🇺🇸
United States · US · US:50090-6327_dd1cf8de-0389-4e98-be80-dc164a6dbcff
Budesonide and Formoterol Fumarate Dihydrate
Orange BookUNIISPLATC A07EA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeA07EA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1150090632701 POUCH in 1 CARTON (50090-6327-0) / 1 AEROSOL in 1 POUCH
Annotations
UNII (FDA Substance ID)
Q3OKS62Q6X
BUDESONIDE
RxCUI 19831
Orange Book
N021929
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "Q3OKS62Q6X",
"rxcui": "19831",
"inchikey": "VOVIALXJUBGFJZ-KWVAZRHASA-N",
"display_name": "BUDESONIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "RESPIRATORY (INHALATION)",
"spl_meta": {
"dd352302-e2fe-4388-b4b0-00b34f6ebe48": {
"match": "brand_token",
"title": "BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE AEROSOL, METERED [TEVA PHARMACEUTICALS, INC.]",
"spl_version": "2",
"published_date": "2026-05-29"
}
},
"productid": "50090-6327_dd1cf8de-0389-4e98-be80-dc164a6dbcff",
"productndc": "50090-6327",
"dosage_form": "AEROSOL",
"orange_book": {
"appl_no": "021929",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "0.08MG/INH;0.0045MG/INH",
"product_no": "001",
"approval_date": "Jul 21, 2006"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "0.16MG/INH;0.0045MG/INH",
"product_no": "002",
"approval_date": "Jul 21, 2006"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BUDESONIDE; FORMOTEROL FUMARATE",
"proprietary_name": "Budesonide and Formoterol Fumarate Dihydrate",
"active_ingred_unit": "ug/1; ug/1",
"application_number": "NDA021929",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "Budesonide and Formoterol Fumarate Dihydrate",
"start_marketing_date": "20200103",
"active_numerator_strength": "160; 4.5"
}Related drugs
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