FDA.reportPublic FDA data

levocetirizine dihydrochloride

Product NDC
63629-2533
11-digit product format
636292533
Labeler code
63629
Product ID
63629-2533_acc7fd37-12cc-4319-ac53-eb35e3e18d04
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levocetirizine dihydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Bryant Ranch Prepack
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
63629-2533-1levocetirizine dihydrochloride148 mL in 1 BOTTLESOLUTION148108
63629-2533-1levocetirizine dihydrochloride1 in 1 CARTONSOLUTION1108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2533-1ML - Milliliter63629-2533575ef39e-8c96-4833-a105-cac89b8b143612021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2533LEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION [BRYANT RANCH PREPACK]108Current NDC, Legacy NDC, 2 package rows20240921_628c26f0-f6bb-4658-ba50-8ca04cd859cb.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2533-1636292533011 BOTTLE in 1 CARTON (63629-2533-1) / 148 mL in 1 BOTTLE1 bottle2011-11-070000-00-00NoNoCurrent