Fexofenadine HCL

Product NDC
50090-6965
11-digit product format
500906965
Labeler code
50090
Product ID
50090-6965_72dc2e57-df1a-4d62-a8a2-cde96890bc2c
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCL
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204097
Marketing category
ANDA
Marketing start
2019-02-18
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

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6965-0500906965001 BOTTLE in 1 CARTON (50090-6965-0) / 30 TABLET in 1 BOTTLE1 bottle2023-12-20NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Fexofenadine Hydrochloride Tablets USP, 180 mgA-S Medication Solutions2023-12-27Human OTC Drug Label1