🇺🇸
United States · US · US:50090-7173_5839c766-0032-4869-9c92-60531bcb183f
Budesonide
Orange BookUNIISPLATC A07EA06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeA07EA06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11500907173030 AMPULE in 1 CARTON (50090-7173-0) / 2 mL in 1 AMPULE
Annotations
UNII (FDA Substance ID)
Q3OKS62Q6X
BUDESONIDE
RxCUI 19831
Orange Book
A078202
ANAN
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": "50090-7173_5839c766-0032-4869-9c92-60531bcb183f",
"productndc": "50090-7173",
"dosage_form": "INHALANT",
"orange_book": {
"appl_no": "078202",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AN",
"strength": "0.25MG/2ML",
"product_no": "001",
"approval_date": "Mar 30, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AN",
"strength": "0.5MG/2ML",
"product_no": "002",
"approval_date": "Mar 30, 2009"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BUDESONIDE",
"proprietary_name": "Budesonide",
"active_ingred_unit": "mg/2mL",
"application_number": "ANDA078202",
"marketing_category": "ANDA",
"nonproprietary_name": "BUDESONIDE",
"start_marketing_date": "20131001",
"active_numerator_strength": ".25"
}Related drugs
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