FDA.reportPublic FDA data

Allegra Allergy

Product NDC
41167-4120
11-digit product format
411674120
Labeler code
41167
Product ID
41167-4120_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
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
41167-4120-0Allegra Allergy1 in 1 CARTONTABLET, FILM COATED164
41167-4120-0Allegra Allergy5 in 1 BLISTER PACKTABLET, FILM COATED564
41167-4120-1Allegra Allergy1 in 1 CARTONTABLET, FILM COATED164
41167-4120-1Allegra Allergy2 in 1 BLISTER PACKTABLET, FILM COATED264
41167-4120-2Allegra Allergy3 in 1 CARTONTABLET, FILM COATED364
41167-4120-2Allegra Allergy5 in 1 BLISTER PACKTABLET, FILM COATED564
41167-4120-3Allegra Allergy30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3064
41167-4120-3Allegra Allergy1 in 1 CARTONTABLET, FILM COATED164
41167-4120-4Allegra Allergy45 in 1 BOTTLE, PLASTICTABLET, FILM COATED4564
41167-4120-4Allegra Allergy1 in 1 CARTONTABLET, FILM COATED164
41167-4120-5Allegra Allergy45 in 1 BOTTLE, PLASTICTABLET, FILM COATED4564
41167-4120-5Allegra Allergy2 in 1 CARTONTABLET, FILM COATED264
41167-4120-6Allegra Allergy70 in 1 BOTTLE, PLASTICTABLET, FILM COATED7064
41167-4120-6Allegra Allergy1 in 1 CARTONTABLET, FILM COATED164

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41167-4120-0EA - Each41167-4120a319bd76-8ddf-44b6-b1cc-2ba117185f6d12012-07-24
41167-4120-2EA - Each41167-412056bcf949-12a0-42c0-b487-9d700456915b12012-07-24
41167-4120-3EA - Each41167-41203a70589e-d283-4343-a1e4-566c12814ee612012-07-24
41167-4120-4EA - Each41167-4120496e2b39-5506-46c2-a111-be6de6cd017612012-07-24
41167-4120-5EA - Each41167-4120dca89411-559c-49cc-903c-a7966c80475e12012-07-24
41167-4120-6EA - Each41167-41203244b127-7096-4dff-9e71-8410ec8d785412012-07-24

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
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET [NAVAJO MANUFACTURING CO., INC.]1
FEXOFENADINEACTIVE MOIETYE6582LOH6VALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET [NAVAJO MANUFACTURING CO., INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET [NAVAJO MANUFACTURING CO., INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET [NAVAJO MANUFACTURING CO., INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET [NAVAJO MANUFACTURING CO., INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET [NAVAJO MANUFACTURING CO., INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET [NAVAJO MANUFACTURING CO., INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET [NAVAJO MANUFACTURING CO., INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET [NAVAJO MANUFACTURING CO., INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET [NAVAJO MANUFACTURING CO., INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-4120ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [CHATTEM, INC.]62Current NDC, Legacy NDC, 14 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
997422Allegra 180 MG Oral TabletPSNe8a00fa1-79af-4ce6-885f-0ce12c5da8368
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNe8a00fa1-79af-4ce6-885f-0ce12c5da8368
997422fexofenadine hydrochloride 180 MG Oral Tablet [Allegra]SBDe8a00fa1-79af-4ce6-885f-0ce12c5da8368
997420fexofenadine hydrochloride 180 MG Oral TabletSCDe8a00fa1-79af-4ce6-885f-0ce12c5da8368
997422Allegra 180 MG Oral TabletSYe8a00fa1-79af-4ce6-885f-0ce12c5da8368
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYe8a00fa1-79af-4ce6-885f-0ce12c5da8368

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-4120-0411674120001 BLISTER PACK in 1 CARTON (41167-4120-0) / 5 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2011-03-030000-00-00NoNoCurrent
41167-4120-1411674120011 BLISTER PACK in 1 CARTON (41167-4120-1) > 2 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2011-03-030000-00-00NoNoCurrent
41167-4120-2411674120023 BLISTER PACK in 1 CARTON (41167-4120-2) / 5 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2011-03-030000-00-00NoNoCurrent
41167-4120-3411674120031 BOTTLE, PLASTIC in 1 CARTON (41167-4120-3) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2011-03-030000-00-00NoNoCurrent
41167-4120-4411674120041 BOTTLE, PLASTIC in 1 CARTON (41167-4120-4) / 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2011-03-030000-00-00NoNoCurrent
41167-4120-5411674120052 BOTTLE, PLASTIC in 1 CARTON (41167-4120-5) > 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2011-03-030000-00-00NoNoCurrent
41167-4120-6411674120061 BOTTLE, PLASTIC in 1 CARTON (41167-4120-6) / 70 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2011-03-030000-00-00NoNoCurrent