FEXOFENADINE HCl

Product NDC
70677-1239
11-digit product format
706771239
Labeler code
70677
Product ID
70677-1239_498a79fc-c2a8-c5ea-e063-6294a90ab355
Type
HUMAN OTC DRUG
Nonproprietary name
FEXOFENADINE HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Strategic Sourcing Services, LLC
Application
ANDA210137
Marketing category
ANDA
Marketing start
2024-02-22
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
FEXOFENADINE HCl
Listing expiration
2027-12-31

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
70677-1239-1FEXOFENADINE HCl100 in 1 BOTTLETABLET, FILM COATED1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1239-1EA - Each70677-1239a40a68d0-3e4d-4867-a486-e1b885df182912024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1239FEXOFENADINE HCL TABLET, FILM COATED [STRATEGIC SOURCING SERVICES, LLC]3Current NDC, 1 package rows20250101_7a49f700-5892-404b-b81a-4a92c1928806.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN7a49f700-5892-404b-b81a-4a92c19288064
997420fexofenadine hydrochloride 180 MG Oral TabletSCD7a49f700-5892-404b-b81a-4a92c19288064
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY7a49f700-5892-404b-b81a-4a92c19288064

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70677-1239-170677123901100 TABLET, FILM COATED in 1 BOTTLE (70677-1239-1) 2024-02-22NoNoHistorical