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United States · US · US:0574-9855_d502ff68-2ba4-461c-a739-9012f4f09dec
budesonide
Orange BookUNIISPLATC A07EA06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPadagis US LLC
CountryUS (United States)
ATC codeA07EA06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1105749855101 BOTTLE in 1 CARTON (0574-9855-10) / 100 CAPSULE in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
Q3OKS62Q6X
BUDESONIDE
RxCUI 19831
Orange Book
N021324
AB
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": "ORAL",
"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": "0574-9855_d502ff68-2ba4-461c-a739-9012f4f09dec",
"productndc": "0574-9855",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "021324",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "3MG",
"product_no": "001",
"approval_date": "Oct 2, 2001"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BUDESONIDE",
"proprietary_name": "budesonide",
"active_ingred_unit": "mg/1",
"application_number": "NDA021324",
"marketing_category": "NDA",
"nonproprietary_name": "budesonide",
"start_marketing_date": "20180629",
"active_numerator_strength": "3"
}Related drugs
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