xhance

Generic: fluticasone propionate

Labeler: optinose us, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name xhance
Generic Name fluticasone propionate
Labeler optinose us, inc.
Dosage Form SPRAY, METERED
Routes
NASAL
Active Ingredients

fluticasone propionate 93 ug/1

Manufacturer
OptiNose US, Inc.

Identifiers & Regulatory

Product NDC 71143-375
Product ID 71143-375_4650025f-0f79-6a7b-e063-6294a90ab7f6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209022
Marketing Start 2017-10-03
Marketing End 2028-07-31

Pharmacologic Class

Classes
corticosteroid hormone receptor agonists [moa] corticosteroid [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71143375
Hyphenated Format 71143-375

Supplemental Identifiers

RxCUI
1946583 1946589
UPC
0371143375011
UNII
O2GMZ0LF5W

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 xhance (source: ndc)
Generic Name fluticasone propionate (source: ndc)
Application Number NDA209022 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 93 ug/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (71143-375-01) / 120 SPRAY, METERED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (71143-375-98) / 28 SPRAY, METERED in 1 BOTTLE
source: ndc

Packages (2)

71143-375-01 1 BOTTLE in 1 CARTON (71143-375-01) / 120 SPRAY, METERED in 1 BOTTLE 71143-375-98 1 BOTTLE in 1 CARTON (71143-375-98) / 28 SPRAY, METERED in 1 BOTTLE

Ingredients (1)

fluticasone propionate (93 ug/1)

Linked Drug Pages (1)

XHANCE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "4650025f-0f79-6a7b-e063-6294a90ab7f6", "openfda": {"upc": ["0371143375011"], "unii": ["O2GMZ0LF5W"], "rxcui": ["1946583", "1946589"], "spl_set_id": ["c79bbb9f-e483-4093-8c92-ea978e7bf278"], "manufacturer_name": ["OptiNose US, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (71143-375-01)  / 120 SPRAY, METERED in 1 BOTTLE", "package_ndc": "71143-375-01", "marketing_end_date": "20280731", "marketing_start_date": "20171003"}, {"sample": true, "description": "1 BOTTLE in 1 CARTON (71143-375-98)  / 28 SPRAY, METERED in 1 BOTTLE", "package_ndc": "71143-375-98", "marketing_end_date": "20270731", "marketing_start_date": "20190301"}], "brand_name": "XHANCE", "product_id": "71143-375_4650025f-0f79-6a7b-e063-6294a90ab7f6", "dosage_form": "SPRAY, METERED", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "71143-375", "generic_name": "fluticasone propionate", "labeler_name": "OptiNose US, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "XHANCE", "active_ingredients": [{"name": "FLUTICASONE PROPIONATE", "strength": "93 ug/1"}], "application_number": "NDA209022", "marketing_category": "NDA", "marketing_end_date": "20280731", "marketing_start_date": "20171003"}