Fexofenadine Hydrochloride

Product NDC
30142-091
11-digit product format
301420091
Labeler code
30142
Product ID
30142-091_31573c90-831d-5cae-0ff1-62ffa650de02
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine Hydrochloride 60 mg
Dosage form
TABLET
Route
ORAL
Labeler
Kroger Company
Application
ANDA076502
Marketing category
ANDA
Marketing start
2022-01-03
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
60 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 HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S068B75ZU
Rxcui997501

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
30142-091-12Fexofenadine Hydrochloride2 in 1 CARTONTABLET25
30142-091-12Fexofenadine Hydrochloride6 in 1 BLISTER PACKTABLET65

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-091FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HYDROCHLORIDE 60 MG) TABLET [KROGER COMPANY]4Current NDC, Legacy NDC, 2 package rows20241114_98768939-d3d2-b294-4a20-57eba65880ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997501fexofenadine HCl 60 MG Oral TabletPSN98768939-d3d2-b294-4a20-57eba65880ab5
997501fexofenadine hydrochloride 60 MG Oral TabletSCD98768939-d3d2-b294-4a20-57eba65880ab5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-091-12301420091122 BLISTER PACK in 1 CARTON (30142-091-12) / 6 TABLET in 1 BLISTER PACK2 blister pack2022-01-030000-00-00NoNoCurrent