azelastine hydrochloride

Generic: azelastine hydrochloride

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azelastine hydrochloride
Generic Name azelastine hydrochloride
Labeler preferred pharmaceuticals inc.
Dosage Form SPRAY, METERED
Routes
NASAL
Active Ingredients

azelastine hydrochloride 137 ug/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8514
Product ID 68788-8514_1d9f784d-ffab-4ab2-8745-141d96ae8663
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212289
Listing Expiration 2026-12-31
Marketing Start 2023-09-01

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 687888514
Hyphenated Format 68788-8514

Supplemental Identifiers

RxCUI
1797867
UNII
0L591QR10I

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 (68788-8514-2) / 200 SPRAY, METERED in 1 BOTTLE, SPRAY
source: ndc

Packages (1)

68788-8514-2 1 BOTTLE, SPRAY in 1 CARTON (68788-8514-2) / 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": "1d9f784d-ffab-4ab2-8745-141d96ae8663", "openfda": {"unii": ["0L591QR10I"], "rxcui": ["1797867"], "spl_set_id": ["37c40f8d-269c-4df8-8ac7-cbe78f4ca5c4"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, SPRAY in 1 CARTON (68788-8514-2)  / 200 SPRAY, METERED in 1 BOTTLE, SPRAY", "package_ndc": "68788-8514-2", "marketing_start_date": "20230901"}], "brand_name": "AZELASTINE HYDROCHLORIDE", "product_id": "68788-8514_1d9f784d-ffab-4ab2-8745-141d96ae8663", "dosage_form": "SPRAY, METERED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68788-8514", "generic_name": "AZELASTINE HYDROCHLORIDE", "labeler_name": "Preferred Pharmaceuticals Inc.", "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": "20230901", "listing_expiration_date": "20261231"}