FDA.reportPublic FDA data

levocetirizine dihydrochloride

Product NDC
71335-2283
11-digit product format
713352283
Labeler code
71335
Product ID
71335-2283_126ac3f1-d0d2-4166-9727-a13d3f728447
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
71335-2283-1levocetirizine dihydrochloride10 in 1 BOTTLETABLET10101
71335-2283-2levocetirizine dihydrochloride35 in 1 BOTTLETABLET35101
71335-2283-3levocetirizine dihydrochloride5 in 1 BOTTLETABLET5101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2283-1EA - Each71335-228346ceec34-dcec-4a24-b7d8-e0801c86f20112024-01-04
71335-2283-2EA - Each71335-22833f21d8bc-eab7-4a56-a4d8-1ede45b9f0ba12024-01-04
71335-2283-3EA - Each71335-228359d7ab72-84e5-454e-b1dc-978c9f702a2912024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2283LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]100Current NDC, 3 package rows20231205_be58ca52-ab5d-4656-bfe0-bd5766235968.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSNbe58ca52-ab5d-4656-bfe0-bd5766235968101
855172levocetirizine dihydrochloride 5 MG Oral TabletSCDbe58ca52-ab5d-4656-bfe0-bd5766235968101
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSYbe58ca52-ab5d-4656-bfe0-bd5766235968101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2283-17133522830110 TABLET in 1 BOTTLE (71335-2283-1) 10 tablet2023-11-30NoNoHistorical
71335-2283-27133522830235 TABLET in 1 BOTTLE (71335-2283-2) 35 tablet2023-11-30NoNoHistorical
71335-2283-3713352283035 TABLET in 1 BOTTLE (71335-2283-3) 5 tablet2023-11-30NoNoHistorical