FDA.reportPublic FDA data

fexofenadine hcl

Product NDC
71335-2165
11-digit product format
713352165
Labeler code
71335
Product ID
71335-2165_04a27808-de0a-4100-9aff-3168e4fd231e
Type
HUMAN OTC DRUG
Nonproprietary name
fexofenadine hcl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204507
Marketing category
ANDA
Marketing start
2021-08-26
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
2026-12-31
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2015-09-16
A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2015-09-16
A204507-004FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2015-09-16
A204507-005FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2015-09-16

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
fexofenadine hclFEXOFENADINE HCLBryant Ranch Prepackc23ad304-a5de-454e-a135-4eb143af23812025-10-22WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions) Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Additional Listing Data#

Finished product
Yes
Brand name base
fexofenadine hcl
Listing expiration
2026-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2165-1fexofenadine hcl30 in 1 BOTTLETABLET, FILM COATED30104
71335-2165-2fexofenadine hcl10 in 1 BOTTLETABLET, FILM COATED10104
71335-2165-3fexofenadine hcl60 in 1 BOTTLETABLET, FILM COATED60104
71335-2165-4fexofenadine hcl90 in 1 BOTTLETABLET, FILM COATED90104
71335-2165-5fexofenadine hcl14 in 1 BOTTLETABLET, FILM COATED14104
71335-2165-6fexofenadine hcl20 in 1 BOTTLETABLET, FILM COATED20104
71335-2165-7fexofenadine hcl12 in 1 BOTTLETABLET, FILM COATED12104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2165FEXOFENADINE HCL TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 7 package rows20240925_c23ad304-a5de-454e-a135-4eb143af2381.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997501fexofenadine HCl 60 MG Oral TabletPSNc23ad304-a5de-454e-a135-4eb143af2381104
997501fexofenadine hydrochloride 60 MG Oral TabletSCDc23ad304-a5de-454e-a135-4eb143af2381104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2165-17133521650130 TABLET, FILM COATED in 1 BOTTLE (71335-2165-1) 2024-09-060000-00-00NoNoCurrent
71335-2165-27133521650210 TABLET, FILM COATED in 1 BOTTLE (71335-2165-2) 2022-08-250000-00-00NoNoCurrent
71335-2165-37133521650360 TABLET, FILM COATED in 1 BOTTLE (71335-2165-3) 2024-09-060000-00-00NoNoCurrent
71335-2165-47133521650490 TABLET, FILM COATED in 1 BOTTLE (71335-2165-4) 2024-09-060000-00-00NoNoCurrent
71335-2165-57133521650514 TABLET, FILM COATED in 1 BOTTLE (71335-2165-5) 2024-09-060000-00-00NoNoCurrent
71335-2165-67133521650620 TABLET, FILM COATED in 1 BOTTLE (71335-2165-6) 2024-09-060000-00-00NoNoCurrent
71335-2165-77133521650712 TABLET, FILM COATED in 1 BOTTLE (71335-2165-7) 2022-11-08NoNoCurrent