FDA.reportPublic FDA data

Fexofenadine Hydrochloride

Product NDC
68196-107
11-digit product format
681960107
Labeler code
68196
Product ID
68196-107_573483c1-14c7-7ff1-a6ee-2d01a988333a
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Sam's West Inc.
Application
ANDA076502
Marketing category
ANDA
Marketing start
2017-05-09
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
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
68196-107-15Fexofenadine Hydrochloride1 in 1 CARTONTABLET12
68196-107-15Fexofenadine Hydrochloride150 in 1 BOTTLETABLET1502
68196-107-50Fexofenadine Hydrochloride150 in 1 BOTTLETABLET1502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-107FEXOFENADINE HYDROCHLORIDE TABLET [SAM'S WEST INC.]2Current NDC, Legacy NDC, 3 package rows20230119_1c1f43c4-7128-37c4-83fe-7eefac3fd477.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN1c1f43c4-7128-37c4-83fe-7eefac3fd4772
997420fexofenadine hydrochloride 180 MG Oral TabletSCD1c1f43c4-7128-37c4-83fe-7eefac3fd4772
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY1c1f43c4-7128-37c4-83fe-7eefac3fd4772

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68196-107-15681960107151 BOTTLE in 1 CARTON (68196-107-15) / 150 TABLET in 1 BOTTLE1 bottle2017-05-090000-00-00NoNoCurrent
68196-107-5068196010750150 TABLET in 1 BOTTLE (68196-107-50) 150 tablet2023-04-01NoNoCurrent