FDA.reportPublic FDA data

Fexofenadine HCL

Product NDC
0363-9760
11-digit product format
003639760
Labeler code
0363
Product ID
0363-9760_4653e72d-0ac1-5261-e063-6394a90a698a
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCL
Dosage form
TABLET
Route
ORAL
Labeler
Walgreens
Application
ANDA211075
Marketing category
ANDA
Marketing start
2024-02-28
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 HCL
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
0363-9760-03Fexofenadine HCL30 in 1 BOTTLETABLET305
0363-9760-07Fexofenadine HCL15 in 1 BLISTER PACKTABLET155
0363-9760-14Fexofenadine HCL5 in 1 BLISTER PACKTABLET55
0363-9760-18Fexofenadine HCL180 in 1 BOTTLETABLET1805
0363-9760-34Fexofenadine HCL70 in 1 BOTTLETABLET705

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9760FEXOFENADINE HCL TABLET [WALGREENS]4Current NDC, 5 package rows20241218_fd775af1-782e-bb4f-e053-6294a90aaa5d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNfd775af1-782e-bb4f-e053-6294a90aaa5d5
997420fexofenadine hydrochloride 180 MG Oral TabletSCDfd775af1-782e-bb4f-e053-6294a90aaa5d5
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYfd775af1-782e-bb4f-e053-6294a90aaa5d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-9760-030036397600330 TABLET in 1 BOTTLE (0363-9760-03) 30 tablet2024-02-28NoNoHistorical
0363-9760-070036397600715 TABLET in 1 BLISTER PACK (0363-9760-07) 15 tablet2024-02-28NoNoHistorical
0363-9760-14003639760145 TABLET in 1 BLISTER PACK (0363-9760-14) 5 tablet2024-02-28NoNoHistorical
0363-9760-1800363976018180 TABLET in 1 BOTTLE (0363-9760-18) 180 tablet2024-02-28NoNoHistorical
0363-9760-340036397603470 TABLET in 1 BOTTLE (0363-9760-34) 70 tablet2024-02-28NoNoHistorical