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United States · US · US:49035-703_fce82ec5-1379-4faa-a710-f989c6c9ca5a

Budesonide

Orange BookUNIISPLATC A07EA06

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

Identification

ManufacturerEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
CountryUS (United States)
ATC codeA07EA06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4903570301
    1 BOTTLE, SPRAY in 1 BOTTLE, SPRAY (49035-703-01) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY

Annotations

UNII (FDA Substance ID)
Q3OKS62Q6X
BUDESONIDE
RxCUI 19831
Orange Book
A078949
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": "NASAL",
  "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": "49035-703_fce82ec5-1379-4faa-a710-f989c6c9ca5a",
  "productndc": "49035-703",
  "dosage_form": "SPRAY, METERED",
  "orange_book": {
    "appl_no": "078949",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.032MG/SPRAY",
        "product_no": "002",
        "approval_date": "Nov 20, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "BUDESONIDE",
  "proprietary_name": "Budesonide",
  "active_ingred_unit": "ug/1",
  "application_number": "ANDA078949",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Budesonide",
  "start_marketing_date": "20250701",
  "active_numerator_strength": "32"
}

Related drugs

Other records sharing ATC code A07EA06.

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