🇺🇸
United States · US · US:70000-0703_7269e8c3-d42e-48c0-b9b7-34e531fc1ee4
leader fluticasone propionate
In shortageOrange BookUNIISPLATC D07AC17
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCardinal Health 110, LLC. dba Leader
CountryUS (United States)
ATC codeD07AC17
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1170000070311 BOTTLE, SPRAY in 1 CARTON (70000-0703-1) / 72 SPRAY, METERED in 1 BOTTLE, SPRAY
- ndc1170000070321 BOTTLE, SPRAY in 1 CARTON (70000-0703-2) / 144 SPRAY, METERED in 1 BOTTLE, SPRAY
Annotations
UNII (FDA Substance ID)
O2GMZ0LF5W
FLUTICASONE PROPIONATE
RxCUI 50121
Orange Book
A207957
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": {
"12971fb2-2314-4443-bf70-b7eb5859b148": {
"match": "brand_token",
"title": "LEADER MUCUS RELIEF D (GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, MULTILAYER, EXTENDED RELEASE [CARDINAL HEALTH 110, LLC. DBA LEADER]",
"spl_version": "3",
"published_date": "2026-06-01"
}
},
"productid": "70000-0703_7269e8c3-d42e-48c0-b9b7-34e531fc1ee4",
"productndc": "70000-0703",
"dosage_form": "SPRAY, METERED",
"orange_book": {
"appl_no": "207957",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "0.05MG/SPRAY",
"product_no": "001",
"approval_date": "May 26, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "FLUTICASONE PROPIONATE",
"shortage_reason": "Fluticasone Propionate; Salmeterol Xinafoate Powder",
"shortage_status": "current",
"proprietary_name": "leader fluticasone propionate",
"active_ingred_unit": "ug/1",
"application_number": "ANDA207957",
"marketing_category": "ANDA",
"nonproprietary_name": "Fluticasone propionate",
"start_marketing_date": "20240612",
"active_numerator_strength": "50"
}Related drugs
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