FDA.reportPublic FDA data

ALLEGRA ALLERGY

Product NDC
50090-1234
11-digit product format
500901234
Labeler code
50090
Product ID
50090-1234_9840fda7-e713-4573-8029-046a50c67462
Type
HUMAN OTC DRUG
Nonproprietary name
fexofenadine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA020872
Marketing category
NDA
Marketing start
2011-03-03
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
ALLEGRA ALLERGY
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEXOFENADINE HYDROCHLORIDE180 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S068B75ZU
Rxcui997420, 997422, 997501, 997502

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
50090-1234-02023-02-06C16284748780-1f386c649-f187-0266-e053-dadaa90a7c1aALLEGRA ALLERGY
50090-1234-02023-01-30C16284748780-1f386c649-f187-0266-e053-dadaa90a7c1aALLEGRA ALLERGY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1234-0ALLEGRA ALLERGY30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3024
50090-1234-0ALLEGRA ALLERGY1 in 1 CARTONTABLET, FILM COATED124

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1234-0EA - Each50090-1234cf39ccac-8da4-4e2a-9a77-a4d90a8e9d7c12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1234ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]24Current NDC, Legacy NDC, 2 package rows20240731_b5ce28f8-f6c3-4113-9317-e1c98e5030ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997422Allegra 180 MG Oral TabletPSNb5ce28f8-f6c3-4113-9317-e1c98e5030ef24
997502Allegra Allergy 60 MG Oral TabletPSNb5ce28f8-f6c3-4113-9317-e1c98e5030ef24
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNb5ce28f8-f6c3-4113-9317-e1c98e5030ef24
997501fexofenadine HCl 60 MG Oral TabletPSNb5ce28f8-f6c3-4113-9317-e1c98e5030ef24
997422fexofenadine hydrochloride 180 MG Oral Tablet [Allegra]SBDb5ce28f8-f6c3-4113-9317-e1c98e5030ef24
997502fexofenadine hydrochloride 60 MG Oral Tablet [Allegra]SBDb5ce28f8-f6c3-4113-9317-e1c98e5030ef24
997420fexofenadine hydrochloride 180 MG Oral TabletSCDb5ce28f8-f6c3-4113-9317-e1c98e5030ef24
997501fexofenadine hydrochloride 60 MG Oral TabletSCDb5ce28f8-f6c3-4113-9317-e1c98e5030ef24
997422Allegra 180 MG Oral TabletSYb5ce28f8-f6c3-4113-9317-e1c98e5030ef24
997502Allegra 60 MG Oral TabletSYb5ce28f8-f6c3-4113-9317-e1c98e5030ef24
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYb5ce28f8-f6c3-4113-9317-e1c98e5030ef24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1234-0500901234001 BOTTLE, PLASTIC in 1 CARTON (50090-1234-0) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2014-11-280000-00-00NoNoCurrent