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United States · US · US:71715-003_52325f1c-c606-cb28-e063-6294a90a8ecd
XHANCE
In shortageOrange BookUNIISPLATC D07AC17
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerParatek Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeD07AC17
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1171715003311 BOTTLE in 1 CARTON (71715-003-31) / 120 SPRAY, METERED in 1 BOTTLE
- ndc1171715003321 BOTTLE in 1 CARTON (71715-003-32) / 28 SPRAY, METERED in 1 BOTTLE
- ndc1171715003331 BOTTLE in 1 CARTON (71715-003-33) / 28 SPRAY, METERED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
O2GMZ0LF5W
FLUTICASONE PROPIONATE
RxCUI 50121
Orange Book
N209022
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Fluticasone Propionate; Salmeterol Xinafoate Powder
Raw payload (JSON)
{
"unii": {
"unii": "O2GMZ0LF5W",
"rxcui": "50121",
"inchikey": "WMWTYOKRWGGJOA-CENSZEJFSA-N",
"display_name": "FLUTICASONE PROPIONATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "NASAL",
"spl_meta": {
"44fcea33-8cfa-3a5c-e063-6394a90aafb2": {
"match": "brand_token",
"title": "XHANCE (FLUTICASONE PROPIONATE) SPRAY, METERED [PARATEK PHARMACEUTICALS, INC.]",
"spl_version": "2",
"published_date": "2026-05-21"
}
},
"productid": "71715-003_52325f1c-c606-cb28-e063-6294a90a8ecd",
"productndc": "71715-003",
"dosage_form": "SPRAY, METERED",
"orange_book": {
"appl_no": "209022",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.093MG",
"product_no": "001",
"approval_date": "Sep 18, 2017"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUTICASONE PROPIONATE",
"shortage_reason": "Fluticasone Propionate; Salmeterol Xinafoate Powder",
"shortage_status": "current",
"proprietary_name": "XHANCE",
"active_ingred_unit": "ug/1",
"application_number": "NDA209022",
"marketing_category": "NDA",
"nonproprietary_name": "fluticasone propionate",
"start_marketing_date": "20260112",
"active_numerator_strength": "93"
}Related drugs
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