12HR Allergy Relief

Product NDC
70000-0586
11-digit product format
700000586
Labeler code
70000
Product ID
70000-0586_ccc271cc-6aa2-f753-e053-2995a90a1161
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
CARDINAL HEALTH
Application
ANDA211075
Marketing category
ANDA
Marketing start
2021-09-24
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
60 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
12HR Allergy Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEXOFENADINE HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S068B75ZU
Rxcui997501

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
70000-0586-112HR Allergy Relief12 in 1 BLISTER PACKTABLET122
70000-0586-112HR Allergy Relief1 in 1 CARTONTABLET12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0586-1EA - Each70000-0586e01b6ea7-fa01-41f9-beb6-562c59d9bfca12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-058612HR ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH]2Current NDC, Legacy NDC, 2 package rows20210925_ea5d0e55-2191-4094-b082-24b317f95752.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997501fexofenadine HCl 60 MG Oral TabletPSNea5d0e55-2191-4094-b082-24b317f957522
997501fexofenadine hydrochloride 60 MG Oral TabletSCDea5d0e55-2191-4094-b082-24b317f957522

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0586-1700000586011 BLISTER PACK in 1 CARTON (70000-0586-1) / 12 TABLET in 1 BLISTER PACK1 blister pack2021-09-240000-00-00NoNoCurrent