Fexofenadine Hydrochloride

Product NDC
0904-6979
11-digit product format
009046979
Labeler code
0904
Product ID
0904-6979_5fdb4f82-4381-4d86-adba-ba4a798ab605
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA076447
Marketing category
ANDA
Marketing start
2011-08-08
Marketing end
0000-00-00
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
60 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6979-40EA - Each0904-6979c21b193e-7d05-41a3-a9fa-5ac0ddac9ba712019-11-12
0904-6979-60EA - Each0904-6979316d8cec-64ee-44b2-9bf6-4bbd589a3b7512019-11-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6979-4000904697940500 TABLET, FILM COATED in 1 BOTTLE (0904-6979-40) 2011-08-080000-00-00NoNoCurrent
0904-6979-60009046979601 BOTTLE in 1 CARTON (0904-6979-60) > 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-10-170000-00-00NoNoCurrent