Fexofenadine HCL

Product NDC
0363-9765
11-digit product format
003639765
Labeler code
0363
Product ID
0363-9765_296a0f8d-2607-0e02-e063-6394a90a64bd
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCL
Dosage form
TABLET
Route
ORAL
Labeler
Walgreens
Application
ANDA211075
Marketing category
ANDA
Marketing start
2024-02-27
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
60 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 HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S068B75ZU
Rxcui997501

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
0363-9765-24Fexofenadine HCL24 in 1 BLISTER PACKTABLET243

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9765FEXOFENADINE HCL TABLET [WALGREENS]3Current NDC, 1 package rows20241218_fd7920f6-f53e-90cf-e053-6294a90aa8db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997501fexofenadine HCl 60 MG Oral TabletPSNfd7920f6-f53e-90cf-e053-6294a90aa8db3
997501fexofenadine hydrochloride 60 MG Oral TabletSCDfd7920f6-f53e-90cf-e053-6294a90aa8db3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-9765-240036397652424 TABLET in 1 BLISTER PACK (0363-9765-24) 24 tablet2024-02-27NoNoCurrent