FDA.reportPublic FDA data

allergy relief

Product NDC
79481-0847
11-digit product format
794810847
Labeler code
79481
Product ID
79481-0847_dfa09879-a814-421c-8ea8-09193bc1c09d
Type
HUMAN OTC DRUG
Nonproprietary name
fexofenadine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Meijer, Inc.
Application
ANDA212971
Marketing category
ANDA
Marketing start
2021-10-06
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
allergy relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEXOFENADINE HYDROCHLORIDE180 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S068B75ZU
Rxcui997420

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
79481-0847-0allergy relief15 in 1 CARTONTABLET, FILM COATED154
79481-0847-0allergy relief1 in 1 BLISTER PACKTABLET, FILM COATED14
79481-0847-1allergy relief30 in 1 BOTTLETABLET, FILM COATED304
79481-0847-1allergy relief1 in 1 CARTONTABLET, FILM COATED14
79481-0847-2allergy relief45 in 1 BOTTLETABLET, FILM COATED454
79481-0847-2allergy relief1 in 1 CARTONTABLET, FILM COATED14
79481-0847-3allergy relief1 in 1 CARTONTABLET, FILM COATED14
79481-0847-3allergy relief40 in 1 BOTTLETABLET, FILM COATED404
79481-0847-4allergy relief1 in 1 CARTONTABLET, FILM COATED14
79481-0847-4allergy relief90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-0847ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [MEIJER, INC.]4Current NDC, Legacy NDC, 10 package rows20240814_deecbf76-be1d-4b27-85c6-17cfb7e7d1a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNdeecbf76-be1d-4b27-85c6-17cfb7e7d1a14
997420fexofenadine hydrochloride 180 MG Oral TabletSCDdeecbf76-be1d-4b27-85c6-17cfb7e7d1a14
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYdeecbf76-be1d-4b27-85c6-17cfb7e7d1a14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79481-0847-07948108470015 BLISTER PACK in 1 CARTON (79481-0847-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK15 blister pack2021-10-180000-00-00NoNoCurrent
79481-0847-1794810847011 BOTTLE in 1 CARTON (79481-0847-1) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-10-060000-00-00NoNoCurrent
79481-0847-2794810847021 BOTTLE in 1 CARTON (79481-0847-2) / 45 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-10-180000-00-00NoNoCurrent
79481-0847-3794810847031 BOTTLE in 1 CARTON (79481-0847-3) / 40 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-07-25NoNoCurrent
79481-0847-4794810847041 BOTTLE in 1 CARTON (79481-0847-4) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-06-14NoNoCurrent