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United States · US · US:0487-9601_32635b5d-cc62-710c-e063-6294a90a2802
Budesonide
Orange BookUNIISPLATC A07EA06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNephron Pharmaceuticals Corporation
CountryUS (United States)
ATC codeA07EA06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1104879601016 POUCH in 1 CARTON (0487-9601-01) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE
- ndc11048796013030 POUCH in 1 CARTON (0487-9601-30) / 1 AMPULE in 1 POUCH / 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": "0487-9601_32635b5d-cc62-710c-e063-6294a90a2802",
"productndc": "0487-9601",
"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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