FDA.reportPublic FDA data

FEXOFENADINE HYDROCHLORIDE

Product NDC
72090-010
11-digit product format
720900010
Labeler code
72090
Product ID
72090-010_2aa6e396-3103-48d1-bcd7-43b140549307
Type
HUMAN OTC DRUG
Nonproprietary name
FEXOFENADINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Pioneer Life Sciences, LLC
Application
ANDA210137
Marketing category
ANDA
Marketing start
2023-12-07
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
72090-010-01FEXOFENADINE HYDROCHLORIDE90 in 1 BOTTLETABLET903
72090-010-02FEXOFENADINE HYDROCHLORIDE100 in 1 BOTTLETABLET1003
72090-010-03FEXOFENADINE HYDROCHLORIDE50 in 1 BOTTLETABLET503
72090-010-04FEXOFENADINE HYDROCHLORIDE150 in 1 BOTTLETABLET1503
72090-010-99FEXOFENADINE HYDROCHLORIDE1000 in 1 BOTTLETABLET10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72090-010FEXOFENADINE HYDROCHLORIDE TABLET [PIONEER LIFE SCIENCES, LLC]2Current NDC, 1 package rows20241127_d3b6f04c-60d6-4ac3-9fb2-19eeb80f00a5.zip
72090-010FEXOFENADINE HYDROCHLORIDE TABLET [PIONEER LIFE SCIENCES, LLC]2Current NDC, 1 package rows20241127_d7fe71e4-aada-40f5-86a8-bf0d7eb9b851.zip
72090-010FEXOFENADINE HYDROCHLORIDE TABLET [PIONEER LIFE SCIENCES, LLC]2Current NDC, 3 package rows20241031_0a4f4178-bea5-4995-99dc-96980cccdc8a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN0a4f4178-bea5-4995-99dc-96980cccdc8a3
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNd3b6f04c-60d6-4ac3-9fb2-19eeb80f00a53
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNd7fe71e4-aada-40f5-86a8-bf0d7eb9b8513
997420fexofenadine hydrochloride 180 MG Oral TabletSCD0a4f4178-bea5-4995-99dc-96980cccdc8a3
997420fexofenadine hydrochloride 180 MG Oral TabletSCDd3b6f04c-60d6-4ac3-9fb2-19eeb80f00a53
997420fexofenadine hydrochloride 180 MG Oral TabletSCDd7fe71e4-aada-40f5-86a8-bf0d7eb9b8513
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY0a4f4178-bea5-4995-99dc-96980cccdc8a3
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYd3b6f04c-60d6-4ac3-9fb2-19eeb80f00a53
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYd7fe71e4-aada-40f5-86a8-bf0d7eb9b8513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72090-010-017209000100190 TABLET in 1 BOTTLE (72090-010-01) 90 tablet2023-12-07NoNoHistorical
72090-010-0272090001002100 TABLET in 1 BOTTLE (72090-010-02) 100 tablet2024-10-29NoNoHistorical
72090-010-037209000100350 TABLET in 1 BOTTLE (72090-010-03) 50 tablet2024-10-03NoNoHistorical
72090-010-0472090001004150 TABLET in 1 BOTTLE (72090-010-04) 150 tablet2024-10-03NoNoHistorical
72090-010-99720900010991000 TABLET in 1 BOTTLE (72090-010-99) 1000 tablet2023-08-11NoNoHistorical