azelastine hydrochloride

Generic: azelastine

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

azelastine hydrochloride 1 mg/mL

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-676
Product ID 65162-676_0ead3061-d60d-4911-91cc-489d3b5fe573
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204660
Listing Expiration 2026-12-31
Marketing Start 2017-09-05

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 65162676
Hyphenated Format 65162-676

Supplemental Identifiers

RxCUI
1797867
UPC
0365162676846
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 (source: ndc)
Application Number ANDA204660 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, SPRAY in 1 CARTON (65162-676-84) / 30 mL in 1 BOTTLE, SPRAY
source: ndc

Packages (1)

65162-676-84 1 BOTTLE, SPRAY in 1 CARTON (65162-676-84) / 30 mL in 1 BOTTLE, SPRAY

Ingredients (1)

azelastine hydrochloride (1 mg/mL)

Linked Drug Pages (1)

Azelastine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "0ead3061-d60d-4911-91cc-489d3b5fe573", "openfda": {"upc": ["0365162676846"], "unii": ["0L591QR10I"], "rxcui": ["1797867"], "spl_set_id": ["7902605c-944a-4d7e-a7d4-eb4a71bcacdb"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, SPRAY in 1 CARTON (65162-676-84)  / 30 mL in 1 BOTTLE, SPRAY", "package_ndc": "65162-676-84", "marketing_start_date": "20170905"}], "brand_name": "Azelastine Hydrochloride", "product_id": "65162-676_0ead3061-d60d-4911-91cc-489d3b5fe573", "dosage_form": "SPRAY, METERED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "65162-676", "generic_name": "Azelastine", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azelastine Hydrochloride", "active_ingredients": [{"name": "AZELASTINE HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA204660", "marketing_category": "ANDA", "marketing_start_date": "20170905", "listing_expiration_date": "20261231"}