FDA.reportPublic FDA data

Fexofenadine Hydrochloride

Product NDC
62207-623
11-digit product format
622070623
Labeler code
62207
Product ID
62207-623_1d43d4d6-9021-eac7-e063-6294a90ad21a
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Granules India Limited
Application
ANDA211075
Marketing category
ANDA
Marketing start
2024-01-02
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 Hydrochloride
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
62207-623-41Fexofenadine Hydrochloride24 in 1 CONTAINERTABLET241
62207-623-45Fexofenadine Hydrochloride225 in 1 CONTAINERTABLET2251
62207-623-57Fexofenadine Hydrochloride90 in 1 CONTAINERTABLET901
62207-623-71Fexofenadine Hydrochloride7 in 1 CARTONTABLET71
62207-623-71Fexofenadine Hydrochloride10 in 1 BLISTER PACKTABLET101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62207-623FEXOFENADINE HYDROCHLORIDE TABLET [GRANULES INDIA LIMITED]1Current NDC, 5 package rows20240810_1d46555d-827b-b154-e063-6294a90ad3d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN1d46555d-827b-b154-e063-6294a90ad3d51
997420fexofenadine hydrochloride 180 MG Oral TabletSCD1d46555d-827b-b154-e063-6294a90ad3d51
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY1d46555d-827b-b154-e063-6294a90ad3d51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62207-623-416220706234124 TABLET in 1 CONTAINER (62207-623-41) 24 tablet2024-01-02NoNoHistorical
62207-623-4562207062345225 TABLET in 1 CONTAINER (62207-623-45) 225 tablet2024-01-02NoNoHistorical
62207-623-576220706235790 TABLET in 1 CONTAINER (62207-623-57) 90 tablet2024-01-02NoNoHistorical
62207-623-71622070623717 BLISTER PACK in 1 CARTON (62207-623-71) / 10 TABLET in 1 BLISTER PACK7 blister pack2024-01-02NoNoHistorical