FDA.reportPublic FDA data

levocetirizine dihydrochloride

Product NDC
45802-680
11-digit product format
458020680
Labeler code
45802
Product ID
45802-680_1a939b38-64a2-4238-816d-4c01075e5cbe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levocetirizine dihydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA091263
Marketing category
ANDA
Marketing start
2011-11-07
Substance
LEVOCETIRIZINE DIHYDROCHLORIDE
Active strength
.5 mg/mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
levocetirizine dihydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOCETIRIZINE DIHYDROCHLORIDE.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOD6A38AGA
Rxcui855168

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
36cf9111-9cc4-8f59-a74c-0c1cfbd4a760Product name720190702
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-680-28levocetirizine dihydrochloride148 mL in 1 BOTTLESOLUTION14818

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-680-28ML - Milliliter45802-68054726ce9-a98f-4e7b-8355-3a2b4045107712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOCETIRIZINE DIHYDROCHLORIDEACTIVE INGREDIENTSOD6A38AGALEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION [PERRIGO NEW YORK INC]8
LEVOCETIRIZINEACTIVE MOIETY6U5EA9RT2OLEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION [PERRIGO NEW YORK INC]8
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PLEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION [PERRIGO NEW YORK INC]8
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION [PERRIGO NEW YORK INC]8
MALTITOLINACTIVE INGREDIENTD65DG142WKLEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION [PERRIGO NEW YORK INC]8
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION [PERRIGO NEW YORK INC]8
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION [PERRIGO NEW YORK INC]8
SACCHARININACTIVE INGREDIENTFST467XS7DLEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION [PERRIGO NEW YORK INC]8
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BLEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION [PERRIGO NEW YORK INC]8
WATERINACTIVE INGREDIENT059QF0KO0RLEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION [PERRIGO NEW YORK INC]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-680LEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION [PADAGIS ISRAEL PHARMACEUTICALS LTD]16Current NDC, Legacy NDC, 1 package rows20221221_2965ef46-18db-4615-9dce-bfb0f0b3366a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855168levocetirizine dihydrochloride 2.5 MG in 5 mL Oral SolutionPSN628c26f0-f6bb-4658-ba50-8ca04cd859cb108
855168levocetirizine dihydrochloride 0.5 MG/ML Oral SolutionSCD628c26f0-f6bb-4658-ba50-8ca04cd859cb108
855168levocetirizine dihydrochloride 2.5 MG per 5 ML Oral SolutionSY628c26f0-f6bb-4658-ba50-8ca04cd859cb108
855168levocetirizine dihydrochloride 2.5 MG in 5 mL Oral SolutionPSNa9e7152c-0aa3-4355-8805-307e510ac86b100
855168levocetirizine dihydrochloride 0.5 MG/ML Oral SolutionSCDa9e7152c-0aa3-4355-8805-307e510ac86b100
855168levocetirizine dihydrochloride 2.5 MG per 5 ML Oral SolutionSYa9e7152c-0aa3-4355-8805-307e510ac86b100
855168levocetirizine dihydrochloride 2.5 MG in 5 mL Oral SolutionPSN2965ef46-18db-4615-9dce-bfb0f0b3366a18
855168levocetirizine dihydrochloride 0.5 MG/ML Oral SolutionSCD2965ef46-18db-4615-9dce-bfb0f0b3366a18
855168levocetirizine dihydrochloride 2.5 MG per 5 ML Oral SolutionSY2965ef46-18db-4615-9dce-bfb0f0b3366a18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-680-2845802068028148 mL in 1 BOTTLE (45802-680-28) 148 ml2011-11-070000-00-00NoNoCurrent