Fexofenadine Hydrochloride

Product NDC
0378-0782
11-digit product format
003780782
Labeler code
0378
Product ID
0378-0782_f35905cb-7f58-41f1-a851-403032789d14
Type
HUMAN OTC DRUG
Nonproprietary name
fexofenadine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA077081
Marketing category
ANDA
Marketing start
2011-08-25
Marketing end
2022-02-28
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
180 mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0782-05EA - Each0378-07823fe6c6e2-d32d-4bd6-b729-b96836b92ba612012-07-24
0378-0782-93EA - Each0378-0782c464c35e-8ecf-4f93-9c1c-077c0c71e27612013-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-0782-0500378078205500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0782-05) 2011-08-250000-00-00NoNoCurrent
0378-0782-930037807829330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0782-93) 2011-08-252022-02-28NoNoCurrent