Fexofenadine hydrochloride

Product NDC
55910-111
11-digit product format
559100111
Labeler code
55910
Product ID
55910-111_70e933f5-e72a-663c-784c-2eb38e453301
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Dollar General
Application
ANDA076502
Marketing category
ANDA
Marketing start
2019-07-17
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
Fexofenadine hydrochloride
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-111-30Fexofenadine hydrochloride30 in 1 BOTTLETABLET307
55910-111-30Fexofenadine hydrochloride1 in 1 CARTONTABLET17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-111FEXOFENADINE HYDROCHLORIDE TABLET [DOLLAR GENERAL ]7Current NDC, Legacy NDC, 2 package rows20241114_1b2a14a1-a5cc-4f5e-8127-57e9d913f50a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN1b2a14a1-a5cc-4f5e-8127-57e9d913f50a7
997420fexofenadine hydrochloride 180 MG Oral TabletSCD1b2a14a1-a5cc-4f5e-8127-57e9d913f50a7
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY1b2a14a1-a5cc-4f5e-8127-57e9d913f50a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-111-30559100111301 BOTTLE in 1 CARTON (55910-111-30) / 30 TABLET in 1 BOTTLE1 bottle2019-07-170000-00-00NoNoCurrent