FEXOFENADINE HCl

Product NDC
68210-4148
11-digit product format
682104148
Labeler code
68210
Product ID
68210-4148_ee8f07cf-0d57-6d6b-e053-2a95a90a98a6
Type
HUMAN OTC DRUG
Nonproprietary name
FEXOFENADINE HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Spirit Pharmaceuticals LLC
Application
ANDA210137
Marketing category
ANDA
Marketing start
2021-04-28
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

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
68210-4148-4FEXOFENADINE HCl4 in 1 BLISTER PACKTABLET, FILM COATED45
68210-4148-4FEXOFENADINE HCl1 in 1 CARTONTABLET, FILM COATED15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4148FEXOFENADINE HCL TABLET, FILM COATED [SPIRIT PHARMACEUTICALS LLC]5Legacy NDC, 2 package rows20241215_f0ea471e-de9f-4048-a48c-cfe858774854.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNf0ea471e-de9f-4048-a48c-cfe8587748545
997420fexofenadine hydrochloride 180 MG Oral TabletSCDf0ea471e-de9f-4048-a48c-cfe8587748545
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYf0ea471e-de9f-4048-a48c-cfe8587748545

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68210-4148-4682104148041 BLISTER PACK in 1 CARTON (68210-4148-4) > 4 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2021-04-280000-00-00NoNoCurrent