Wal-Fex

Product NDC
0363-0784
11-digit product format
003630784
Labeler code
0363
Product ID
0363-0784_7e7ffc3e-e6f3-18ec-ed27-f9268790597e
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Walgreens Company
Application
ANDA076502
Marketing category
ANDA
Marketing start
2011-04-13
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
Wal-Fex
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEXOFENADINE HYDROCHLORIDE180 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S068B75ZU
Rxcui997420, 1116528

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0784-07EA - Each0363-07844abb8391-85f7-4533-87b4-bb02fba2e64f12014-10-03
0363-0784-30EA - Each0363-07840b5d87a2-1f70-4070-909b-3dcf1d482dd512014-08-01
0363-0784-40EA - Each0363-0784f6f76809-284e-4bc2-8f9a-14e5a808bc4712022-06-06
0363-0784-43EA - Each0363-0784fafe2d1a-d34b-4245-865f-8c91c896d34812014-08-01
0363-0784-75EA - Each0363-0784755be56f-38e2-4d37-9c9d-cdb70885656e12014-10-03
0363-0784-90EA - Each0363-0784e565e771-000f-45f0-a40a-3d7737582d4612015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Fexofenadine HydrochlorideACTIVE INGREDIENT2S068B75ZUWAL-FEX (FEXOFENADINE HYDROCHLORIDE) TABLET [WALGREENS COMPANY]2
FEXOFENADINEACTIVE MOIETYE6582LOH6VWAL-FEX (FEXOFENADINE HYDROCHLORIDE) TABLET [WALGREENS COMPANY]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48WAL-FEX (FEXOFENADINE HYDROCHLORIDE) TABLET [WALGREENS COMPANY]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAWAL-FEX (FEXOFENADINE HYDROCHLORIDE) TABLET [WALGREENS COMPANY]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357WAL-FEX (FEXOFENADINE HYDROCHLORIDE) TABLET [WALGREENS COMPANY]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6WAL-FEX (FEXOFENADINE HYDROCHLORIDE) TABLET [WALGREENS COMPANY]2
magnesium stearateINACTIVE INGREDIENT70097M6I30WAL-FEX (FEXOFENADINE HYDROCHLORIDE) TABLET [WALGREENS COMPANY]2
mannitolINACTIVE INGREDIENT3OWL53L36AWAL-FEX (FEXOFENADINE HYDROCHLORIDE) TABLET [WALGREENS COMPANY]2
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQWAL-FEX (FEXOFENADINE HYDROCHLORIDE) TABLET [WALGREENS COMPANY]2
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MWAL-FEX (FEXOFENADINE HYDROCHLORIDE) TABLET [WALGREENS COMPANY]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4WAL-FEX (FEXOFENADINE HYDROCHLORIDE) TABLET [WALGREENS COMPANY]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJWAL-FEX (FEXOFENADINE HYDROCHLORIDE) TABLET [WALGREENS COMPANY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPWAL-FEX (FEXOFENADINE HYDROCHLORIDE) TABLET [WALGREENS COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0784WAL-FEX (FEXOFENADINE HYDROCHLORIDE) TABLET [WALGREENS COMPANY]6Current NDC, Legacy NDC20230628_95d420ea-6337-304f-54c3-0c75be1608e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN95d420ea-6337-304f-54c3-0c75be1608e26
1116528Wal-Fex Allergy 180 MG 24HR Oral TabletPSN95d420ea-6337-304f-54c3-0c75be1608e26
1116528fexofenadine hydrochloride 180 MG Oral Tablet [Wal-Fex]SBD95d420ea-6337-304f-54c3-0c75be1608e26
997420fexofenadine hydrochloride 180 MG Oral TabletSCD95d420ea-6337-304f-54c3-0c75be1608e26
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY95d420ea-6337-304f-54c3-0c75be1608e26
1116528Wal-Fex 24 HR 180 MG Oral TabletSY95d420ea-6337-304f-54c3-0c75be1608e26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0784-07003630784071 BLISTER PACK in 1 CARTON (0363-0784-07) / 5 TABLET in 1 BLISTER PACK1 blister pack2011-04-130000-00-00NoNoCurrent
0363-0784-15003630784151 BOTTLE in 1 CARTON (0363-0784-15) / 150 TABLET in 1 BOTTLE1 bottle2011-04-130000-00-00NoNoCurrent
0363-0784-1800363078418180 TABLET in 1 BOTTLE (0363-0784-18) 180 tablet2022-07-130000-00-00NoNoCurrent
0363-0784-29003630784293 BLISTER PACK in 1 CARTON (0363-0784-29) / 5 TABLET in 1 BLISTER PACK3 blister pack2011-04-130000-00-00NoNoCurrent
0363-0784-30003630784301 BOTTLE in 1 CARTON (0363-0784-30) / 30 TABLET in 1 BOTTLE1 bottle2011-04-130000-00-00NoNoCurrent
0363-0784-40003630784401 BOTTLE in 1 CARTON (0363-0784-40) / 40 TABLET in 1 BOTTLE1 bottle2011-04-130000-00-00NoNoCurrent
0363-0784-43003630784432 BOTTLE in 1 CARTON (0363-0784-43) / 30 TABLET in 1 BOTTLE2 bottle2011-04-130000-00-00NoNoCurrent
0363-0784-45003630784451 BOTTLE in 1 CARTON (0363-0784-45) / 45 TABLET in 1 BOTTLE1 bottle2011-04-130000-00-00NoNoCurrent
0363-0784-75003630784751 BOTTLE in 1 CARTON (0363-0784-75) / 70 TABLET in 1 BOTTLE1 bottle2011-04-130000-00-00NoNoCurrent
0363-0784-90003630784901 BOTTLE in 1 CARTON (0363-0784-90) / 90 TABLET in 1 BOTTLE1 bottle2011-04-130000-00-00NoNoCurrent