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United States · US · US:49502-605_4607ec7c-6203-4e4b-877f-c6cb03c15590
Perforomist
Orange BookUNIISPLATC R03AC13
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerViatris Specialty LLC
CountryUS (United States)
ATC codeR03AC13
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11495026053030 POUCH in 1 CARTON (49502-605-30) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL
- ndc11495026056160 POUCH in 1 CARTON (49502-605-61) / 1 VIAL in 1 POUCH (49502-605-95) / 2 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
W34SHF8J2K
FORMOTEROL FUMARATE
RxCUI 998038
Orange Book
N022007
AN
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": {
"fb2fe258-fe2e-47f6-8adf-ca75bf6f90af": {
"match": "brand_token",
"title": "PERFOROMIST (FORMOTEROL FUMARATE DIHYDRATE) SOLUTION [VIATRIS SPECIALTY LLC]",
"spl_version": "22",
"published_date": "2025-02-13"
}
},
"productid": "49502-605_4607ec7c-6203-4e4b-877f-c6cb03c15590",
"productndc": "49502-605",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "022007",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AN",
"strength": "0.02MG/2ML",
"product_no": "001",
"approval_date": "May 11, 2007"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FORMOTEROL FUMARATE",
"proprietary_name": "Perforomist",
"active_ingred_unit": "ug/2mL",
"application_number": "NDA022007",
"marketing_category": "NDA",
"nonproprietary_name": "formoterol fumarate dihydrate",
"start_marketing_date": "20071001",
"active_numerator_strength": "20"
}Related drugs
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