FDA.reportPublic FDA data

Non-Drowsy Allergy Relief

Product NDC
11673-621
11-digit product format
116730621
Labeler code
11673
Product ID
11673-621_d7eb1caf-eeff-10b7-c464-3592c8d7d0ee
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
TARGET CORPORATION
Application
ANDA076502
Marketing category
ANDA
Marketing start
2025-08-01
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
Non-Drowsy 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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-621-01Non-Drowsy Allergy Relief150 in 1 BOTTLETABLET1502
11673-621-01Non-Drowsy Allergy Relief1 in 1 CARTONTABLET12
11673-621-15Non-Drowsy Allergy Relief3 in 1 CARTONTABLET32
11673-621-15Non-Drowsy Allergy Relief5 in 1 BLISTER PACKTABLET52
11673-621-30Non-Drowsy Allergy Relief1 in 1 CARTONTABLET12
11673-621-30Non-Drowsy Allergy Relief30 in 1 BOTTLETABLET302
11673-621-50Non-Drowsy Allergy Relief150 in 1 BOTTLETABLET1502
11673-621-70Non-Drowsy Allergy Relief1 in 1 CARTONTABLET12
11673-621-70Non-Drowsy Allergy Relief70 in 1 BOTTLETABLET702

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN3cf4b7fe-b1f7-b767-430a-655408f917532
997420fexofenadine hydrochloride 180 MG Oral TabletSCD3cf4b7fe-b1f7-b767-430a-655408f917532
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY3cf4b7fe-b1f7-b767-430a-655408f917532

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11673-621-01116730621011 BOTTLE in 1 CARTON (11673-621-01) / 150 TABLET in 1 BOTTLE1 bottle2025-08-01NoNoCurrent
11673-621-15116730621153 BLISTER PACK in 1 CARTON (11673-621-15) / 5 TABLET in 1 BLISTER PACK3 blister pack2025-08-01NoNoCurrent
11673-621-30116730621301 BOTTLE in 1 CARTON (11673-621-30) / 30 TABLET in 1 BOTTLE1 bottle2025-08-01NoNoCurrent
11673-621-5011673062150150 TABLET in 1 BOTTLE (11673-621-50) 150 tablet2025-08-01NoNoCurrent
11673-621-70116730621701 BOTTLE in 1 CARTON (11673-621-70) / 70 TABLET in 1 BOTTLE1 bottle2025-08-01NoNoCurrent