Levocetirizine Dihydrochloride

Product NDC
50090-5341
11-digit product format
500905341
Labeler code
50090
Product ID
50090-5341_ec104719-030c-4cd3-bdf8-09e2ce339eb8
Type
HUMAN OTC DRUG
Nonproprietary name
Levocetirizine Dihydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA213513
Marketing category
ANDA
Marketing start
2020-10-28
Marketing end
0000-00-00
Substance
LEVOCETIRIZINE DIHYDROCHLORIDE
Active strength
5 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
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
50090-5341-0Levocetirizine Dihydrochloride30 in 1 BOTTLETABLET, FILM COATED303
50090-5341-1Levocetirizine Dihydrochloride90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5341LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20210417_3fad12b0-1bff-4899-99bb-0608b42d3be3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSN3fad12b0-1bff-4899-99bb-0608b42d3be33
855172levocetirizine dihydrochloride 5 MG Oral TabletSCD3fad12b0-1bff-4899-99bb-0608b42d3be33
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSY3fad12b0-1bff-4899-99bb-0608b42d3be33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5341-05009053410030 TABLET, FILM COATED in 1 BOTTLE (50090-5341-0) 2020-11-040000-00-00NoNoCurrent
50090-5341-15009053410190 TABLET, FILM COATED in 1 BOTTLE (50090-5341-1) 2020-11-040000-00-00NoNoCurrent