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United States · US · US:85612-011_a035bb8f-2fe9-4a86-af53-32196ffc0361
PULMICORT
Orange BookUNIISPLATC A07EA06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRubicon Holdings Inc.
CountryUS (United States)
ATC codeA07EA06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1185612011011 INHALER in 1 CARTON (85612-011-01) / 120 AEROSOL, POWDER in 1 INHALER
Annotations
UNII (FDA Substance ID)
Q3OKS62Q6X
BUDESONIDE
RxCUI 19831
Orange Book
N021949
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": {
"5d0c6c7e-2f53-4238-ab34-bd8cf49d8a66": {
"match": "brand_token",
"title": "PULMICORT FLEXHALER (BUDESONIDE) AEROSOL, POWDER [A-S MEDICATION SOLUTIONS]",
"spl_version": "2",
"published_date": "2026-01-30"
}
},
"productid": "85612-011_a035bb8f-2fe9-4a86-af53-32196ffc0361",
"productndc": "85612-011",
"dosage_form": "AEROSOL, POWDER",
"orange_book": {
"appl_no": "021949",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.08MG/INH",
"product_no": "001",
"approval_date": "Jul 12, 2006"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.16MG/INH",
"product_no": "002",
"approval_date": "Jul 12, 2006"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BUDESONIDE",
"proprietary_name": "PULMICORT",
"active_ingred_unit": "ug/1",
"application_number": "NDA021949",
"marketing_category": "NDA",
"nonproprietary_name": "Budesonide",
"start_marketing_date": "20250701",
"active_numerator_strength": "180"
}Related drugs
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