FDA.reportPublic FDA data

Fexofenadine HCL

Product NDC
11673-767
11-digit product format
116730767
Labeler code
11673
Product ID
11673-767_46534182-fd58-f797-e063-6294a90a5106
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCL
Dosage form
TABLET
Route
ORAL
Labeler
TARGET CORPORATION
Application
ANDA211075
Marketing category
ANDA
Marketing start
2024-03-01
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 HCL
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
11673-767-03Fexofenadine HCL30 in 1 BOTTLETABLET306
11673-767-07Fexofenadine HCL15 in 1 BLISTER PACKTABLET156
11673-767-15Fexofenadine HCL150 in 1 BOTTLETABLET1506
11673-767-34Fexofenadine HCL70 in 1 BOTTLETABLET706

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-767FEXOFENADINE HCL TABLET [TARGET CORPORATION]4Current NDC, 4 package rows20241222_fdb8451b-fba3-c7ca-e053-6294a90a05d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNfdb8451b-fba3-c7ca-e053-6294a90a05d76
997420fexofenadine hydrochloride 180 MG Oral TabletSCDfdb8451b-fba3-c7ca-e053-6294a90a05d76
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYfdb8451b-fba3-c7ca-e053-6294a90a05d76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11673-767-031167307670330 TABLET in 1 BOTTLE (11673-767-03) 30 tablet2024-03-01NoNoCurrent
11673-767-071167307670715 TABLET in 1 BLISTER PACK (11673-767-07) 15 tablet2024-03-01NoNoCurrent
11673-767-1511673076715150 TABLET in 1 BOTTLE (11673-767-15) 150 tablet2024-03-01NoNoCurrent
11673-767-341167307673470 TABLET in 1 BOTTLE (11673-767-34) 70 tablet2024-03-01NoNoCurrent