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United States · US · US:0093-4061_0ecd7fc0-7e29-4502-91ff-a0ead5a5a1f8
Formoterol fumarate
Orange BookUNIISPLATC R03AC13
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeR03AC13
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11009340610660 POUCH in 1 CARTON (0093-4061-06) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL
- ndc11009340613030 POUCH in 1 CARTON (0093-4061-30) / 1 VIAL in 1 POUCH (0093-4061-19) / 2 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
W34SHF8J2K
FORMOTEROL FUMARATE
RxCUI 998038
Orange Book
A091141
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": "0093-4061_0ecd7fc0-7e29-4502-91ff-a0ead5a5a1f8",
"productndc": "0093-4061",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "091141",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AN",
"strength": "0.02MG/2ML",
"product_no": "001",
"approval_date": "Jun 22, 2021"
}
],
"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": "ANDA091141",
"marketing_category": "ANDA",
"nonproprietary_name": "Formoterol fumarate",
"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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