FDA.reportPublic FDA data

Fexofenadine HCL

Product NDC
69230-300
11-digit product format
692300300
Labeler code
69230
Product ID
69230-300_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
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 HCL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEXOFENADINE HYDROCHLORIDE180 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
69230-300-01Fexofenadine HCL1 in 1 CARTONTABLET13
69230-300-01Fexofenadine HCL100 in 1 BOTTLETABLET1003
69230-300-05Fexofenadine HCL500 in 1 BOTTLETABLET5003
69230-300-30Fexofenadine HCL30 in 1 BOTTLETABLET303
69230-300-30Fexofenadine HCL1 in 1 CARTONTABLET13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69230-300-01EA - Each69230-300ed263974-8cdb-44b0-8188-4e93e23e1f9012019-03-12
69230-300-05EA - Each69230-3007f850864-2586-4f99-bee1-a64ff744fc3312019-04-11
69230-300-30EA - Each69230-300752dfd0f-5625-4f3f-bd24-f82e34ca485012019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69230-300FEXOFENADINE HCL TABLET [CAMBER CONSUMER CARE]3Current NDC, Legacy NDC, 5 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 TabletPSNb420b619-e643-43e6-9b8b-81af11fdd4ed16
997420fexofenadine hydrochloride 180 MG Oral TabletSCDb420b619-e643-43e6-9b8b-81af11fdd4ed16
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYb420b619-e643-43e6-9b8b-81af11fdd4ed16
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN67679801-a8fe-4038-be71-96e1312badab8
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNa96e6e63-3be9-4e89-ae45-b74b378997b18
997420fexofenadine hydrochloride 180 MG Oral TabletSCD67679801-a8fe-4038-be71-96e1312badab8
997420fexofenadine hydrochloride 180 MG Oral TabletSCDa96e6e63-3be9-4e89-ae45-b74b378997b18
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY67679801-a8fe-4038-be71-96e1312badab8
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYa96e6e63-3be9-4e89-ae45-b74b378997b18
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN852c8ad2-fc7d-4728-b2c6-f64b960fe2ab6
997420fexofenadine hydrochloride 180 MG Oral TabletSCD852c8ad2-fc7d-4728-b2c6-f64b960fe2ab6
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY852c8ad2-fc7d-4728-b2c6-f64b960fe2ab6
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNf9a7e836-6055-484f-a197-1812204285743
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNf7584431-11aa-8213-e053-6294a90a15853
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
997420fexofenadine hydrochloride 180 MG Oral TabletSCDf7584431-11aa-8213-e053-6294a90a15853
997420fexofenadine hydrochloride 180 MG Oral TabletSCDf9a7e836-6055-484f-a197-1812204285743
997501fexofenadine hydrochloride 60 MG Oral TabletSCDe437655c-f1f3-4b58-89ba-bf22e416d3113
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYe437655c-f1f3-4b58-89ba-bf22e416d3113
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYf7584431-11aa-8213-e053-6294a90a15853
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYf9a7e836-6055-484f-a197-1812204285743
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN6bc92969-0d06-4bf5-a634-80964464546c2
997420fexofenadine hydrochloride 180 MG Oral TabletSCD6bc92969-0d06-4bf5-a634-80964464546c2
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY6bc92969-0d06-4bf5-a634-80964464546c2
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN353323b7-67ce-7ce6-e063-6394a90a77d41
997420fexofenadine hydrochloride 180 MG Oral TabletSCD353323b7-67ce-7ce6-e063-6394a90a77d41
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY353323b7-67ce-7ce6-e063-6394a90a77d41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69230-300-00692300300003 BAG in 1 DRUM (69230-300-00) / 10000 TABLET in 1 BAG3 bag19-AUG-16Current
69230-300-01692300300011 BOTTLE in 1 CARTON (69230-300-01) / 100 TABLET in 1 BOTTLE1 bottle2016-08-190000-00-00NoNoCurrent
69230-300-0569230030005500 TABLET in 1 BOTTLE (69230-300-05) 500 tablet2016-08-190000-00-00NoNoCurrent
69230-300-30692300300301 BOTTLE in 1 CARTON (69230-300-30) / 30 TABLET in 1 BOTTLE1 bottle2016-08-190000-00-00NoNoCurrent