LEVOCETIRIZINE DIHYDROCHLORIDE

Product NDC
68788-7189
11-digit product format
687887189
Labeler code
68788
Product ID
68788-7189_a0d62278-6f51-4ebe-ad6c-2dd9e5bc7d90
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVOCETIRIZINE DIHYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA205564
Marketing category
ANDA
Marketing start
2018-07-17
Marketing end
0000-00-00
Substance
LEVOCETIRIZINE DIHYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [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
68788-7189-1EA - Each68788-71896345d747-0e75-4680-a699-92dd69d911bc12018-09-05
68788-7189-3EA - Each68788-7189694044a4-4c55-4dda-b899-cae7dafc65f612018-09-05
68788-7189-6EA - Each68788-71896120915f-88ed-487c-b654-d9c90786dc9312018-09-05
68788-7189-9EA - Each68788-7189913e61c1-cbdb-40c2-81ea-e0a65fbfb9dd12018-09-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7189-168788718901100 TABLET, FILM COATED in 1 BOTTLE (68788-7189-1) 2018-07-170000-00-00NoNoCurrent
68788-7189-36878871890330 TABLET, FILM COATED in 1 BOTTLE (68788-7189-3) 2018-07-170000-00-00NoNoCurrent
68788-7189-66878871890660 TABLET, FILM COATED in 1 BOTTLE (68788-7189-6) 2018-07-170000-00-00NoNoCurrent
68788-7189-96878871890990 TABLET, FILM COATED in 1 BOTTLE (68788-7189-9) 2018-07-170000-00-00NoNoCurrent