FDA.reportPublic FDA data

Allegra Allergy

Product NDC
41167-4131
11-digit product format
411674131
Labeler code
41167
Product ID
41167-4131_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
2011-03-03
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
60 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 HYDROCHLORIDE60 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
41167-4131-2Allegra Allergy1 in 1 CARTONTABLET, FILM COATED164
41167-4131-2Allegra Allergy12 in 1 BLISTER PACKTABLET, FILM COATED1264
41167-4131-4Allegra Allergy2 in 1 CARTONTABLET, FILM COATED264
41167-4131-4Allegra Allergy12 in 1 BLISTER PACKTABLET, FILM COATED1264
41167-4131-6Allegra Allergy12 in 1 BLISTER PACKTABLET, FILM COATED1264
41167-4131-6Allegra Allergy3 in 1 CARTONTABLET, FILM COATED364

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41167-4131-2EA - Each41167-4131f40b438f-4e9c-42a9-bed9-1b1e1cc0924812012-07-24
41167-4131-4EA - Each41167-4131f4b5b52c-1585-4aab-b8f0-d93706d2637112015-03-03

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
41167-4131ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [CHATTEM, INC.]62Current NDC, Legacy NDC, 6 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
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-4131-2411674131021 BLISTER PACK in 1 CARTON (41167-4131-2) / 12 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2011-03-030000-00-00NoNoCurrent
41167-4131-4411674131042 BLISTER PACK in 1 CARTON (41167-4131-4) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2011-03-030000-00-00NoNoCurrent
41167-4131-6411674131063 BLISTER PACK in 1 CARTON (41167-4131-6) / 12 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2019-03-020000-00-00NoNoCurrent