Allergy Relief

Product NDC
80539-801
11-digit product format
805390801
Labeler code
80539
Product ID
80539-801_85a61c72-ee48-48e2-93c7-3e341f7cbad1
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCl
Dosage form
TABLET
Route
ORAL
Labeler
Allwell Health Inc
Application
ANDA211075
Marketing category
ANDA
Marketing start
2021-01-29
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80539-801-30805390801301 BOTTLE, PLASTIC in 1 BOX (80539-801-30) > 30 TABLET in 1 BOTTLE, PLASTIC2021-01-290000-00-00NoNoCurrent