FDA.reportPublic FDA data

levocetirizine dihydrochloride

Product NDC
69842-761
11-digit product format
698420761
Labeler code
69842
Product ID
69842-761_7839b2b5-3bfc-0bdc-9a7d-28cfd9ae6fd8
Type
HUMAN OTC DRUG
Nonproprietary name
levocetirizine dihydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
CVS PHARMACY
Application
ANDA210375
Marketing category
ANDA
Marketing start
2018-04-15
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
69842-761-10levocetirizine dihydrochloride2 in 1 CARTONTABLET, COATED213
69842-761-10levocetirizine dihydrochloride5 in 1 BLISTER PACKTABLET, COATED513
69842-761-35levocetirizine dihydrochloride1 in 1 CARTONTABLET, COATED113
69842-761-35levocetirizine dihydrochloride35 in 1 BOTTLETABLET, COATED3513
69842-761-55levocetirizine dihydrochloride55 in 1 BOTTLETABLET, COATED5513
69842-761-55levocetirizine dihydrochloride1 in 1 CARTONTABLET, COATED113
69842-761-80levocetirizine dihydrochloride80 in 1 BOTTLETABLET, COATED8013
69842-761-80levocetirizine dihydrochloride1 in 1 CARTONTABLET, COATED113

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-761LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, COATED [CVS PHARMACY]11Current NDC, Legacy NDC, 8 package rows20231014_c8681ca3-27b4-6738-af72-599ff05f2ec8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSNc8681ca3-27b4-6738-af72-599ff05f2ec813
855172levocetirizine dihydrochloride 5 MG Oral TabletSCDc8681ca3-27b4-6738-af72-599ff05f2ec813
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSYc8681ca3-27b4-6738-af72-599ff05f2ec813

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-761-10698420761102 BLISTER PACK in 1 CARTON (69842-761-10) / 5 TABLET, COATED in 1 BLISTER PACK2 blister pack2018-12-310000-00-00NoNoCurrent
69842-761-35698420761351 BOTTLE in 1 CARTON (69842-761-35) / 35 TABLET, COATED in 1 BOTTLE1 bottle2018-04-150000-00-00NoNoCurrent
69842-761-55698420761551 BOTTLE in 1 CARTON (69842-761-55) / 55 TABLET, COATED in 1 BOTTLE1 bottle2022-11-300000-00-00NoNoCurrent
69842-761-80698420761801 BOTTLE in 1 CARTON (69842-761-80) / 80 TABLET, COATED in 1 BOTTLE1 bottle2018-04-150000-00-00NoNoCurrent