Levocetirizine Dihydrochloride

Product NDC
63187-922
11-digit product format
631870922
Labeler code
63187
Product ID
63187-922_93640180-fa14-4cca-b133-ca82177287c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levocetirizine Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA203027
Marketing category
ANDA
Marketing start
2015-02-13
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-922-30EA - Each63187-922a198c2e9-8bc3-4497-8fad-ba4b4f1fbf1e12018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-922LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [PROFICIENT RX LP]3Legacy NDC20191108_a06f67f6-141e-4879-8f87-c0422f4bfa81.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-922-306318709223030 TABLET in 1 BOTTLE (63187-922-30) 30 tablet2017-10-020000-00-00NoNoCurrent
63187-922-606318709226090 TABLET in 1 BOTTLE (63187-922-60) 90 tablet2017-10-020000-00-00NoNoCurrent
63187-922-906318709229060 TABLET in 1 BOTTLE (63187-922-90) 60 tablet2017-10-020000-00-00NoNoCurrent