azelastine hydrochloride

Generic: azelastine hydrochloride

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azelastine hydrochloride
Generic Name azelastine hydrochloride
Labeler sun pharmaceutical industries, inc.
Dosage Form SPRAY, METERED
Routes
NASAL
Active Ingredients

azelastine hydrochloride 137 ug/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-779
Product ID 47335-779_09652cb1-7315-4188-9f36-4e2b50fb764d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090423
Listing Expiration 2026-12-31
Marketing Start 2012-05-24

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 47335779
Hyphenated Format 47335-779

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 ANDA090423 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 137 ug/1
source: ndc
Packaging
  • 1 BOTTLE, SPRAY in 1 BOX (47335-779-91) / 200 SPRAY, METERED in 1 BOTTLE, SPRAY
source: ndc

Packages (1)

47335-779-91 1 BOTTLE, SPRAY in 1 BOX (47335-779-91) / 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": "09652cb1-7315-4188-9f36-4e2b50fb764d", "openfda": {"unii": ["0L591QR10I"], "rxcui": ["1797867"], "spl_set_id": ["305c6dc8-8247-473d-9975-b02903af6d53"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, SPRAY in 1 BOX (47335-779-91)  / 200 SPRAY, METERED in 1 BOTTLE, SPRAY", "package_ndc": "47335-779-91", "marketing_start_date": "20120524"}], "brand_name": "Azelastine Hydrochloride", "product_id": "47335-779_09652cb1-7315-4188-9f36-4e2b50fb764d", "dosage_form": "SPRAY, METERED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "47335-779", "generic_name": "Azelastine Hydrochloride", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azelastine Hydrochloride", "active_ingredients": [{"name": "AZELASTINE HYDROCHLORIDE", "strength": "137 ug/1"}], "application_number": "ANDA090423", "marketing_category": "ANDA", "marketing_start_date": "20120524", "listing_expiration_date": "20261231"}