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United States · US · US:76204-030_459f276c-d771-4ae9-e063-6394a90a3476
Formoterol Fumarate Inhalation Solution
Orange BookUNIISPLATC R03AC13
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRitedose Pharmaceuticals, LLC
CountryUS (United States)
ATC codeR03AC13
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11762040300130 POUCH in 1 CARTON (76204-030-01) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL
- ndc11762040300260 POUCH in 1 CARTON (76204-030-02) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
W34SHF8J2K
FORMOTEROL FUMARATE
RxCUI 998038
Orange Book
A216486
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": "76204-030_459f276c-d771-4ae9-e063-6394a90a3476",
"productndc": "76204-030",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "216486",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AN",
"strength": "0.02MG/2ML",
"product_no": "001",
"approval_date": "Nov 25, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FORMOTEROL FUMARATE",
"proprietary_name": "Formoterol Fumarate Inhalation Solution",
"active_ingred_unit": "ug/2mL",
"application_number": "ANDA216486",
"marketing_category": "ANDA",
"nonproprietary_name": "formoterol fumarate dihydrate",
"start_marketing_date": "20250314",
"active_numerator_strength": "20"
}Related drugs
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