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United States · US · US:42571-463_22feda0b-260a-8cd2-e063-6394a90af8eb
Formoterol fumarate
Orange BookUNIISPLATC R03AC13
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMicro Labs Limited
CountryUS (United States)
ATC codeR03AC13
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11425714636260 POUCH in 1 CARTON (42571-463-62) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL
- ndc11425714637330 POUCH in 1 CARTON (42571-463-73) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
W34SHF8J2K
FORMOTEROL FUMARATE
RxCUI 998038
Orange Book
A218304
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": "42571-463_22feda0b-260a-8cd2-e063-6394a90af8eb",
"productndc": "42571-463",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "218304",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AN",
"strength": "0.02MG/2ML",
"product_no": "001",
"approval_date": "Jun 26, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FORMOTEROL FUMARATE",
"proprietary_name": "Formoterol fumarate",
"active_ingred_unit": "ug/2mL",
"application_number": "ANDA218304",
"marketing_category": "ANDA",
"nonproprietary_name": "Formoterol fumarate",
"start_marketing_date": "20241001",
"active_numerator_strength": "20"
}Related drugs
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