CVS Fexofenadine Hydrochloride

Product NDC
51316-183
11-digit product format
513160183
Labeler code
51316
Product ID
51316-183_41c5bbff-5362-e7e2-e063-6294a90a5fc2
Type
HUMAN OTC DRUG
Nonproprietary name
FEXOFENADINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA210137
Marketing category
ANDA
Marketing start
2025-10-22
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
51316-183-0051316018300180 TABLET in 1 BOTTLE (51316-183-00) 180 tablet2025-10-22NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
CVS Fexofenadine HydrochlorideCVS Pharmacy2025-10-22HUMAN OTC DRUG LABEL3