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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

  • ndc11
    6126950906
    1 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"
}

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