FDA.reportPublic FDA data

Fexofenadine Hydrochloride

Product NDC
58602-426
11-digit product format
586020426
Labeler code
58602
Product ID
58602-426_a75ff860-f7e0-4e19-846b-fbe33e0e1dfd
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine Hydrochloride Oral
Dosage form
SUSPENSION
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA213466
Marketing category
ANDA
Marketing start
2023-05-23
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
30 mg/5mL
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 HYDROCHLORIDE30 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S068B75ZU
Rxcui997491

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-426-20Fexofenadine Hydrochloride240 mL in 1 BOTTLESUSPENSION2402
58602-426-20Fexofenadine Hydrochloride1 in 1 CARTONSUSPENSION12
58602-426-24Fexofenadine Hydrochloride120 mL in 1 BOTTLESUSPENSION1202
58602-426-24Fexofenadine Hydrochloride1 in 1 CARTONSUSPENSION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-426FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HYDROCHLORIDE ORAL) SUSPENSION [AUROHEALTH LLC]2Current NDC, 4 package rows20230715_e8e35d7a-a86b-4d37-979b-f454978f070b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997491fexofenadine HCl 30 MG in 5 mL Oral SuspensionPSNe8e35d7a-a86b-4d37-979b-f454978f070b2
997491fexofenadine hydrochloride 6 MG/ML Oral SuspensionSCDe8e35d7a-a86b-4d37-979b-f454978f070b2
997491fexofenadine HCl 30 MG per 5 ML Oral SuspensionSYe8e35d7a-a86b-4d37-979b-f454978f070b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58602-426-20586020426201 BOTTLE in 1 CARTON (58602-426-20) / 240 mL in 1 BOTTLE1 bottle2023-05-23NoNoCurrent
58602-426-24586020426241 BOTTLE in 1 CARTON (58602-426-24) / 120 mL in 1 BOTTLE1 bottle2023-05-23NoNoCurrent