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United States · US · US:0480-3080_3dc30116-6267-434d-bfef-24a1dcb253db
Budesonide and formoterol fumarate dihydrate
Orange BookUNIISPLATC A07EA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA07EA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1104803080311 POUCH in 1 CARTON (0480-3080-31) / 1 CANISTER in 1 POUCH / 120 AEROSOL, METERED in 1 CANISTER
Annotations
UNII (FDA Substance ID)
Q3OKS62Q6X
BUDESONIDE
RxCUI 19831
Orange Book
A212212
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": "0480-3080_3dc30116-6267-434d-bfef-24a1dcb253db",
"productndc": "0480-3080",
"dosage_form": "AEROSOL, METERED",
"orange_book": {
"appl_no": "212212",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.08MG/INH;0.0045MG/INH",
"product_no": "001",
"approval_date": "Apr 23, 2026"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.16MG/INH;0.0045MG/INH",
"product_no": "002",
"approval_date": "Apr 23, 2026"
}
],
"appl_type": "A"
},
"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": "ANDA212212",
"marketing_category": "ANDA",
"nonproprietary_name": "Budesonide and formoterol fumarate dihydrate",
"start_marketing_date": "20260527",
"active_numerator_strength": "80; 4.5"
}Related drugs
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