Fexofenadine Hydrochloride

Product NDC
71205-739
11-digit product format
712050739
Labeler code
71205
Product ID
71205-739_4a9b4b7f-0441-44d3-86c7-2542ef4b119a
Type
HUMAN OTC DRUG
Nonproprietary name
fexofenadine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA212971
Marketing category
ANDA
Marketing start
2022-01-07
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
71205-739-30Fexofenadine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED301
71205-739-60Fexofenadine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED601
71205-739-90Fexofenadine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-739-60EA - Each71205-7390463b2a6-ddcf-4492-b2e1-eca728128b1012023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-739FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1Current NDC, Legacy NDC, 3 package rows20230106_4a9b4b7f-0441-44d3-86c7-2542ef4b119a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN4a9b4b7f-0441-44d3-86c7-2542ef4b119a1
997420fexofenadine hydrochloride 180 MG Oral TabletSCD4a9b4b7f-0441-44d3-86c7-2542ef4b119a1
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY4a9b4b7f-0441-44d3-86c7-2542ef4b119a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-739-307120507393030 TABLET, FILM COATED in 1 BOTTLE (71205-739-30) 2022-12-280000-00-00NoNoCurrent
71205-739-607120507396060 TABLET, FILM COATED in 1 BOTTLE (71205-739-60) 2022-12-280000-00-00NoNoCurrent
71205-739-907120507399090 TABLET, FILM COATED in 1 BOTTLE (71205-739-90) 2022-12-280000-00-00NoNoCurrent