Allergy Relief

Product NDC
37808-571
11-digit product format
378080571
Labeler code
37808
Product ID
37808-571_0e4ad335-1644-4143-84f3-acccf9bc84f9
Type
HUMAN OTC DRUG
Nonproprietary name
fexofenadine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H E B
Application
ANDA076447
Marketing category
ANDA
Marketing start
2011-06-22
Marketing end
0000-00-00
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
180 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37808-571-22EA - Each37808-571656ff02f-a0fc-44ee-8abc-da66b6cdc77612022-06-06
37808-571-39EA - Each37808-57187d224e7-3cdb-480a-925f-5c618635bbf712022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]3
FEXOFENADINEACTIVE MOIETYE6582LOH6VALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-571ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]7Legacy NDC20211115_5bd44447-3c29-40ee-8326-cf7092464c89.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-571-223780805712215 BLISTER PACK in 1 CARTON (37808-571-22) > 1 TABLET, FILM COATED in 1 BLISTER PACK15 blister pack2011-06-220000-00-00NoNoCurrent
37808-571-39378080571391 BOTTLE in 1 CARTON (37808-571-39) > 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2012-10-010000-00-00NoNoCurrent
37808-571-49378080571491 BOTTLE in 1 CARTON (37808-571-49) > 40 TABLET, FILM COATED in 1 BOTTLE1 bottle2015-03-190000-00-00NoNoCurrent
37808-571-95378080571951 BOTTLE in 1 CARTON (37808-571-95) > 45 TABLET, FILM COATED in 1 BOTTLE1 bottle2012-10-010000-00-00NoNoCurrent