Azelastine Hydrochloride

Product NDC
17478-718
11-digit product format
174780718
Labeler code
17478
Product ID
17478-718_8e6eaf05-ddf4-43c2-bc8a-6af44ea7fe2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azelastine Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Akorn
Application
ANDA203660
Marketing category
ANDA
Marketing start
2016-11-08
Marketing end
0000-00-00
Substance
AZELASTINE HYDROCHLORIDE
Active strength
1 mg/mL
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-718-10ML - Milliliter17478-7184f157f7e-0aa2-43a6-a7f8-64a020799fc212017-03-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17478-718-10174780718106 mL in 1 BOTTLE, DROPPER (17478-718-10) 6 ml2016-11-080000-00-00NoNoCurrent