azelastine hydrochloride

Generic: azelastine hydrochloride

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

azelastine hydrochloride .5 mg/mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 61314-308
Product ID 61314-308_8d1b371d-f84a-4054-9a54-7cde00000f81
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202305
Listing Expiration 2026-12-31
Marketing Start 2013-03-21

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 61314308
Hyphenated Format 61314-308

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 ANDA202305 (source: ndc)
Routes
INTRAOCULAR
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (61314-308-02) / 6 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

61314-308-02 1 BOTTLE, PLASTIC in 1 CARTON (61314-308-02) / 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": "8d1b371d-f84a-4054-9a54-7cde00000f81", "openfda": {"unii": ["0L591QR10I"], "rxcui": ["860805"], "spl_set_id": ["6945fb86-27fb-4bab-8908-98772c6269c5"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (61314-308-02)  / 6 mL in 1 BOTTLE, PLASTIC", "package_ndc": "61314-308-02", "marketing_start_date": "20130321"}], "brand_name": "Azelastine Hydrochloride", "product_id": "61314-308_8d1b371d-f84a-4054-9a54-7cde00000f81", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "61314-308", "generic_name": "azelastine hydrochloride", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azelastine Hydrochloride", "active_ingredients": [{"name": "AZELASTINE HYDROCHLORIDE", "strength": ".5 mg/mL"}], "application_number": "ANDA202305", "marketing_category": "ANDA", "marketing_start_date": "20130321", "listing_expiration_date": "20261231"}