FDA.reportPublic FDA data

CVS Fexofenadine Hydrochloride

Product NDC
51316-183
11-digit product format
513160183
Labeler code
51316
Product ID
51316-183_41c5bbff-5362-e7e2-e063-6294a90a5fc2
Type
HUMAN OTC DRUG
Nonproprietary name
FEXOFENADINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA210137
Marketing category
ANDA
Marketing start
2025-10-22
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CVS 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
51316-183-00CVS Fexofenadine Hydrochloride180 in 1 BOTTLETABLET1803

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN3d6c7b10-ed05-bbde-e063-6294a90ae92f3
997420fexofenadine hydrochloride 180 MG Oral TabletSCD3d6c7b10-ed05-bbde-e063-6294a90ae92f3
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY3d6c7b10-ed05-bbde-e063-6294a90ae92f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-183-0051316018300180 TABLET in 1 BOTTLE (51316-183-00) 180 tablet2025-10-22NoNoCurrent