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United States · US · US:0186-1990_76a8044c-b6f4-4da4-b855-a281fdca66b4
PULMICORT RESPULES
Orange BookUNIISPLATC A07EA06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAstraZeneca Pharmaceuticals LP
CountryUS (United States)
ATC codeA07EA06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1101861990046 POUCH in 1 CARTON (0186-1990-04) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE
Annotations
UNII (FDA Substance ID)
Q3OKS62Q6X
BUDESONIDE
RxCUI 19831
Orange Book
N020929
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": "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": "0186-1990_76a8044c-b6f4-4da4-b855-a281fdca66b4",
"productndc": "0186-1990",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "020929",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AN",
"strength": "0.25MG/2ML",
"product_no": "001",
"approval_date": "Aug 8, 2000"
},
{
"rs": true,
"rld": true,
"te_code": "AN",
"strength": "0.5MG/2ML",
"product_no": "002",
"approval_date": "Aug 8, 2000"
},
{
"rs": true,
"rld": true,
"te_code": "AN",
"strength": "1MG/2ML",
"product_no": "003",
"approval_date": "Aug 8, 2000"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BUDESONIDE",
"proprietary_name": "PULMICORT RESPULES",
"active_ingred_unit": "mg/2mL",
"application_number": "NDA020929",
"marketing_category": "NDA",
"nonproprietary_name": "Budesonide",
"start_marketing_date": "20070917",
"active_numerator_strength": "1"
}Related drugs
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