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United States · US · US:0378-1631_db19667d-88cd-47ab-adb5-894959822801
FORMOTEROL FUMARATE
Orange BookUNIISPLATC R03AC13
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeR03AC13
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11037816319160 POUCH in 1 CARTON (0378-1631-91) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL
- ndc11037816319330 POUCH in 1 CARTON (0378-1631-93) / 1 VIAL in 1 POUCH (0378-1631-32) / 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": {
"4dbb9620-5731-40d9-8258-2977ecc781c4": {
"match": "brand_token",
"title": "FORMOTEROL FUMARATE (FORMOTEROL FUMARATE DIHYDRATE) SOLUTION [NORTHSTAR RXLLC]",
"spl_version": "2",
"published_date": "2026-05-04"
}
},
"productid": "0378-1631_db19667d-88cd-47ab-adb5-894959822801",
"productndc": "0378-1631",
"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": "FORMOTEROL FUMARATE",
"active_ingred_unit": "ug/2mL",
"application_number": "NDA022007",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "formoterol fumarate dihydrate",
"start_marketing_date": "20210622",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code R03AC13.
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- NLAtimos 12 microgram, aërosol, oplossingBModesto B.V.
- NLAtimos 12 microgram, aërosol, oplossingEU-Pharma B.V.
- NLAtimos 12 microgram, aërosol, oplossingEuro Registratie Collectief B.V.
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