FDA.reportPublic FDA data

up and up allergy relief

Product NDC
11673-571
11-digit product format
116730571
Labeler code
11673
Product ID
11673-571_bd94388d-6d57-4b0e-8774-976d4ef0ec9c
Type
HUMAN OTC DRUG
Nonproprietary name
fexofenadine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Target Corporation
Application
ANDA076447
Marketing category
ANDA
Marketing start
2011-04-13
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11673-571-012024-01-30C16284748780-11030e365-2de5-111a-e063-dadaa90a10e2Target Corporation Allergy Relief Drug Facts
11673-571-222024-01-30C16284748780-11030e365-2de5-111a-e063-dadaa90a10e2Target Corporation Allergy Relief Drug Facts
11673-571-332024-01-30C16284748780-11030e365-2de5-111a-e063-dadaa90a10e2Target Corporation Allergy Relief Drug Facts
11673-571-392024-01-30C16284748780-11030e365-2de5-111a-e063-dadaa90a10e2Target Corporation Allergy Relief Drug Facts
11673-571-472024-01-30C16284748780-11030e365-2de5-111a-e063-dadaa90a10e2Target Corporation Allergy Relief Drug Facts
11673-571-492024-01-30C16284748780-11030e365-2de5-111a-e063-dadaa90a10e2Target Corporation Allergy Relief Drug Facts
11673-571-752024-01-30C16284748780-11030e365-2de5-111a-e063-dadaa90a10e2Target Corporation Allergy Relief Drug Facts
11673-571-762024-01-30C16284748780-11030e365-2de5-111a-e063-dadaa90a10e2Target Corporation Allergy Relief Drug Facts
11673-571-872024-01-30C16284748780-11030e365-2de5-111a-e063-dadaa90a10e2Target Corporation Allergy Relief Drug Facts
11673-571-952024-01-30C16284748780-11030e365-2de5-111a-e063-dadaa90a10e2Target Corporation Allergy Relief Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-571-01up and up allergy relief70 in 1 BOTTLETABLET, FILM COATED7010
11673-571-01up and up allergy relief1 in 1 CARTONTABLET, FILM COATED110
11673-571-22up and up allergy relief15 in 1 CARTONTABLET, FILM COATED1510
11673-571-22up and up allergy relief1 in 1 BLISTER PACKTABLET, FILM COATED110
11673-571-33up and up allergy relief60 in 1 BOTTLETABLET, FILM COATED6010
11673-571-39up and up allergy relief30 in 1 BOTTLETABLET, FILM COATED3010
11673-571-39up and up allergy relief1 in 1 CARTONTABLET, FILM COATED110
11673-571-47up and up allergy relief1 in 1 CARTONTABLET, FILM COATED110
11673-571-47up and up allergy relief150 in 1 BOTTLETABLET, FILM COATED15010
11673-571-49up and up allergy relief1 in 1 CARTONTABLET, FILM COATED110
11673-571-49up and up allergy relief40 in 1 BOTTLETABLET, FILM COATED4010
11673-571-75up and up allergy relief90 in 1 BOTTLETABLET, FILM COATED9010
11673-571-75up and up allergy relief1 in 1 CARTONTABLET, FILM COATED110
11673-571-76up and up allergy relief60 in 1 BOTTLETABLET, FILM COATED6010
11673-571-76up and up allergy relief2 in 1 CARTONTABLET, FILM COATED210
11673-571-87up and up allergy relief1 in 1 CARTONTABLET, FILM COATED110
11673-571-87up and up allergy relief300 in 1 BOTTLETABLET, FILM COATED30010
11673-571-95up and up allergy relief1 in 1 CARTONTABLET, FILM COATED110
11673-571-95up and up allergy relief45 in 1 BOTTLETABLET, FILM COATED4510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11673-571-22EA - Each11673-5716aab1ce5-1e7b-4721-bbd0-9d70b7eb95fa12015-05-05
11673-571-39EA - Each11673-57185bfe214-f5b4-43d7-aa49-b3b82db4ad4c12012-07-24
11673-571-95EA - Each11673-571937f1adf-d94e-4463-8205-4cc0c77419fb12013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUUP AND UP ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [TARGET CORPORATION]4
FEXOFENADINEACTIVE MOIETYE6582LOH6VUP AND UP ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [TARGET CORPORATION]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UUP AND UP ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [TARGET CORPORATION]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48UP AND UP ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [TARGET CORPORATION]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675UP AND UP ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [TARGET CORPORATION]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTUP AND UP ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [TARGET CORPORATION]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357UP AND UP ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [TARGET CORPORATION]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOUP AND UP ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [TARGET CORPORATION]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XUP AND UP ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [TARGET CORPORATION]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30UP AND UP ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [TARGET CORPORATION]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AUP AND UP ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [TARGET CORPORATION]4
POVIDONESINACTIVE INGREDIENTFZ989GH94EUP AND UP ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [TARGET CORPORATION]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4UP AND UP ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [TARGET CORPORATION]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPUP AND UP ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [TARGET CORPORATION]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-571UP AND UP ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [TARGET CORPORATION]10Legacy NDC, 19 package rows20220526_be80a7d9-e90b-460a-b72c-0ac60a75804b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNbe80a7d9-e90b-460a-b72c-0ac60a75804b10
997420fexofenadine hydrochloride 180 MG Oral TabletSCDbe80a7d9-e90b-460a-b72c-0ac60a75804b10
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYbe80a7d9-e90b-460a-b72c-0ac60a75804b10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11673-571-01116730571011 BOTTLE in 1 CARTON (11673-571-01) > 70 TABLET, FILM COATED in 1 BOTTLE1 bottle2015-03-170000-00-00NoNoCurrent
11673-571-221167305712215 BLISTER PACK in 1 CARTON (11673-571-22) > 1 TABLET, FILM COATED in 1 BLISTER PACK15 blister pack2011-04-260000-00-00NoNoCurrent
11673-571-331167305713360 in 1 BOTTLEHistorical
11673-571-39116730571391 BOTTLE in 1 CARTON (11673-571-39) > 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2011-04-130000-00-00NoNoCurrent
11673-571-47116730571471 BOTTLE in 1 CARTON (11673-571-47) > 150 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-01-300000-00-00NoNoCurrent
11673-571-49116730571491 BOTTLE in 1 CARTON (11673-571-49) > 40 TABLET, FILM COATED in 1 BOTTLE1 bottle2015-02-050000-00-00NoNoCurrent
11673-571-751167305717590 in 1 BOTTLEHistorical
11673-571-76116730571762 BOTTLE in 1 CARTON (11673-571-76) > 60 TABLET, FILM COATED in 1 BOTTLE (11673-571-33) 2 bottle2015-03-160000-00-00NoNoCurrent
11673-571-87116730571871 in 1 CARTONHistorical
11673-571-95116730571951 in 1 CARTONHistorical