Azelastine Hydrochloride

Product NDC
51525-0234
11-digit product format
515250234
Labeler code
51525
Product ID
51525-0234_ca6890f6-752e-4e86-96e9-4a4b451cbb31
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azelastine hydrochloride
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Wallace Pharmaceuticals Inc.
Application
NDA022203
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2015-04-01
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51525-0234-32020-07-22C16284748780-1ab0e2407-3355-f274-e053-dbdaa90a6471232d5dda-e0f2-11e3-8b68-0800200c9a66

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51525-0234-3ML - Milliliter51525-02341c8f63ba-244d-45b4-af51-3b669e3a61c312015-05-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51525-0234-3515250234031 BOTTLE in 1 CARTON (51525-0234-3) > 200 SPRAY, METERED in 1 BOTTLE1 bottle2015-04-010000-00-00NoNoCurrent