Levocetirizine Dihydrochloride

Product NDC
50090-2591
11-digit product format
500902591
Labeler code
50090
Product ID
50090-2591_11033f94-47b1-46b0-9bef-52855f90ad5d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levocetirizine Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
36cf9111-9cc4-8f59-a74c-0c1cfbd4a760Product name720190702

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2591-0Levocetirizine Dihydrochloride30 in 1 BOTTLETABLET308
50090-2591-1Levocetirizine Dihydrochloride90 in 1 BOTTLETABLET908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2591-0EA - Each50090-2591213e5cf0-4e7c-454d-bb75-589ba7e1354812019-04-11
50090-2591-1EA - Each50090-2591cb58568f-532f-4ba8-8cf8-ba731b08a16a12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2591LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]8Legacy NDC, 2 package rows20200121_2042b8be-c8c1-418e-ad48-851ea61b2726.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSN2042b8be-c8c1-418e-ad48-851ea61b27268
855172levocetirizine dihydrochloride 5 MG Oral TabletSCD2042b8be-c8c1-418e-ad48-851ea61b27268
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSY2042b8be-c8c1-418e-ad48-851ea61b27268

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2591-05009025910030 TABLET in 1 BOTTLE (50090-2591-0) 30 tablet2016-11-080000-00-00NoNoCurrent
50090-2591-15009025910190 in 1 BOTTLEHistorical