levocetirizine dihydrochloride

Product NDC
51407-892
11-digit product format
514070892
Labeler code
51407
Product ID
51407-892_45b17ed5-6ba3-cfa8-e063-6294a90adfb8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levocetirizine dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
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
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
51407-892-90levocetirizine dihydrochloride90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-892-90EA - Each51407-8927b1ff782-eeee-407f-9c0a-4d0b03a91ba912024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-892LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1Current NDC, 1 package rows20240418_163dcce7-4535-a596-e063-6394a90a634f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSN163dcce7-4535-a596-e063-6394a90a634f2
855172levocetirizine dihydrochloride 5 MG Oral TabletSCD163dcce7-4535-a596-e063-6394a90a634f2
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSY163dcce7-4535-a596-e063-6394a90a634f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51407-892-905140708929090 TABLET in 1 BOTTLE (51407-892-90) 90 tablet2024-03-15NoNoHistorical