🇺🇸
United States · US · US:0378-7503_c9fc3541-8929-4517-9a4e-969fca81e390
BREYNA
Orange BookUNIISPLATC A07EA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeA07EA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1103787503321 POUCH in 1 CARTON (0378-7503-32) / 1 CANISTER in 1 POUCH / 120 AEROSOL, METERED in 1 CANISTER
Annotations
UNII (FDA Substance ID)
Q3OKS62Q6X
BUDESONIDE
RxCUI 19831
Orange Book
A211699
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": {
"dc529fc4-bddb-4673-8202-dc401f86166f": {
"match": "brand_token",
"title": "BREYNA (BUDESONIDE AND FORMOTEROL FUMARATE) AEROSOL, METERED [MYLAN PHARMACEUTICALS INC.]",
"spl_version": "5",
"published_date": "2026-03-18"
}
},
"productid": "0378-7503_c9fc3541-8929-4517-9a4e-969fca81e390",
"productndc": "0378-7503",
"dosage_form": "AEROSOL, METERED",
"orange_book": {
"appl_no": "211699",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.08MG/INH;0.0045MG/INH",
"product_no": "001",
"approval_date": "Mar 15, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.16MG/INH;0.0045MG/INH",
"product_no": "002",
"approval_date": "Mar 15, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BUDESONIDE; FORMOTEROL FUMARATE",
"proprietary_name": "BREYNA",
"active_ingred_unit": "ug/1; ug/1",
"application_number": "ANDA211699",
"marketing_category": "ANDA",
"nonproprietary_name": "Budesonide and Formoterol Fumarate",
"start_marketing_date": "20230731",
"active_numerator_strength": "160; 4.5"
}Related drugs
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