Levocetirizine Dihydrochloride

Product NDC
51655-148
11-digit product format
516550148
Labeler code
51655
Product ID
51655-148_499e8a3e-9b27-9655-e063-6294a90a3be8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levocetirizine Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA091264
Marketing category
ANDA
Marketing start
2022-10-04
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
51655-148-52Levocetirizine Dihydrochloride30 in 1 BOTTLE, PLASTICTABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-148LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1Current NDC, 1 package rows20230418_f2b458d6-ac10-0fed-e053-2a95a90a0f9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSNf2b458d6-ac10-0fed-e053-2a95a90a0f9c3
855172levocetirizine dihydrochloride 5 MG Oral TabletSCDf2b458d6-ac10-0fed-e053-2a95a90a0f9c3
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSYf2b458d6-ac10-0fed-e053-2a95a90a0f9c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-148-525165501485230 TABLET in 1 BOTTLE, PLASTIC (51655-148-52) 30 tablet2022-10-04NoNoHistorical