Fexofenadine hydrochloride

Product NDC
68071-2504
11-digit product format
680712504
Labeler code
68071
Product ID
68071-2504_c9b5cd8c-668d-b391-e053-2a95a90a7894
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA076502
Marketing category
ANDA
Marketing start
2011-01-03
Marketing end
0000-00-00
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
60 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
2S068B75ZUFEXOFENADINE HYDROCHLORIDE153439-40-8FEXOFENADINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2504-16807125040110 TABLET in 1 BOTTLE (68071-2504-1) 10 tablet2021-08-160000-00-00NoNoCurrent
68071-2504-96807125040990 TABLET in 1 BOTTLE (68071-2504-9) 90 tablet2021-08-160000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Fexofenadine HCl Tablets USPNuCare Pharmaceuticals,Inc.2021-08-16HUMAN OTC DRUG LABEL1