🇺🇸
United States · US · US:61269-509_f6ce08aa-a011-4120-a609-d542a4db8c15
PULMICORT
Orange BookUNIISPLATC A07EA06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerH2-Pharma LLC
CountryUS (United States)
ATC codeA07EA06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1161269509061 INHALER in 1 CARTON (61269-509-06) / 60 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": "61269-509_f6ce08aa-a011-4120-a609-d542a4db8c15",
"productndc": "61269-509",
"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": "20070319",
"active_numerator_strength": "90"
}Related drugs
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