Levocetirizine Dihydrochloride

Product NDC
43063-831
11-digit product format
430630831
Labeler code
43063
Product ID
43063-831_a44a2a39-22d0-5592-e053-2995a90a5785
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levocetirizine Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA203027
Marketing category
ANDA
Marketing start
2015-02-13
Marketing end
2021-03-01
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
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-831-30EA - Each43063-8313c975380-6750-4547-8d42-aefa049c282612018-03-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-831-304306308313030 TABLET in 1 BOTTLE, PLASTIC (43063-831-30) 30 tablet2018-01-292021-03-01NoNoCurrent