AZELASTINE HYDROCHLORIDE

Product NDC
59651-215
11-digit product format
596510215
Labeler code
59651
Product ID
59651-215_35fa9463-da73-4fe5-9725-104546488e14
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AZELASTINE HYDROCHLORIDE
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Aurobindo Pharma Limited
Application
ANDA212775
Marketing category
ANDA
Marketing start
2020-11-12
Marketing end
2024-12-31
Substance
AZELASTINE HYDROCHLORIDE
Active strength
206 ug/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
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
59651-215-30ML - Milliliter59651-215283ca54e-d721-479f-9a65-65a411eeee0512021-05-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59651-215-30596510215301 BOTTLE, SPRAY in 1 CARTON (59651-215-30) > 200 SPRAY, METERED in 1 BOTTLE, SPRAY2020-11-120000-00-00NoNoCurrent