Fexofenadine HCL

Product NDC
50090-4267
11-digit product format
500904267
Labeler code
50090
Product ID
50090-4267_c115219c-8a17-490e-8705-bbce300ff40f
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4267-02023-02-06C16284748780-1f386c64a-2a82-0266-e053-dadaa90a7c1aFexofenadine Hydrochloride Tablets USP, 180 mg
50090-4267-02023-01-30C16284748780-1f386c64a-2a82-0266-e053-dadaa90a7c1aFexofenadine Hydrochloride Tablets USP, 180 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4267-0Fexofenadine HCL30 in 1 BOTTLETABLET308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4267-0EA - Each50090-4267f5f69317-f12c-4628-8700-1769f716a21312022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4267FEXOFENADINE HCL TABLET [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 1 package rows20231024_a96e6e63-3be9-4e89-ae45-b74b378997b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNa96e6e63-3be9-4e89-ae45-b74b378997b18
997420fexofenadine hydrochloride 180 MG Oral TabletSCDa96e6e63-3be9-4e89-ae45-b74b378997b18
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYa96e6e63-3be9-4e89-ae45-b74b378997b18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4267-05009042670030 TABLET in 1 BOTTLE (50090-4267-0) 30 tablet2019-04-180000-00-00NoNoCurrent