Fexofenadine HCL

Product NDC
0363-6231
11-digit product format
003636231
Labeler code
0363
Product ID
0363-6231_4654a188-db7a-2770-e063-6394a90a278e
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCL
Dosage form
TABLET
Route
ORAL
Labeler
Walgreens
Application
ANDA211075
Marketing category
ANDA
Marketing start
2024-07-23
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
Fexofenadine HCL
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
0363-6231-24Fexofenadine HCL24 in 1 BOTTLETABLET244

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-6231FEXOFENADINE HCL TABLET [WALGREENS]3Current NDC, 1 package rows20241222_0eaf28a5-f8dd-3888-e063-6394a90a8cc6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN0eaf28a5-f8dd-3888-e063-6394a90a8cc64
997420fexofenadine hydrochloride 180 MG Oral TabletSCD0eaf28a5-f8dd-3888-e063-6394a90a8cc64
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY0eaf28a5-f8dd-3888-e063-6394a90a8cc64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-6231-240036362312424 TABLET in 1 BOTTLE (0363-6231-24) 24 tablet2024-07-23NoNoHistorical