picnic antihistamine

Product NDC
80159-112
11-digit product format
801590112
Labeler code
80159
Product ID
80159-112_6f8209d9-f5fa-4732-a007-f2290351a7a0
Type
HUMAN OTC DRUG
Nonproprietary name
fexofenadine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
30M One, Inc.
Application
ANDA212971
Marketing category
ANDA
Marketing start
2022-04-24
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80159-112-01801590112011 BOTTLE in 1 CARTON (80159-112-01) > 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-04-240000-00-00NoNoCurrent
80159-112-03801590112031 BOTTLE in 1 CAPSULE (80159-112-03) > 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-04-250000-00-00NoNoCurrent