FDA.reportPublic FDA data

Fexofenadine Hydrochloride

Product NDC
0904-7050
11-digit product format
009047050
Labeler code
0904
Product ID
0904-7050_33be2075-3e84-4738-af91-6f2f971cc0b4
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCl
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA204507
Marketing category
ANDA
Marketing start
2019-11-29
Marketing end
2026-10-28
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
180 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fexofenadine Hydrochloride

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
0904-7050-40Fexofenadine Hydrochloride500 in 1 BOTTLE, PLASTICTABLET5006
0904-7050-60Fexofenadine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7050-40EA - Each0904-7050117e3570-1242-43c4-bd5e-a74ba384b7ab12020-03-10
0904-7050-60EA - Each0904-705090fd9bed-eb80-4f56-b9fa-d27a4ddcba2c12020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7050FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET [MAJOR PHARMACEUTICALS]4Current NDC, Legacy NDC, 2 package rows20221211_c34cda59-8a63-48ab-a19d-c06a1878f5da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNc34cda59-8a63-48ab-a19d-c06a1878f5da6
997420fexofenadine hydrochloride 180 MG Oral TabletSCDc34cda59-8a63-48ab-a19d-c06a1878f5da6
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYc34cda59-8a63-48ab-a19d-c06a1878f5da6
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNf2b6c157-1af1-8d43-e053-2995a90aaf1a2
997420fexofenadine hydrochloride 180 MG Oral TabletSCDf2b6c157-1af1-8d43-e053-2995a90aaf1a2
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYf2b6c157-1af1-8d43-e053-2995a90aaf1a2
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN2a59f3cd-4c11-4fc4-ac77-c6a2af12ce9e1
997420fexofenadine hydrochloride 180 MG Oral TabletSCD2a59f3cd-4c11-4fc4-ac77-c6a2af12ce9e1
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY2a59f3cd-4c11-4fc4-ac77-c6a2af12ce9e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7050-4000904705040500 TABLET in 1 BOTTLE, PLASTIC (0904-7050-40) 500 tablet2019-11-292026-10-28NoNoCurrent
0904-7050-6000904705060100 TABLET in 1 BOTTLE, PLASTIC (0904-7050-60) 100 tablet2019-11-292026-10-28NoNoCurrent