FDA.reportPublic FDA data

fexofenadine hcl

Product NDC
71610-893
11-digit product format
716100893
Labeler code
71610
Product ID
71610-893_31e71ef2-159c-8273-e063-6294a90aaa08
Type
HUMAN OTC DRUG
Nonproprietary name
fexofenadine hcl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA204507
Marketing category
ANDA
Marketing start
2024-08-20
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
71610-893-53fexofenadine hcl60 in 1 BOTTLETABLET, FILM COATED601
71610-893-60fexofenadine hcl90 in 1 BOTTLETABLET, FILM COATED901
71610-893-70fexofenadine hcl120 in 1 BOTTLETABLET, FILM COATED1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-893-53EA - Each71610-89380d44d12-4afa-40f2-9f4c-6d12e2e3cfc312025-06-13
71610-893-60EA - Each71610-893bcf6dfe0-21f8-4651-abc2-9e5ec9d6f97712025-06-13
71610-893-70EA - Each71610-8934d8b0f57-e6ee-4524-a41d-984de9cb0fd412025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-893FEXOFENADINE HCL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]1Current NDC, 3 package rows20250406_31e71ee7-c4b5-6c1c-e063-6294a90a1513.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN31e71ee7-c4b5-6c1c-e063-6294a90a15131
997420fexofenadine hydrochloride 180 MG Oral TabletSCD31e71ee7-c4b5-6c1c-e063-6294a90a15131
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY31e71ee7-c4b5-6c1c-e063-6294a90a15131

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71610-893-537161008935360 TABLET, FILM COATED in 1 BOTTLE (71610-893-53) 2025-04-02NoNoCurrent
71610-893-607161008936090 TABLET, FILM COATED in 1 BOTTLE (71610-893-60) 2025-04-02NoNoCurrent
71610-893-7071610089370120 TABLET, FILM COATED in 1 BOTTLE (71610-893-70) 2025-04-02NoNoCurrent