac0812021-08-05
68788-7960-8EA - Each68788-79600f1b98d2-c5f2-4173-ac63-656501513f5b12021-08-05
68788-7960-9EA - Each68788-796007afffe8-1598-4dc8-b14e-43ed04947ffc12021-08-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7960-168788796001100 TABLET, FILM COATED in 1 BOTTLE (68788-7960-1) 2021-07-190000-00-00NoNoCurrent
68788-7960-36878879600330 TABLET, FILM COATED in 1 BOTTLE (68788-7960-3) 2021-07-190000-00-00NoNoCurrent
68788-7960-66878879600660 TABLET, FILM COATED in 1 BOTTLE (68788-7960-6) 2021-07-190000-00-00NoNoCurrent
68788-7960-868788796008120 TABLET, FILM COATED in 1 BOTTLE (68788-7960-8) 2021-07-190000-00-00NoNoCurrent
68788-7960-96878879600990 TABLET, FILM COATED in 1 BOTTLE (68788-7960-9) 2021-07-190000-00-00NoNoCurrent