levocetirizine dihydrochloride

Product NDC
72162-1525
11-digit product format
721621525
Labeler code
72162
Product ID
72162-1525_1f34182b-ed7d-4f7e-b87d-54987719d63c
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
72162-1525-3levocetirizine dihydrochloride30 in 1 BOTTLETABLET30101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1525-3EA - Each72162-1525d34f5096-1460-4e84-9c0e-30bbf37d062f12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1525LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20240207_c79d3668-5243-4627-ad2b-cc7c045df120.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSNc79d3668-5243-4627-ad2b-cc7c045df120101
855172levocetirizine dihydrochloride 5 MG Oral TabletSCDc79d3668-5243-4627-ad2b-cc7c045df120101
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSYc79d3668-5243-4627-ad2b-cc7c045df120101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1525-37216215250330 TABLET in 1 BOTTLE (72162-1525-3) 30 tablet2014-09-09NoNoHistorical