Allergy Relief

Product NDC
84324-040
11-digit product format
843240040
Labeler code
84324
Product ID
84324-040_b395f46e-4c20-44f7-8d87-499b016cd1d2
Type
HUMAN OTC DRUG
Nonproprietary name
fexofenadine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NUVICARE LLC
Application
ANDA211075
Marketing category
ANDA
Marketing start
2026-05-22
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
180 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
Allergy Relief
Listing expiration
2027-12-31

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
84324-040-01Allergy Relief4 in 1 BLISTER PACKTABLET41

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN895de6e9-c5b6-42fe-b450-f5d8331ce2e31
997420fexofenadine hydrochloride 180 MG Oral TabletSCD895de6e9-c5b6-42fe-b450-f5d8331ce2e31
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY895de6e9-c5b6-42fe-b450-f5d8331ce2e31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84324-040-01843240040014 TABLET in 1 BLISTER PACK (84324-040-01) 4 tablet2026-05-22NoNoCurrent