Budesonide

Orange BookUNIISPLATC A07EA06

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerCipla USA Inc.

CountryUS (United States)

ATC codeA07EA06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6909732153
30 POUCH in 1 CARTON (69097-321-53) / 1 AMPULE in 1 POUCH (69097-321-32) / 2 mL in 1 AMPULE
ndc11
6909732187
6 POUCH in 1 CARTON (69097-321-87) / 5 AMPULE in 1 POUCH (69097-321-86) / 2 mL in 1 AMPULE

Annotations

UNII (FDA Substance ID)

Q3OKS62Q6X

BUDESONIDE

RxCUI 19831

Orange Book

A205710

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": "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": "69097-321_58158207-1901-422d-8d42-323dab348a01",
  "productndc": "69097-321",
  "dosage_form": "INHALANT",
  "orange_book": {
    "appl_no": "205710",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AN",
        "strength": "0.25MG/2ML",
        "product_no": "001",
        "approval_date": "Nov 16, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AN",
        "strength": "0.5MG/2ML",
        "product_no": "002",
        "approval_date": "Nov 16, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AN",
        "strength": "1MG/2ML",
        "product_no": "003",
        "approval_date": "Nov 16, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUDESONIDE",
  "proprietary_name": "Budesonide",
  "active_ingred_unit": "mg/2mL",
  "application_number": "ANDA205710",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Budesonide",
  "start_marketing_date": "20171116",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code A07EA06.

Access this data programmatically

Query Budesonide and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs