FDA.reportPublic FDA data

Levocetirizine Dihydrochloride

Product NDC
49035-492
11-digit product format
490350492
Labeler code
49035
Product ID
49035-492_faf3eee1-908d-7d25-bfaf-14c26daabcf7
Type
HUMAN OTC DRUG
Nonproprietary name
Levocetirizine Dihydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Walmart Inc.
Application
ANDA210375
Marketing category
ANDA
Marketing start
2019-07-26
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
49035-492-10Levocetirizine Dihydrochloride10 in 1 BOTTLETABLET, COATED108
49035-492-10Levocetirizine Dihydrochloride1 in 1 CARTONTABLET, COATED18
49035-492-12Levocetirizine Dihydrochloride1 in 1 CARTONTABLET, COATED18
49035-492-12Levocetirizine Dihydrochloride120 in 1 BOTTLETABLET, COATED1208
49035-492-35Levocetirizine Dihydrochloride35 in 1 BOTTLETABLET, COATED358
49035-492-35Levocetirizine Dihydrochloride1 in 1 BOTTLETABLET, COATED18
49035-492-79Levocetirizine Dihydrochloride5 in 1 BLISTER PACKTABLET, COATED58
49035-492-79Levocetirizine Dihydrochloride2 in 1 BLISTER PACKTABLET, COATED28

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-492LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, COATED [WALMART INC.]6Current NDC, Legacy NDC, 8 package rows20250521_82da5fa1-3633-2c48-32b9-d15482f308a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSN82da5fa1-3633-2c48-32b9-d15482f308a18
855172levocetirizine dihydrochloride 5 MG Oral TabletSCD82da5fa1-3633-2c48-32b9-d15482f308a18
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSY82da5fa1-3633-2c48-32b9-d15482f308a18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-492-10490350492101 BOTTLE in 1 CARTON (49035-492-10) / 10 TABLET, COATED in 1 BOTTLE1 bottle2026-01-15NoNoCurrent
49035-492-12490350492121 BOTTLE in 1 CARTON (49035-492-12) / 120 TABLET, COATED in 1 BOTTLE1 bottle2026-01-15NoNoCurrent
49035-492-35490350492351 BOTTLE in 1 BOTTLE (49035-492-35) / 35 TABLET, COATED in 1 BOTTLE1 bottle2019-07-260000-00-00NoNoCurrent
49035-492-79490350492792 BLISTER PACK in 1 BLISTER PACK (49035-492-79) / 5 TABLET, COATED in 1 BLISTER PACK2 blister pack2019-07-260000-00-00NoNoCurrent