Fexofenadine Hydrochloride

Product NDC
70677-1009
11-digit product format
706771009
Labeler code
70677
Product ID
70677-1009_1982b8ab-b306-c1f8-0490-943207d2b606
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Strategic Sourcing Services, LLC
Application
ANDA076502
Marketing category
ANDA
Marketing start
2019-09-09
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
70677-1009-1706771009013 BLISTER PACK in 1 CARTON (70677-1009-1) / 5 TABLET in 1 BLISTER PACK3 blister pack2023-05-05NoNoHistorical
70677-1009-2706771009021 BOTTLE in 1 CARTON (70677-1009-2) / 30 TABLET in 1 BOTTLE1 bottle2023-05-05NoNoHistorical
70677-1009-3706771009031 BOTTLE in 1 CARTON (70677-1009-3) / 70 TABLET in 1 BOTTLE1 bottle2023-05-05NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Fexofenadine HCl Tablets USPStrategic Sourcing Services, LLC2023-04-21HUMAN OTC DRUG LABEL1