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United States · US · US:0781-7517_89c0a36a-04f4-458f-8518-6a9a92168b2e
Budesonide
Orange BookUNIISPLATC A07EA06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSandoz Inc
CountryUS (United States)
ATC codeA07EA06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1107817517876 POUCH in 1 CARTON (0781-7517-87) / 5 AMPULE in 1 POUCH (0781-7517-14) / 2 mL in 1 AMPULE (0781-7517-72)
Annotations
UNII (FDA Substance ID)
Q3OKS62Q6X
BUDESONIDE
RxCUI 19831
Orange Book
A201966
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": "0781-7517_89c0a36a-04f4-458f-8518-6a9a92168b2e",
"productndc": "0781-7517",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "201966",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "1MG/2ML",
"product_no": "001",
"approval_date": "Sep 27, 2013"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "0.5MG/2ML",
"product_no": "002",
"approval_date": "Sep 27, 2013"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "0.25MG/2ML",
"product_no": "003",
"approval_date": "Sep 27, 2013"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BUDESONIDE",
"proprietary_name": "Budesonide",
"active_ingred_unit": "mg/2mL",
"application_number": "ANDA201966",
"marketing_category": "ANDA",
"nonproprietary_name": "Budesonide",
"start_marketing_date": "20150724",
"active_numerator_strength": "1"
}Related drugs
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