FDA.reportPublic FDA data

Fexofenadine hydrochloride

Product NDC
13107-066
11-digit product format
131070066
Labeler code
13107
Product ID
13107-066_536dab2f-7586-4d45-b745-99c6cab47743
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurolife Pharma, LLC
Application
ANDA202039
Marketing category
ANDA
Marketing start
2015-08-26
Marketing end
0000-00-00
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
60 mg/1
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13107-066-052025-12-19C16284748780-19d75b9d0-fd9f-f424-e053-dadaa90a57cebc176016-ebab-4430-82ac-dde96b545194
13107-066-052020-01-31C16284748780-19d75b9d0-fd9f-f424-e053-dadaa90a57cebc176016-ebab-4430-82ac-dde96b545194

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13107-066-05EA - Each13107-066f90bcd92-7c7a-4425-9cf9-d59bec5aeb0512015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC]2
FEXOFENADINEACTIVE MOIETYE6582LOH6VFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC]2
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13107-066FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC]2Legacy NDC20150829_bc176016-ebab-4430-82ac-dde96b545194.zip