FDA.reportPublic FDA data

Allegra Allergy

Product NDC
66715-9707
11-digit product format
667159707
Labeler code
66715
Product ID
66715-9707_5076f5eb-2ebc-5623-e063-6394a90a3fff
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lil' Drug Store Products, Inc
Application
NDA020872
Marketing category
NDA
Marketing start
2014-09-01
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

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
66715-9707-1Allegra Allergy1 in 1 CARTONTABLET, FILM COATED19
66715-9707-1Allegra Allergy1 in 1 BLISTER PACKTABLET, FILM COATED19
66715-9707-2Allegra Allergy1 in 1 BLISTER PACKTABLET, FILM COATED19
66715-9707-2Allegra Allergy2 in 1 CARTONTABLET, FILM COATED29
66715-9707-8Allegra Allergy5 in 1 CARTONTABLET, FILM COATED59
66715-9707-8Allegra Allergy1 in 1 BLISTER PACKTABLET, FILM COATED19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Fexofenadine HydrochlorideACTIVE INGREDIENT2S068B75ZUALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET [LIL' DRUG STORE PRODUCTS, INC]1
FEXOFENADINEACTIVE MOIETYE6582LOH6VALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET [LIL' DRUG STORE PRODUCTS, INC]1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET [LIL' DRUG STORE PRODUCTS, INC]1
Croscarmellose SodiumINACTIVE INGREDIENTM28OL1HH48ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET [LIL' DRUG STORE PRODUCTS, INC]1
HypromellosesINACTIVE INGREDIENT3NXW29V3WOALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET [LIL' DRUG STORE PRODUCTS, INC]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET [LIL' DRUG STORE PRODUCTS, INC]1
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1AALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET [LIL' DRUG STORE PRODUCTS, INC]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET [LIL' DRUG STORE PRODUCTS, INC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET [LIL' DRUG STORE PRODUCTS, INC]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET [LIL' DRUG STORE PRODUCTS, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-9707ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED ALLEGRA ALLERGY, TRAVEL BASIX (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC]8Current NDC, Legacy NDC, 6 package rows20241121_b82d993a-16ff-4037-a182-7010de8e1cdd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997422Allegra 180 MG Oral TabletPSNb82d993a-16ff-4037-a182-7010de8e1cdd9
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNb82d993a-16ff-4037-a182-7010de8e1cdd9
997422fexofenadine hydrochloride 180 MG Oral Tablet [Allegra]SBDb82d993a-16ff-4037-a182-7010de8e1cdd9
997420fexofenadine hydrochloride 180 MG Oral TabletSCDb82d993a-16ff-4037-a182-7010de8e1cdd9
997422Allegra 180 MG Oral TabletSYb82d993a-16ff-4037-a182-7010de8e1cdd9
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYb82d993a-16ff-4037-a182-7010de8e1cdd9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66715-9707-1667159707011 BLISTER PACK in 1 CARTON (66715-9707-1) / 1 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2018-11-010000-00-00NoNoCurrent
66715-9707-2667159707022 BLISTER PACK in 1 CARTON (66715-9707-2) / 1 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2018-11-010000-00-00NoNoCurrent
66715-9707-8667159707085 BLISTER PACK in 1 CARTON (66715-9707-8) / 1 TABLET, FILM COATED in 1 BLISTER PACK5 blister pack2018-11-010000-00-00NoNoCurrent