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United States · US · US:0591-2510_5b1c0fe2-b58d-43b4-8784-038653663c44

Budesonide

Orange BookUNIISPLATC A07EA06

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

Identification

ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeA07EA06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0591251030
    30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-2510-30)

Annotations

UNII (FDA Substance ID)
Q3OKS62Q6X
BUDESONIDE
RxCUI 19831
Orange Book
A205457
AB
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": "ORAL",
  "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": "0591-2510_5b1c0fe2-b58d-43b4-8784-038653663c44",
  "productndc": "0591-2510",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "205457",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "9MG",
        "product_no": "001",
        "approval_date": "Jul 3, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUDESONIDE",
  "proprietary_name": "Budesonide",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA205457",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Budesonide",
  "start_marketing_date": "20180705",
  "active_numerator_strength": "9"
}

Related drugs

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