azelastine hydrochloride

Generic: azelastine hydrochloride

Labeler: fosun pharma usa inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azelastine hydrochloride
Generic Name azelastine hydrochloride
Labeler fosun pharma usa inc
Dosage Form SOLUTION/ DROPS
Routes
INTRAOCULAR
Active Ingredients

azelastine hydrochloride .5 mg/mL

Manufacturer
Fosun Pharma USA Inc

Identifiers & Regulatory

Product NDC 72266-141
Product ID 72266-141_3282899a-e3ac-971f-e063-6394a90ae53d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210092
Listing Expiration 2026-12-31
Marketing Start 2020-09-08

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 72266141
Hyphenated Format 72266-141

Supplemental Identifiers

RxCUI
860805
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 ANDA210092 (source: ndc)
Routes
INTRAOCULAR
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (72266-141-01) / 6 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

72266-141-01 1 BOTTLE, PLASTIC in 1 CARTON (72266-141-01) / 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": "3282899a-e3ac-971f-e063-6394a90ae53d", "openfda": {"unii": ["0L591QR10I"], "rxcui": ["860805"], "spl_set_id": ["8ae2aec7-329b-41bf-89d5-f189afb782ee"], "manufacturer_name": ["Fosun Pharma USA Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (72266-141-01)  / 6 mL in 1 BOTTLE, PLASTIC", "package_ndc": "72266-141-01", "marketing_start_date": "20200908"}], "brand_name": "Azelastine Hydrochloride", "product_id": "72266-141_3282899a-e3ac-971f-e063-6394a90ae53d", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "72266-141", "generic_name": "Azelastine Hydrochloride", "labeler_name": "Fosun Pharma USA Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azelastine Hydrochloride", "active_ingredients": [{"name": "AZELASTINE HYDROCHLORIDE", "strength": ".5 mg/mL"}], "application_number": "ANDA210092", "marketing_category": "ANDA", "marketing_start_date": "20200908", "listing_expiration_date": "20261231"}