Allergy Relief

Product NDC
0904-6978
11-digit product format
009046978
Labeler code
0904
Product ID
0904-6978_6804cfcf-9f92-4a48-84fc-ebfa7168101d
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCL
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA204097
Marketing category
ANDA
Marketing start
2019-09-23
Marketing end
2021-11-30
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
0904-6978-40EA - Each0904-697847238971-01d7-4e43-9631-844400b622ae12019-11-12
0904-6978-60EA - Each0904-6978fa7167f2-170c-4579-8baa-899fb18f5c5012019-11-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0904-6978-4000904697840500 TABLET, COATED in 1 BOTTLE, PLASTIC (0904-6978-40) 2019-09-232021-11-30NoNoCurrent
0904-6978-6000904697860100 TABLET, COATED in 1 BOTTLE, PLASTIC (0904-6978-60) 2019-09-232021-11-30NoNoCurrent