Allergy Relief

Product NDC
83324-009
11-digit product format
833240009
Labeler code
83324
Product ID
83324-009_fc49fe88-56a3-6dcf-e053-6294a90adb84
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Chain Drug Marketing Association, Inc.
Application
ANDA211075
Marketing category
ANDA
Marketing start
2023-05-22
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
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
83324-009-12Allergy Relief1 in 1 CARTONTABLET12
83324-009-12Allergy Relief12 in 1 BLISTER PACKTABLET122
83324-009-24Allergy Relief12 in 1 BLISTER PACKTABLET122
83324-009-24Allergy Relief2 in 1 CARTONTABLET22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-009ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET [CHAIN DRUG MARKETING ASSOCIATION, INC.]2Current NDC, 4 package rows20230523_fabb8c0d-b4da-ab73-e053-6394a90ab8b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997501fexofenadine HCl 60 MG Oral TabletPSNfabb8c0d-b4da-ab73-e053-6394a90ab8b52
997501fexofenadine hydrochloride 60 MG Oral TabletSCDfabb8c0d-b4da-ab73-e053-6394a90ab8b52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83324-009-12833240009121 BLISTER PACK in 1 CARTON (83324-009-12) / 12 TABLET in 1 BLISTER PACK1 blister pack2023-05-22NoNoCurrent
83324-009-24833240009242 BLISTER PACK in 1 CARTON (83324-009-24) / 12 TABLET in 1 BLISTER PACK2 blister pack2023-05-22NoNoCurrent