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United States · US · US:63629-8294_a249352d-1d2d-4646-8a2b-81a2e37b7e86
Budesonide
Orange BookUNIISPLATC A07EA06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeA07EA06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11636298294130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63629-8294-1)
Annotations
UNII (FDA Substance ID)
Q3OKS62Q6X
BUDESONIDE
RxCUI 19831
Orange Book
A206200
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": "63629-8294_a249352d-1d2d-4646-8a2b-81a2e37b7e86",
"productndc": "63629-8294",
"dosage_form": "CAPSULE, DELAYED RELEASE",
"orange_book": {
"appl_no": "206200",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "3MG",
"product_no": "001",
"approval_date": "Jul 31, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BUDESONIDE",
"proprietary_name": "Budesonide",
"active_ingred_unit": "mg/1",
"application_number": "ANDA206200",
"marketing_category": "ANDA",
"nonproprietary_name": "Budesonide",
"start_marketing_date": "20170915",
"active_numerator_strength": "3"
}Related drugs
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