Azelastine Hydrochloride

Product NDC: 51525-0294
11-digit product format: 515250294
Labeler code: 51525
Product ID: 51525-0294_cfc4a967-4b48-4fc6-b0b7-6557945fe3f3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Azelastine Hydrochloride
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: Wallace Pharmaceuticals Inc.
Application: NDA020114
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2010-07-01
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: 2022-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51525-0294-3	2020-07-22	C162847	48780-1	ab0e2407-34d6-f274-e053-dbdaa90a6471	4b114460-7a1c-11df-8b19-0002a5d5c51b

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51525-0294-3	ML - Milliliter	51525-0294	65cda3ff-cb8d-4780-a846-35ba12b46e71	1	2012-07-24

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0L591QR10I	AZELASTINE HYDROCHLORIDE	79307-93-0	AZELASTINE HYDROCHLORIDE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
51525-0294-3	51525029403	1 BOTTLE, SPRAY in 1 BOX (51525-0294-3) > 200 SPRAY, METERED in 1 BOTTLE, SPRAY	2010-07-01	0000-00-00	No	No	Current