Azelastine Hydrochloride

Product NDC
0054-0293
11-digit product format
000540293
Labeler code
0054
Product ID
0054-0293_420d7fc2-1aed-4a14-a6ce-db173115f1f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azelastine Hydrochloride
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
West-Ward Pharmaceuticals Corp.
Application
ANDA091444
Marketing category
ANDA
Marketing start
2014-10-27
Marketing end
0000-00-00
Substance
AZELASTINE HYDROCHLORIDE
Active strength
137 ug/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0293-99ML - Milliliter0054-0293950f6ed9-0885-4e00-aa00-516945791fc712014-11-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-0293-99000540293991 BOTTLE in 1 CARTON (0054-0293-99) > 200 SPRAY, METERED in 1 BOTTLE1 bottle2014-10-270000-00-00NoNoCurrent