levocetirizine dihydrochloride

Product NDC
71335-1952
11-digit product format
713351952
Labeler code
71335
Product ID
71335-1952_373e52bd-0c5b-4b83-9bbf-176df4064b55
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levocetirizine dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203646
Marketing category
ANDA
Marketing start
2014-09-09
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
levocetirizine dihydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOCETIRIZINE DIHYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOD6A38AGA
Rxcui855172

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1952-1levocetirizine dihydrochloride30 in 1 BOTTLETABLET30102
71335-1952-2levocetirizine dihydrochloride90 in 1 BOTTLETABLET90102
71335-1952-3levocetirizine dihydrochloride28 in 1 BOTTLETABLET28102
71335-1952-4levocetirizine dihydrochloride60 in 1 BOTTLETABLET60102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1952LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 4 package rows20231110_8274ca80-e7d3-4f4f-9901-cc5c589b4fef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSN8274ca80-e7d3-4f4f-9901-cc5c589b4fef102
855172levocetirizine dihydrochloride 5 MG Oral TabletSCD8274ca80-e7d3-4f4f-9901-cc5c589b4fef102
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSY8274ca80-e7d3-4f4f-9901-cc5c589b4fef102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1952-17133519520130 TABLET in 1 BOTTLE (71335-1952-1) 30 tablet2021-09-300000-00-00NoNoCurrent
71335-1952-27133519520290 TABLET in 1 BOTTLE (71335-1952-2) 90 tablet2021-09-300000-00-00NoNoCurrent
71335-1952-37133519520328 TABLET in 1 BOTTLE (71335-1952-3) 28 tablet2021-09-300000-00-00NoNoCurrent
71335-1952-47133519520460 TABLET in 1 BOTTLE (71335-1952-4) 60 tablet2021-09-300000-00-00NoNoCurrent