Levocetirizine Dihydrochloride

Product NDC
50090-6979
11-digit product format
500906979
Labeler code
50090
Product ID
50090-6979_20e6ad84-17d4-4fb3-aaa1-ee040f102f5b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levocetirizine Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091264
Marketing category
ANDA
Marketing start
2012-06-29
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
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 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
50090-6979-0Levocetirizine Dihydrochloride90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6979-0EA - Each50090-69792e7a65fb-5b0d-45d0-b0bc-da618984065412024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6979LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20231228_7c163007-7e0d-4d55-8ae1-89defe55580f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSN7c163007-7e0d-4d55-8ae1-89defe55580f1
855172levocetirizine dihydrochloride 5 MG Oral TabletSCD7c163007-7e0d-4d55-8ae1-89defe55580f1
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSY7c163007-7e0d-4d55-8ae1-89defe55580f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6979-05009069790090 TABLET in 1 BOTTLE (50090-6979-0) 90 tablet2023-12-26NoNoCurrent