FDA.reportPublic FDA data

Fexofenadine HCL

Product NDC
70010-183
11-digit product format
700100183
Labeler code
70010
Product ID
70010-183_451e21a2-6057-7a94-e063-6294a90a9f87
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCL
Dosage form
TABLET
Route
ORAL
Labeler
GRANULES PHARMACEUTICALS INC.
Application
ANDA211075
Marketing category
ANDA
Marketing start
2023-04-25
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

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2019-10-18
A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2019-10-18

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 HCLGRANULES PHARMACEUTICALS INC.fa30c8ce-ad9d-b6fe-e053-6294a90a24432025-12-04WarningsExact identifier

Warnings cross-check#

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

warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

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
70010-183-03Fexofenadine HCL30 in 1 BOTTLETABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-183FEXOFENADINE HCL TABLET [GRANULES PHARMACEUTICALS INC.]1Current NDC, 1 package rows20230428_fa30c8ce-ad9d-b6fe-e053-6294a90a2443.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNfa30c8ce-ad9d-b6fe-e053-6294a90a24432
997420fexofenadine hydrochloride 180 MG Oral TabletSCDfa30c8ce-ad9d-b6fe-e053-6294a90a24432
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYfa30c8ce-ad9d-b6fe-e053-6294a90a24432

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70010-183-037001001830330 TABLET in 1 BOTTLE (70010-183-03) 30 tablet2023-04-25NoNoCurrent