Fexofenadine HCL

Product NDC
69230-301
11-digit product format
692300301
Labeler code
69230
Product ID
69230-301_eb46135f-d536-4328-96dc-30a2b16fe9d2
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCL
Dosage form
TABLET
Route
ORAL
Labeler
Camber Consumer Care
Application
ANDA204097
Marketing category
ANDA
Marketing start
2016-08-19
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
Rxcui997420, 997501

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
69230-301-01Fexofenadine HCL100 in 1 BOTTLETABLET1003
69230-301-01Fexofenadine HCL1 in 1 CARTONTABLET13
69230-301-30Fexofenadine HCL30 in 1 BOTTLETABLET303
69230-301-30Fexofenadine HCL1 in 1 CARTONTABLET13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69230-301FEXOFENADINE HCL TABLET [CAMBER CONSUMER CARE]3Current NDC, Legacy NDC, 4 package rows20190530_e437655c-f1f3-4b58-89ba-bf22e416d311.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNe437655c-f1f3-4b58-89ba-bf22e416d3113
997501fexofenadine HCl 60 MG Oral TabletPSNe437655c-f1f3-4b58-89ba-bf22e416d3113
997420fexofenadine hydrochloride 180 MG Oral TabletSCDe437655c-f1f3-4b58-89ba-bf22e416d3113
997501fexofenadine hydrochloride 60 MG Oral TabletSCDe437655c-f1f3-4b58-89ba-bf22e416d3113
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYe437655c-f1f3-4b58-89ba-bf22e416d3113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69230-301-01692300301011 BOTTLE in 1 CARTON (69230-301-01) / 100 TABLET in 1 BOTTLE1 bottle2016-08-190000-00-00NoNoCurrent
69230-301-30692300301301 BOTTLE in 1 CARTON (69230-301-30) / 30 TABLET in 1 BOTTLE1 bottle2016-08-190000-00-00NoNoCurrent