FDA.reportPublic FDA data

Fexofenadine Hydrochloride

Product NDC
63868-025
11-digit product format
638680025
Labeler code
63868
Product ID
63868-025_b1eeea1a-04f8-d205-fe4a-13699ea6bb47
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Chain Drug Marketing Associate
Application
ANDA076502
Marketing category
ANDA
Marketing start
2014-04-01
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
Fexofenadine Hydrochloride
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
63868-025-30Fexofenadine Hydrochloride30 in 1 BOTTLETABLET303
63868-025-30Fexofenadine Hydrochloride1 in 1 CARTONTABLET13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Fexofenadine HydrochlorideACTIVE INGREDIENT2S068B75ZUFEXOFENADINE HYDROCHLORIDE TABLET [CHAIN DRUG MARKETING ASSOCIATE]1
FEXOFENADINEACTIVE MOIETYE6582LOH6VFEXOFENADINE HYDROCHLORIDE TABLET [CHAIN DRUG MARKETING ASSOCIATE]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FEXOFENADINE HYDROCHLORIDE TABLET [CHAIN DRUG MARKETING ASSOCIATE]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFEXOFENADINE HYDROCHLORIDE TABLET [CHAIN DRUG MARKETING ASSOCIATE]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357FEXOFENADINE HYDROCHLORIDE TABLET [CHAIN DRUG MARKETING ASSOCIATE]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6FEXOFENADINE HYDROCHLORIDE TABLET [CHAIN DRUG MARKETING ASSOCIATE]1
magnesium stearateINACTIVE INGREDIENT70097M6I30FEXOFENADINE HYDROCHLORIDE TABLET [CHAIN DRUG MARKETING ASSOCIATE]1
mannitolINACTIVE INGREDIENT3OWL53L36AFEXOFENADINE HYDROCHLORIDE TABLET [CHAIN DRUG MARKETING ASSOCIATE]1
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQFEXOFENADINE HYDROCHLORIDE TABLET [CHAIN DRUG MARKETING ASSOCIATE]1
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MFEXOFENADINE HYDROCHLORIDE TABLET [CHAIN DRUG MARKETING ASSOCIATE]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FEXOFENADINE HYDROCHLORIDE TABLET [CHAIN DRUG MARKETING ASSOCIATE]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFEXOFENADINE HYDROCHLORIDE TABLET [CHAIN DRUG MARKETING ASSOCIATE]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFEXOFENADINE HYDROCHLORIDE TABLET [CHAIN DRUG MARKETING ASSOCIATE]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-025FEXOFENADINE HYDROCHLORIDE TABLET [CHAIN DRUG MARKETING ASSOCIATE]3Current NDC, Legacy NDC, 2 package rows20230628_8a1de8a1-808a-bc08-6c74-957d6f388eab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN8a1de8a1-808a-bc08-6c74-957d6f388eab3
997420fexofenadine hydrochloride 180 MG Oral TabletSCD8a1de8a1-808a-bc08-6c74-957d6f388eab3
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY8a1de8a1-808a-bc08-6c74-957d6f388eab3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-025-30638680025301 BOTTLE in 1 CARTON (63868-025-30) / 30 TABLET in 1 BOTTLE1 bottle2014-04-010000-00-00NoNoCurrent