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United States · US · US:0310-7372_b500fba8-8294-4c20-b51e-2ce674acf1b3
Budesonide and Formoterol Fumarate Dihydrate
Orange BookUNIISPLATC A07EA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAstraZeneca Pharmaceuticals LP
CountryUS (United States)
ATC codeA07EA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1103107372201 POUCH in 1 CARTON (0310-7372-20) / 1 CANISTER in 1 POUCH / 120 AEROSOL in 1 CANISTER
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": "0310-7372_b500fba8-8294-4c20-b51e-2ce674acf1b3",
"productndc": "0310-7372",
"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": "80; 4.5"
}Related drugs
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