Allergy Relief

Product NDC
61504-192
11-digit product format
615040192
Labeler code
61504
Product ID
61504-192_092d5198-d6e3-10b7-e063-6294a90ac4d8
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
AMERIFOODS TRADING COMPANY
Application
ANDA211075
Marketing category
ANDA
Marketing start
2023-10-30
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
180 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
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 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
61504-192-03Allergy Relief5 in 1 BLISTER PACKTABLET52
61504-192-03Allergy Relief3 in 1 CARTONTABLET32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61504-192ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET [AMERIFOODS TRADING COMPANY]2Current NDC, 2 package rows20231103_f6dc0893-b81b-4f96-e053-6294a90a856f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNf6dc0893-b81b-4f96-e053-6294a90a856f2
997420fexofenadine hydrochloride 180 MG Oral TabletSCDf6dc0893-b81b-4f96-e053-6294a90a856f2
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYf6dc0893-b81b-4f96-e053-6294a90a856f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61504-192-03615040192033 BLISTER PACK in 1 CARTON (61504-192-03) / 5 TABLET in 1 BLISTER PACK3 blister pack2023-10-30NoNoHistorical