AZELASTINE HYDROCHLORIDE

Product NDC
63629-2057
11-digit product format
636292057
Labeler code
63629
Product ID
63629-2057_dd929a1f-dc72-49bc-8f37-b01edaf74950
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AZELASTINE HYDROCHLORIDE
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Bryant Ranch Prepack
Application
ANDA090176
Marketing category
ANDA
Marketing start
2015-07-29
Marketing end
0000-00-00
Substance
AZELASTINE HYDROCHLORIDE
Active strength
137 ug/.137mL
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
63629-2057-1ML - Milliliter63629-2057ee23072a-9335-4424-aaf1-ea22bac2b57f12021-06-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-2057-1636292057011 BOTTLE, SPRAY in 1 CARTON (63629-2057-1) > 30 mL in 1 BOTTLE, SPRAY2021-02-100000-00-00NoNoCurrent