🇺🇸
United States · US · US:0310-4600_90a24746-75fb-490b-9e0d-7e33a5d8f00a
BEVESPI AEROSPHERE
Orange BookUNIISPLATC R03AC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAstraZeneca Pharmaceuticals LP
CountryUS (United States)
ATC codeR03AC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110310460012120 AEROSOL, METERED in 1 INHALER (0310-4600-12)
Annotations
UNII (FDA Substance ID)
W34SHF8J2K
FORMOTEROL FUMARATE
RxCUI 998038
Orange Book
N208294
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "W34SHF8J2K",
"rxcui": "998038",
"inchikey": "RATSWNOMCHFQGJ-TUYNVFRMSA-N;RATSWNOMCHFQGJ-AYJOUMQSSA-N",
"display_name": "FORMOTEROL FUMARATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "RESPIRATORY (INHALATION)",
"spl_meta": {
"ae02436e-9528-490e-a844-0c0f6f2843f9": {
"match": "brand_token",
"title": "BEVESPI AEROSPHERE (GLYCOPYRROLATE AND FORMOTEROL FUMARATE) AEROSOL, METERED [ASTRAZENECA PHARMACEUTICALS LP]",
"spl_version": "26",
"published_date": "2025-12-19"
}
},
"productid": "0310-4600_90a24746-75fb-490b-9e0d-7e33a5d8f00a",
"productndc": "0310-4600",
"dosage_form": "AEROSOL, METERED",
"orange_book": {
"appl_no": "208294",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.0048MG/INH;0.0090MG/INH",
"product_no": "001",
"approval_date": "Apr 25, 2016"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FORMOTEROL FUMARATE; GLYCOPYRROLATE",
"proprietary_name": "BEVESPI AEROSPHERE",
"active_ingred_unit": "ug/1; ug/1",
"application_number": "NDA208294",
"marketing_category": "NDA",
"nonproprietary_name": "Glycopyrrolate and formoterol fumarate",
"start_marketing_date": "20161003",
"active_numerator_strength": "4.8; 9"
}Related drugs
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