FDA.reportPublic FDA data

Fexofenadine Hydrochloride

Product NDC
21695-462
11-digit product format
216950462
Labeler code
21695
Product ID
21695-462_2db62c07-21be-4378-82fc-a1bd9dc6e3ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fexofenadine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA076502
Marketing category
ANDA
Marketing start
2009-12-09
Marketing end
0000-00-00
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
180 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-462-102019-09-24C16284748780-1934fe258-48d5-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use fexofenadine hydrochloride tablets safely and effectively. See full prescribing information for fexofenadine hydrochloride. Initial U.S. Approval: 1996
21695-462-302019-09-24C16284748780-1934fe258-48d5-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use fexofenadine hydrochloride tablets safely and effectively. See full prescribing information for fexofenadine hydrochloride. Initial U.S. Approval: 1996
21695-462-602019-09-24C16284748780-1934fe258-48d5-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use fexofenadine hydrochloride tablets safely and effectively. See full prescribing information for fexofenadine hydrochloride. Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-462-10Fexofenadine Hydrochloride10 in 1 BOTTLETABLET102
21695-462-30Fexofenadine Hydrochloride30 in 1 BOTTLETABLET302
21695-462-60Fexofenadine Hydrochloride60 in 1 BOTTLETABLET602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-462-10EA - Each21695-462e2480304-173b-4e7c-821b-0592ed6992a412013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUFEXOFENADINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]2
FEXOFENADINEACTIVE MOIETYE6582LOH6VFEXOFENADINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FEXOFENADINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFEXOFENADINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357FEXOFENADINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6FEXOFENADINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FEXOFENADINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AFEXOFENADINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQFEXOFENADINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FEXOFENADINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFEXOFENADINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFEXOFENADINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-462FEXOFENADINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]2Legacy NDC, 3 package rows20110201_e5a207e4-472b-4bf9-8cd3-a018ef3a82bb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNe5a207e4-472b-4bf9-8cd3-a018ef3a82bb2
997501fexofenadine HCl 60 MG Oral TabletPSNe5a207e4-472b-4bf9-8cd3-a018ef3a82bb2
997420fexofenadine hydrochloride 180 MG Oral TabletSCDe5a207e4-472b-4bf9-8cd3-a018ef3a82bb2
997501fexofenadine hydrochloride 60 MG Oral TabletSCDe5a207e4-472b-4bf9-8cd3-a018ef3a82bb2
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYe5a207e4-472b-4bf9-8cd3-a018ef3a82bb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-462-102169504621010 in 1 BOTTLEHistorical
21695-462-302169504623030 in 1 BOTTLEHistorical
21695-462-602169504626060 in 1 BOTTLEHistorical