azelastine hydrochloride

Generic: azelastine

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azelastine hydrochloride
Generic Name azelastine
Labeler avkare
Dosage Form SPRAY, METERED
Routes
NASAL
Active Ingredients

azelastine hydrochloride 1 mg/mL

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-094
Product ID 42291-094_485b8c18-0782-37ea-e063-6394a90ad61e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204660
Listing Expiration 2027-12-31
Marketing Start 2021-03-03

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 42291094
Hyphenated Format 42291-094

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 (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 (42291-094-30) / 30 mL in 1 BOTTLE, SPRAY
source: ndc

Packages (1)

42291-094-30 1 BOTTLE, SPRAY in 1 CARTON (42291-094-30) / 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": "485b8c18-0782-37ea-e063-6394a90ad61e", "openfda": {"unii": ["0L591QR10I"], "rxcui": ["1797867"], "spl_set_id": ["bca75501-4140-4d77-e053-2a95a90a019f"], "manufacturer_name": ["AvKARE"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, SPRAY in 1 CARTON (42291-094-30)  / 30 mL in 1 BOTTLE, SPRAY", "package_ndc": "42291-094-30", "marketing_start_date": "20210303"}], "brand_name": "Azelastine Hydrochloride", "product_id": "42291-094_485b8c18-0782-37ea-e063-6394a90ad61e", "dosage_form": "SPRAY, METERED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "42291-094", "generic_name": "Azelastine", "labeler_name": "AvKARE", "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": "20210303", "listing_expiration_date": "20271231"}