azelastine hydrochloride

Generic: azelastine hydrochloride

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azelastine hydrochloride
Generic Name azelastine hydrochloride
Labeler northstar rx llc
Dosage Form SPRAY, METERED
Routes
NASAL
Active Ingredients

azelastine hydrochloride 137 ug/1

Manufacturer
NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 72603-611
Product ID 72603-611_cb0aca6d-ff9c-4239-8681-d212a6764ba9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212289
Listing Expiration 2026-12-31
Marketing Start 2025-07-01

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72603611
Hyphenated Format 72603-611

Supplemental Identifiers

RxCUI
1797867
UNII
0L591QR10I

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name azelastine hydrochloride (source: ndc)
Generic Name azelastine hydrochloride (source: ndc)
Application Number ANDA212289 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 137 ug/1
source: ndc
Packaging
  • 1 BOTTLE, SPRAY in 1 CARTON (72603-611-01) / 200 SPRAY, METERED in 1 BOTTLE, SPRAY
source: ndc

Packages (1)

72603-611-01 1 BOTTLE, SPRAY in 1 CARTON (72603-611-01) / 200 SPRAY, METERED in 1 BOTTLE, SPRAY

Ingredients (1)

azelastine hydrochloride (137 ug/1)

Linked Drug Pages (1)

AZELASTINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "cb0aca6d-ff9c-4239-8681-d212a6764ba9", "openfda": {"unii": ["0L591QR10I"], "rxcui": ["1797867"], "spl_set_id": ["cb0aca6d-ff9c-4239-8681-d212a6764ba9"], "manufacturer_name": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, SPRAY in 1 CARTON (72603-611-01)  / 200 SPRAY, METERED in 1 BOTTLE, SPRAY", "package_ndc": "72603-611-01", "marketing_start_date": "20250701"}], "brand_name": "AZELASTINE HYDROCHLORIDE", "product_id": "72603-611_cb0aca6d-ff9c-4239-8681-d212a6764ba9", "dosage_form": "SPRAY, METERED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "72603-611", "generic_name": "AZELASTINE HYDROCHLORIDE", "labeler_name": "NorthStar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AZELASTINE HYDROCHLORIDE", "active_ingredients": [{"name": "AZELASTINE HYDROCHLORIDE", "strength": "137 ug/1"}], "application_number": "ANDA212289", "marketing_category": "ANDA", "marketing_start_date": "20250701", "listing_expiration_date": "20261231"}