azelastine hydrochloride and fluticasone propionate

Generic: azelastine hydrochloride, fluticasone propionate

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azelastine hydrochloride and fluticasone propionate
Generic Name azelastine hydrochloride, fluticasone propionate
Labeler bryant ranch prepack
Dosage Form SPRAY, METERED
Routes
NASAL
Active Ingredients

azelastine hydrochloride 137 ug/1, fluticasone propionate 50 ug/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-8612
Product ID 63629-8612_2cb5fed9-e2fc-448c-87df-83af32f6bc78
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208111
Listing Expiration 2026-12-31
Marketing Start 2021-03-01

Pharmacologic Class

Classes
corticosteroid hormone receptor agonists [moa] corticosteroid [epc] histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636298612
Hyphenated Format 63629-8612

Supplemental Identifiers

RxCUI
1797847
UNII
0L591QR10I O2GMZ0LF5W

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 and fluticasone propionate (source: ndc)
Generic Name azelastine hydrochloride, fluticasone propionate (source: ndc)
Application Number ANDA208111 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 137 ug/1
  • 50 ug/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (63629-8612-1) / 120 SPRAY, METERED in 1 BOTTLE
source: ndc

Packages (1)

63629-8612-1 1 BOTTLE in 1 CARTON (63629-8612-1) / 120 SPRAY, METERED in 1 BOTTLE

Ingredients (2)

azelastine hydrochloride (137 ug/1) fluticasone propionate (50 ug/1)

Linked Drug Pages (1)

AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "2cb5fed9-e2fc-448c-87df-83af32f6bc78", "openfda": {"unii": ["0L591QR10I", "O2GMZ0LF5W"], "rxcui": ["1797847"], "spl_set_id": ["1a930a09-db26-40aa-bb05-123a0d7182bc"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (63629-8612-1)  / 120 SPRAY, METERED in 1 BOTTLE", "package_ndc": "63629-8612-1", "marketing_start_date": "20210301"}], "brand_name": "AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE", "product_id": "63629-8612_2cb5fed9-e2fc-448c-87df-83af32f6bc78", "dosage_form": "SPRAY, METERED", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "63629-8612", "generic_name": "azelastine hydrochloride, fluticasone propionate", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE", "active_ingredients": [{"name": "AZELASTINE HYDROCHLORIDE", "strength": "137 ug/1"}, {"name": "FLUTICASONE PROPIONATE", "strength": "50 ug/1"}], "application_number": "ANDA208111", "marketing_category": "ANDA", "marketing_start_date": "20210301", "listing_expiration_date": "20261231"}