FDA.reportPublic FDA data

FEXOFENADINE HYDROCHLORIDE

Product NDC
51316-800
11-digit product format
513160800
Labeler code
51316
Product ID
51316-800_e6bae65e-9f41-4976-bebd-c14e86da14cb
Type
HUMAN OTC DRUG
Nonproprietary name
FEXOFENADINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
CVS PHARMACY, INC
Application
ANDA091567
Marketing category
ANDA
Marketing start
2022-09-20
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
51316-800-08FEXOFENADINE HYDROCHLORIDE180 in 1 BOTTLETABLET1804
51316-800-08FEXOFENADINE HYDROCHLORIDE1 in 1 CARTONTABLET14
51316-800-15FEXOFENADINE HYDROCHLORIDE1 in 1 CARTONTABLET14
51316-800-15FEXOFENADINE HYDROCHLORIDE15 in 1 BLISTER PACKTABLET154
51316-800-30FEXOFENADINE HYDROCHLORIDE30 in 1 BOTTLETABLET304
51316-800-30FEXOFENADINE HYDROCHLORIDE1 in 1 CARTONTABLET14
51316-800-45FEXOFENADINE HYDROCHLORIDE45 in 1 BOTTLETABLET454
51316-800-45FEXOFENADINE HYDROCHLORIDE1 in 1 CARTONTABLET14
51316-800-70FEXOFENADINE HYDROCHLORIDE70 in 1 BOTTLETABLET704
51316-800-70FEXOFENADINE HYDROCHLORIDE1 in 1 CARTONTABLET14
51316-800-90FEXOFENADINE HYDROCHLORIDE90 in 1 BOTTLETABLET904
51316-800-90FEXOFENADINE HYDROCHLORIDE1 in 1 CARTONTABLET14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-800FEXOFENADINE HYDROCHLORIDE TABLET [CVS PHARMACY, INC]4Current NDC, 12 package rows20240530_7bc13851-291a-4582-8261-13c5022fbdd1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN7bc13851-291a-4582-8261-13c5022fbdd14
997420fexofenadine hydrochloride 180 MG Oral TabletSCD7bc13851-291a-4582-8261-13c5022fbdd14
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY7bc13851-291a-4582-8261-13c5022fbdd14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-800-08513160800081 BOTTLE in 1 CARTON (51316-800-08) / 180 TABLET in 1 BOTTLE1 bottle2022-09-20NoNoHistorical
51316-800-15513160800151 BLISTER PACK in 1 CARTON (51316-800-15) / 15 TABLET in 1 BLISTER PACK1 blister pack2022-09-20NoNoHistorical
51316-800-30513160800301 BOTTLE in 1 CARTON (51316-800-30) / 30 TABLET in 1 BOTTLE1 bottle2022-09-20NoNoHistorical
51316-800-45513160800451 BOTTLE in 1 CARTON (51316-800-45) / 45 TABLET in 1 BOTTLE1 bottle2022-09-20NoNoHistorical
51316-800-70513160800701 BOTTLE in 1 CARTON (51316-800-70) / 70 TABLET in 1 BOTTLE1 bottle2022-09-20NoNoHistorical
51316-800-90513160800901 BOTTLE in 1 CARTON (51316-800-90) / 90 TABLET in 1 BOTTLE1 bottle2022-09-20NoNoHistorical