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United States · US · US:50090-6586_6cd18e8a-1a34-4e9e-914c-198ef79a8a83

Budesonide

Orange BookUNIISPLATC A07EA06

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeA07EA06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009065860
    6 POUCH in 1 CARTON (50090-6586-0) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE

Annotations

UNII (FDA Substance ID)
Q3OKS62Q6X
BUDESONIDE
RxCUI 19831
Orange Book
A211922
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": {
    "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": "50090-6586_6cd18e8a-1a34-4e9e-914c-198ef79a8a83",
  "productndc": "50090-6586",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "211922",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AN",
        "strength": "0.25MG/2ML",
        "product_no": "001",
        "approval_date": "Apr 14, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AN",
        "strength": "0.5MG/2ML",
        "product_no": "002",
        "approval_date": "Apr 14, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AN",
        "strength": "1MG/2ML",
        "product_no": "003",
        "approval_date": "Apr 14, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUDESONIDE",
  "proprietary_name": "Budesonide",
  "active_ingred_unit": "mg/2mL",
  "application_number": "ANDA211922",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Budesonide",
  "start_marketing_date": "20210501",
  "active_numerator_strength": ".5"
}

Related drugs

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