FDA.reportPublic FDA data

24HR Allergy Relief

Product NDC
70000-0362
11-digit product format
700000362
Labeler code
70000
Product ID
70000-0362_e888ebac-b741-9f96-5cd8-edfbad1a721d
Type
HUMAN OTC DRUG
Nonproprietary name
levocetirizine dihydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
LEADER/ Cardinal Health 110, Inc.
Application
ANDA210375
Marketing category
ANDA
Marketing start
2018-03-12
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
24HR Allergy Relief
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
70000-0362-124HR Allergy Relief2 in 1 CARTONTABLET, COATED29
70000-0362-124HR Allergy Relief5 in 1 BLISTER PACKTABLET, COATED59
70000-0362-224HR Allergy Relief35 in 1 BOTTLETABLET, COATED359
70000-0362-224HR Allergy Relief1 in 1 CARTONTABLET, COATED19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0362-1EA - Each70000-0362ae14f336-8149-4244-9692-04f6e97785ae12018-11-06
70000-0362-2EA - Each70000-03627278aaf7-6470-4207-88e6-01c13971865612018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-036224HR ALLERGY RELIEF (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET, COATED [LEADER/ CARDINAL HEALTH 110, INC.]7Current NDC, Legacy NDC, 4 package rows20241024_6ba57f12-fd25-c4a6-ff2d-2955116f84c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSN6ba57f12-fd25-c4a6-ff2d-2955116f84c49
855172levocetirizine dihydrochloride 5 MG Oral TabletSCD6ba57f12-fd25-c4a6-ff2d-2955116f84c49
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSY6ba57f12-fd25-c4a6-ff2d-2955116f84c49

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0362-1700000362012 BLISTER PACK in 1 CARTON (70000-0362-1) / 5 TABLET, COATED in 1 BLISTER PACK2 blister pack2018-08-140000-00-00NoNoCurrent
70000-0362-2700000362021 BOTTLE in 1 CARTON (70000-0362-2) / 35 TABLET, COATED in 1 BOTTLE1 bottle2018-03-120000-00-00NoNoCurrent