FDA.reportPublic FDA data

Allegra Allergy

Product NDC
41167-4124
11-digit product format
411674124
Labeler code
41167
Product ID
41167-4124_fb8ea8ca-b8a9-46af-9c21-d2df1100e9ff
Type
HUMAN OTC DRUG
Nonproprietary name
fexofenadine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chattem, Inc.
Application
NDA020872
Marketing category
NDA
Marketing start
2020-10-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Allegra Allergy
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-4124-0Allegra Allergy90 in 1 BOTTLETABLET, FILM COATED9064
41167-4124-0Allegra Allergy1 in 1 CARTONTABLET, FILM COATED164
41167-4124-3Allegra Allergy2 in 1 PACKAGETABLET, FILM COATED264
41167-4124-5Allegra Allergy55 in 1 BOTTLETABLET, FILM COATED5564
41167-4124-7Allegra Allergy84 in 1 BOTTLETABLET, FILM COATED8464
41167-4124-7Allegra Allergy1 in 1 CARTONTABLET, FILM COATED164
41167-4124-8Allegra Allergy1 in 1 CARTONTABLET, FILM COATED164
41167-4124-8Allegra Allergy100 in 1 BOTTLETABLET, FILM COATED10064

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41167-4124-0EA - Each41167-4124d0d30baa-eca0-4e55-860a-4f0cc7069c9a12022-09-12
41167-4124-3EA - Each41167-41248cb7279c-fe40-4a52-85a4-50def71f52ce12023-03-13
41167-4124-7EA - Each41167-41245cd50192-8f0e-404f-99cd-bd64b88033a212022-09-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [CHATTEM, INC.]29
FEXOFENADINEACTIVE MOIETYE6582LOH6VALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [CHATTEM, INC.]29
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [CHATTEM, INC.]29
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [CHATTEM, INC.]29
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [CHATTEM, INC.]29
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [CHATTEM, INC.]29
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [CHATTEM, INC.]29
POVIDONESINACTIVE INGREDIENTFZ989GH94EALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [CHATTEM, INC.]29
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [CHATTEM, INC.]29
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [CHATTEM, INC.]29
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [CHATTEM, INC.]29

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-4124ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [CHATTEM, INC.]62Current NDC, Legacy NDC, 8 package rows20241116_81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd173.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997422Allegra 180 MG Oral TabletPSN81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd17364
997502Allegra Allergy 60 MG Oral TabletPSN81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd17364
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd17364
997501fexofenadine HCl 60 MG Oral TabletPSN81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd17364
997422fexofenadine hydrochloride 180 MG Oral Tablet [Allegra]SBD81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd17364
997502fexofenadine hydrochloride 60 MG Oral Tablet [Allegra]SBD81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd17364
997420fexofenadine hydrochloride 180 MG Oral TabletSCD81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd17364
997501fexofenadine hydrochloride 60 MG Oral TabletSCD81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd17364
997422Allegra 180 MG Oral TabletSY81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd17364
997502Allegra 60 MG Oral TabletSY81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd17364
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd17364

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-4124-0411674124001 BOTTLE in 1 CARTON (41167-4124-0) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-12-010000-00-00NoNoCurrent
41167-4124-3411674124032 BOTTLE in 1 PACKAGE (41167-4124-3) / 55 TABLET, FILM COATED in 1 BOTTLE (41167-4124-5) 2 bottle2020-10-010000-00-00NoNoCurrent
41167-4124-54116741240555 in 1 BOTTLEHistorical
41167-4124-7411674124071 BOTTLE in 1 CARTON (41167-4124-7) > 84 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-02-010000-00-00NoNoCurrent
41167-4124-8411674124081 BOTTLE in 1 CARTON (41167-4124-8) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-05-010000-00-00NoNoCurrent