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United States · US · US:76282-640_c53a81a4-fad8-4587-ac13-cc4de968485e
Budesonide
Orange BookUNIISPLATC A07EA06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerExelan Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA07EA06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1176282640386 POUCH in 1 CARTON (76282-640-38) / 5 AMPULE in 1 POUCH (76282-640-37) / 2 mL in 1 AMPULE
Annotations
UNII (FDA Substance ID)
Q3OKS62Q6X
BUDESONIDE
RxCUI 19831
Orange Book
A205710
ANANAN
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": "76282-640_c53a81a4-fad8-4587-ac13-cc4de968485e",
"productndc": "76282-640",
"dosage_form": "INHALANT",
"orange_book": {
"appl_no": "205710",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AN",
"strength": "0.25MG/2ML",
"product_no": "001",
"approval_date": "Nov 16, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AN",
"strength": "0.5MG/2ML",
"product_no": "002",
"approval_date": "Nov 16, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AN",
"strength": "1MG/2ML",
"product_no": "003",
"approval_date": "Nov 16, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BUDESONIDE",
"proprietary_name": "Budesonide",
"active_ingred_unit": "mg/2mL",
"application_number": "ANDA205710",
"marketing_category": "ANDA",
"nonproprietary_name": "Budesonide",
"start_marketing_date": "20190417",
"active_numerator_strength": ".25"
}Related drugs
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