FDA.reportPublic FDA data

fexofenadine hcl

Product NDC
71399-8659
11-digit product format
713998659
Labeler code
71399
Product ID
71399-8659_48c50815-5149-7bba-e063-6294a90a714d
Type
HUMAN OTC DRUG
Nonproprietary name
fexofenadine hcl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AKRON PHARMA INC
Application
ANDA204507
Marketing category
ANDA
Marketing start
2014-12-26
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
fexofenadine hcl
Listing expiration
2027-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71399-8659-12023-02-28C16284748780-1f386c64a-27a1-0266-e053-dadaa90a7c1afe67f0f1-c6f1-424e-8226-19176de79945
71399-8659-12023-01-30C16284748780-1f386c64a-27a1-0266-e053-dadaa90a7c1afe67f0f1-c6f1-424e-8226-19176de79945

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-8659-1fexofenadine hcl100 in 1 BOTTLETABLET, FILM COATED1004
71399-8659-5fexofenadine hcl500 in 1 BOTTLETABLET, FILM COATED5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-8659-1EA - Each71399-8659ec65a1bd-e066-474c-9ba3-4bf7bf1467f612021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-8659FEXOFENADINE HCL TABLET, FILM COATED [AKRON PHARMA INC]3Current NDC, Legacy NDC, 2 package rows20240221_fe67f0f1-c6f1-424e-8226-19176de79945.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997501fexofenadine HCl 60 MG Oral TabletPSNfe67f0f1-c6f1-424e-8226-19176de799454
997501fexofenadine hydrochloride 60 MG Oral TabletSCDfe67f0f1-c6f1-424e-8226-19176de799454

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71399-8659-171399865901100 TABLET, FILM COATED in 1 BOTTLE (71399-8659-1) 2021-11-010000-00-00NoNoCurrent
71399-8659-571399865905500 TABLET, FILM COATED in 1 BOTTLE (71399-8659-5) 2024-02-02NoNoCurrent