FDA.reportPublic FDA data

Fexofenadine Hydrochloride

Product NDC
68016-995
11-digit product format
680160995
Labeler code
68016
Product ID
68016-995_9cb9fb1e-0d5d-763a-4950-4b0d53a5b9ee
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Chain Drug Consortium, LLC
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
68016-995-03Fexofenadine Hydrochloride1 in 1 CARTONTABLET13
68016-995-03Fexofenadine Hydrochloride30 in 1 BOTTLETABLET303
68016-995-45Fexofenadine Hydrochloride1 in 1 CARTONTABLET13
68016-995-45Fexofenadine Hydrochloride45 in 1 BOTTLETABLET453

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-995-03EA - Each68016-995a8b3a904-33dd-476d-a38a-bd3191813b7912022-06-06
68016-995-45EA - Each68016-995c3ecd5c2-2678-47cd-b414-78de9e82890d12022-06-06

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-995FEXOFENADINE HYDROCHLORIDE TABLET [CHAIN DRUG CONSORTIUM, LLC ]3Current NDC, Legacy NDC, 4 package rows20230628_d1d8d0ec-2bdd-fb07-a051-d6353e3c240c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNd1d8d0ec-2bdd-fb07-a051-d6353e3c240c3
997420fexofenadine hydrochloride 180 MG Oral TabletSCDd1d8d0ec-2bdd-fb07-a051-d6353e3c240c3
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYd1d8d0ec-2bdd-fb07-a051-d6353e3c240c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-995-03680160995031 BOTTLE in 1 CARTON (68016-995-03) / 30 TABLET in 1 BOTTLE1 bottle2014-04-010000-00-00NoNoCurrent
68016-995-45680160995451 BOTTLE in 1 CARTON (68016-995-45) / 45 TABLET in 1 BOTTLE1 bottle2014-04-010000-00-00NoNoCurrent