FDA.reportPublic FDA data

leader all day allergy

Product NDC
70000-0380
11-digit product format
700000380
Labeler code
70000
Product ID
70000-0380_f547a78c-52a9-40c8-b48c-7e76681b9c5d
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 110, LLC. dba Leader
Application
ANDA078336
Marketing category
ANDA
Marketing start
2018-08-13
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 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
leader all day allergy
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014678

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0380-1leader all day allergy14 in 1 CARTONTABLET, FILM COATED146
70000-0380-1leader all day allergy1 in 1 BLISTER PACKTABLET, FILM COATED16
70000-0380-2leader all day allergy1 in 1 CARTONTABLET, FILM COATED16
70000-0380-2leader all day allergy30 in 1 BOTTLETABLET, FILM COATED306
70000-0380-3leader all day allergy1 in 1 CARTONTABLET, FILM COATED16
70000-0380-3leader all day allergy70 in 1 BOTTLETABLET, FILM COATED706
70000-0380-4leader all day allergy90 in 1 BOTTLETABLET, FILM COATED906
70000-0380-4leader all day allergy1 in 1 CARTONTABLET, FILM COATED16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0380-1EA - Each70000-03804baa9295-b70b-4444-91b6-e87009773b0a12019-02-13
70000-0380-2EA - Each70000-038003104f42-2362-4321-9f00-54d4b1a627fa12019-03-12
70000-0380-3EA - Each70000-03800a95bdfa-3c33-4c12-959f-845c16608f1012019-03-12
70000-0380-4EA - Each70000-03809e798399-20c4-423b-9612-dc63127b973312019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0380LEADER ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH 110, LLC. DBA LEADER]5Current NDC, Legacy NDC, 8 package rows20210618_ce1cef83-e9d1-4cd6-b0e7-b2eb9ce06ddf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNce1cef83-e9d1-4cd6-b0e7-b2eb9ce06ddf6
1014678cetirizine hydrochloride 10 MG Oral TabletSCDce1cef83-e9d1-4cd6-b0e7-b2eb9ce06ddf6
1014678cetirizine HCl 10 MG Oral TabletSYce1cef83-e9d1-4cd6-b0e7-b2eb9ce06ddf6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0380-17000003800114 BLISTER PACK in 1 CARTON (70000-0380-1) / 1 TABLET, FILM COATED in 1 BLISTER PACK14 blister pack2018-08-230000-00-00NoNoCurrent
70000-0380-2700000380021 BOTTLE in 1 CARTON (70000-0380-2) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-08-130000-00-00NoNoCurrent
70000-0380-3700000380031 BOTTLE in 1 CARTON (70000-0380-3) > 70 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-08-130000-00-00NoNoCurrent
70000-0380-4700000380041 BOTTLE in 1 CARTON (70000-0380-4) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-08-130000-00-00NoNoCurrent