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United States · US · US:70748-261_7c2eac38-f571-486e-91bb-60f913af5bbc
formoterol fumarate
Orange BookUNIISPLATC R03AC13
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLupin Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeR03AC13
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11707482613030 POUCH in 1 CARTON (70748-261-30) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL
- ndc11707482616060 POUCH in 1 CARTON (70748-261-60) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
W34SHF8J2K
FORMOTEROL FUMARATE
RxCUI 998038
Orange Book
A215053
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": "70748-261_7c2eac38-f571-486e-91bb-60f913af5bbc",
"productndc": "70748-261",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "215053",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AN",
"strength": "0.02MG/2ML",
"product_no": "001",
"approval_date": "Aug 22, 2022"
}
],
"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": "ANDA215053",
"marketing_category": "ANDA",
"nonproprietary_name": "formoterol fumarate",
"start_marketing_date": "20221128",
"active_numerator_strength": "20"
}Related drugs
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