FDA.reportPublic FDA data

Allergy Relief

Product NDC
41250-506
11-digit product format
412500506
Labeler code
41250
Product ID
41250-506_c0c28d44-6450-45e5-b8e2-2ce0de892365
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
MEIJER, INC.
Application
ANDA204507
Marketing category
ANDA
Marketing start
2018-03-31
Marketing end
2026-12-31
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
Allergy Relief
Brand name suffix
non drowsy

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
41250-506-15Allergy Reliefnon drowsy1 in 1 BLISTER PACKTABLET, COATED16
41250-506-15Allergy Reliefnon drowsy15 in 1 CARTONTABLET, COATED156
41250-506-30Allergy Reliefnon drowsy1 in 1 CARTONTABLET, COATED16
41250-506-30Allergy Reliefnon drowsy30 in 1 BOTTLE, PLASTICTABLET, COATED306
41250-506-45Allergy Reliefnon drowsy1 in 1 CARTONTABLET, COATED16
41250-506-45Allergy Reliefnon drowsy45 in 1 BOTTLE, PLASTICTABLET, COATED456
41250-506-90Allergy Reliefnon drowsy90 in 1 BOTTLE, PLASTICTABLET, COATED906
41250-506-90Allergy Reliefnon drowsy1 in 1 CARTONTABLET, COATED16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-506ALLERGY RELIEF NON DROWSY (FEXOFENADINE HCL) TABLET, COATED [MEIJER, INC.]5Current NDC, Legacy NDC, 8 package rows20230803_b3395454-65db-4d8b-abce-2475b049a114.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNb3395454-65db-4d8b-abce-2475b049a1146
997420fexofenadine hydrochloride 180 MG Oral TabletSCDb3395454-65db-4d8b-abce-2475b049a1146
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYb3395454-65db-4d8b-abce-2475b049a1146

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-506-154125005061515 BLISTER PACK in 1 CARTON (41250-506-15) / 1 TABLET, COATED in 1 BLISTER PACK15 blister pack2018-03-312026-12-31NoNoCurrent
41250-506-30412500506301 BOTTLE, PLASTIC in 1 CARTON (41250-506-30) / 30 TABLET, COATED in 1 BOTTLE, PLASTIC2018-03-312026-12-31NoNoCurrent
41250-506-45412500506451 BOTTLE, PLASTIC in 1 CARTON (41250-506-45) / 45 TABLET, COATED in 1 BOTTLE, PLASTIC2018-03-312026-12-31NoNoCurrent
41250-506-90412500506901 BOTTLE, PLASTIC in 1 CARTON (41250-506-90) / 90 TABLET, COATED in 1 BOTTLE, PLASTIC2018-03-312026-12-31NoNoCurrent