FDA.reportPublic FDA data

Fexofenadine HCL

Product NDC
50090-4070
11-digit product format
500904070
Labeler code
50090
Product ID
50090-4070_eb3a6d4d-e015-4e4c-bc05-2766731c7e70
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCL
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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

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
50090-4070-0Fexofenadine HCL30 in 1 BOTTLETABLET3016
50090-4070-1Fexofenadine HCL90 in 1 BOTTLETABLET9016
50090-4070-2Fexofenadine HCL100 in 1 BOTTLETABLET10016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4070-0EA - Each50090-407033fccd6d-eb25-4ebb-812b-0af52e418b8512022-01-06
50090-4070-1EA - Each50090-40709c8b4ed8-86f4-4af3-b06e-c901f0a8f01612022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4070FEXOFENADINE HCL TABLET [A-S MEDICATION SOLUTIONS]16Current NDC, Legacy NDC, 3 package rows20231216_b420b619-e643-43e6-9b8b-81af11fdd4ed.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4070-05009040700030 TABLET in 1 BOTTLE (50090-4070-0) 30 tablet2019-01-180000-00-00NoNoCurrent
50090-4070-15009040700190 TABLET in 1 BOTTLE (50090-4070-1) 90 tablet2019-01-180000-00-00NoNoCurrent
50090-4070-250090407002100 TABLET in 1 BOTTLE (50090-4070-2) 100 tablet2021-10-040000-00-00NoNoCurrent