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United States · US · US:59651-585_c70c734f-2431-4414-bb94-4adda4985e5d

BUDESONIDE

Orange BookUNIISPLATC A07EA06

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

Identification

ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeA07EA06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5965158530
    6 POUCH in 1 CARTON (59651-585-30) / 5 AMPULE in 1 POUCH (59651-585-05) / 2 mL in 1 AMPULE

Annotations

UNII (FDA Substance ID)
Q3OKS62Q6X
BUDESONIDE
RxCUI 19831
Orange Book
A216667
AN
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": "59651-585_c70c734f-2431-4414-bb94-4adda4985e5d",
  "productndc": "59651-585",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "216667",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AN",
        "strength": "0.5MG/2ML",
        "product_no": "001",
        "approval_date": "Nov 29, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUDESONIDE",
  "proprietary_name": "BUDESONIDE",
  "active_ingred_unit": "mg/2mL",
  "application_number": "ANDA216667",
  "marketing_category": "ANDA",
  "nonproprietary_name": "BUDESONIDE",
  "start_marketing_date": "20231129",
  "active_numerator_strength": ".5"
}

Related drugs

Other records sharing ATC code A07EA06.

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