FDA.reportPublic FDA data

24HR Allergy Relief

Product NDC
70000-0361
11-digit product format
700000361
Labeler code
70000
Product ID
70000-0361_e4cfe55e-fa2e-68d7-d5d0-36e492c9b89e
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
LEADER/ Cardinal Health 110, Inc.
Application
ANDA076502
Marketing category
ANDA
Marketing start
2018-04-27
Marketing end
2026-06-30
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
180 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
24HR Allergy Relief

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEXOFENADINE HYDROCHLORIDE180 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S068B75ZU
Rxcui997420

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0361-124HR Allergy Relief3 in 1 CARTONTABLET36
70000-0361-124HR Allergy Relief5 in 1 BLISTER PACKTABLET56
70000-0361-224HR Allergy Relief30 in 1 BOTTLETABLET306
70000-0361-224HR Allergy Relief1 in 1 CARTONTABLET16
70000-0361-324HR Allergy Relief1 in 1 CARTONTABLET16
70000-0361-324HR Allergy Relief70 in 1 BOTTLETABLET706
70000-0361-424HR Allergy Relief90 in 1 BOTTLETABLET906
70000-0361-424HR Allergy Relief1 in 1 CARTONTABLET16
70000-0361-524HR Allergy Relief180 in 1 BOTTLETABLET1806
70000-0361-524HR Allergy Relief1 in 1 CARTONTABLET16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0361-1EA - Each70000-0361b0ad6c9e-f7fc-48d7-9460-52032f3a618812018-11-06
70000-0361-2EA - Each70000-03615c9f344e-c7d4-4255-9d2c-3e65d77813ff12018-09-05
70000-0361-3EA - Each70000-0361bc6c94a1-48f2-4f63-bacb-4e79f2808e2112018-09-05
70000-0361-4EA - Each70000-0361f2b2fcc5-d484-47a1-b8fb-e04a7c6b630812018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-036124HR ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET [LEADER/ CARDINAL HEALTH 110, INC.]5Current NDC, Legacy NDC, 10 package rows20230628_8917abc8-d391-89d1-ef3b-19e1702bc83d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN8917abc8-d391-89d1-ef3b-19e1702bc83d6
997420fexofenadine hydrochloride 180 MG Oral TabletSCD8917abc8-d391-89d1-ef3b-19e1702bc83d6
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY8917abc8-d391-89d1-ef3b-19e1702bc83d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0361-1700000361013 BLISTER PACK in 1 CARTON (70000-0361-1) / 5 TABLET in 1 BLISTER PACK3 blister pack2018-04-272026-05-31NoNoCurrent
70000-0361-2700000361021 BOTTLE in 1 CARTON (70000-0361-2) / 30 TABLET in 1 BOTTLE1 bottle2018-04-272026-06-30NoNoCurrent
70000-0361-3700000361031 BOTTLE in 1 CARTON (70000-0361-3) / 70 TABLET in 1 BOTTLE1 bottle2018-04-272026-05-31NoNoCurrent
70000-0361-4700000361041 BOTTLE in 1 CARTON (70000-0361-4) / 90 TABLET in 1 BOTTLE1 bottle2018-04-272026-06-30NoNoCurrent
70000-0361-5700000361051 BOTTLE in 1 CARTON (70000-0361-5) / 180 TABLET in 1 BOTTLE1 bottle2020-04-232026-06-30NoNoCurrent