🇺🇸
United States · US · US:50742-394_36df181b-7f3a-3ad2-e063-6294a90ab756
Formoterol Fumarate
Orange BookUNIISPLATC R03AC13
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerIngenus Pharmaceuticals, LLC
CountryUS (United States)
ATC codeR03AC13
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11507423943030 POUCH in 1 CARTON (50742-394-30) / 1 VIAL, SINGLE-DOSE in 1 POUCH (50742-394-01) / 2 mL in 1 VIAL, SINGLE-DOSE
- ndc11507423946060 POUCH in 1 CARTON (50742-394-60) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
W34SHF8J2K
FORMOTEROL FUMARATE
RxCUI 998038
Orange Book
A216426
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": "50742-394_36df181b-7f3a-3ad2-e063-6294a90ab756",
"productndc": "50742-394",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "216426",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AN",
"strength": "0.02MG/2ML",
"product_no": "001",
"approval_date": "Oct 22, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FORMOTEROL FUMARATE",
"proprietary_name": "Formoterol Fumarate",
"active_ingred_unit": "mg/2mL",
"application_number": "ANDA216426",
"marketing_category": "ANDA",
"nonproprietary_name": "Formoterol Fumarate",
"start_marketing_date": "20250605",
"active_numerator_strength": ".02"
}Related drugs
Other records sharing ATC code R03AC13.
- PLAtimosChiesi Farmaceutici S.p.A.
- DKAtimosOrifarm A/S
- CZATIMOSChiesi Pharmaceuticals GmbH, Vídeň
- CZATIMOSChiesi Pharmaceuticals GmbH, Vídeň
- CZATIMOSChiesi Pharmaceuticals GmbH, Vídeň
- NLAtimos 12 microgram, aërosol, oplossingBModesto B.V.
- NLAtimos 12 microgram, aërosol, oplossingEU-Pharma B.V.
- NLAtimos 12 microgram, aërosol, oplossingEuro Registratie Collectief B.V.
Access this data programmatically
Query Formoterol Fumarate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.