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 SOLUTION/ DROPS
Routes
INTRAOCULAR
Active Ingredients

azelastine hydrochloride .5 mg/mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-938
Product ID 47335-938_b2bdb49f-ef3d-467d-aa3b-d7ab72162f4b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078738
Listing Expiration 2026-12-31
Marketing Start 2010-05-31

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 47335938
Hyphenated Format 47335-938

Supplemental Identifiers

RxCUI
860805
UPC
0347335938906
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 ANDA078738 (source: ndc)
Routes
INTRAOCULAR
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 BOX (47335-938-90) / 6 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

47335-938-90 1 BOTTLE, PLASTIC in 1 BOX (47335-938-90) / 6 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

azelastine hydrochloride (.5 mg/mL)

Linked Drug Pages (1)

Azelastine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAOCULAR"], "spl_id": "b2bdb49f-ef3d-467d-aa3b-d7ab72162f4b", "openfda": {"upc": ["0347335938906"], "unii": ["0L591QR10I"], "rxcui": ["860805"], "spl_set_id": ["04e5eede-17ff-4765-af77-d46c139da703"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 BOX (47335-938-90)  / 6 mL in 1 BOTTLE, PLASTIC", "package_ndc": "47335-938-90", "marketing_start_date": "20100531"}], "brand_name": "Azelastine Hydrochloride", "product_id": "47335-938_b2bdb49f-ef3d-467d-aa3b-d7ab72162f4b", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "47335-938", "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": ".5 mg/mL"}], "application_number": "ANDA078738", "marketing_category": "ANDA", "marketing_start_date": "20100531", "listing_expiration_date": "20261231"}