azelastine

Generic: azelastine

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azelastine
Generic Name azelastine
Labeler ascend laboratories, llc
Dosage Form SPRAY, METERED
Routes
NASAL
Active Ingredients

azelastine hydrochloride 137 ug/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-477
Product ID 67877-477_25fdc0b5-0653-4aed-b3a4-cfbfad9f12ae
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208156
Listing Expiration 2026-12-31
Marketing Start 2017-08-18

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 67877477
Hyphenated Format 67877-477

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 (source: ndc)
Generic Name azelastine (source: ndc)
Application Number ANDA208156 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 137 ug/1
source: ndc
Packaging
  • 1 SPRAY, METERED in 1 BOTTLE (67877-477-50)
source: ndc

Packages (1)

67877-477-50 1 SPRAY, METERED in 1 BOTTLE (67877-477-50)

Ingredients (1)

azelastine hydrochloride (137 ug/1)

Linked Drug Pages (1)

Azelastine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "25fdc0b5-0653-4aed-b3a4-cfbfad9f12ae", "openfda": {"unii": ["0L591QR10I"], "rxcui": ["1797867"], "spl_set_id": ["77b20c6b-f30f-42a9-a0ef-d5d0bd3feb56"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SPRAY, METERED in 1 BOTTLE (67877-477-50)", "package_ndc": "67877-477-50", "marketing_start_date": "20170818"}], "brand_name": "Azelastine", "product_id": "67877-477_25fdc0b5-0653-4aed-b3a4-cfbfad9f12ae", "dosage_form": "SPRAY, METERED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "67877-477", "generic_name": "Azelastine", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azelastine", "active_ingredients": [{"name": "AZELASTINE HYDROCHLORIDE", "strength": "137 ug/1"}], "application_number": "ANDA208156", "marketing_category": "ANDA", "marketing_start_date": "20170818", "listing_expiration_date": "20261231"}