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United States · US · US:0186-0370_1f05ded1-7d31-4cfc-8537-0e75f99ad452

SYMBICORT

Orange BookUNIISPLATC A07EA

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

Identification

ManufacturerAstraZeneca Pharmaceuticals LP
CountryUS (United States)
ATC codeA07EA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0186037020
    1 POUCH in 1 CARTON (0186-0370-20) / 1 CANISTER in 1 POUCH / 120 AEROSOL in 1 CANISTER
  • ndc11
    0186037028
    1 POUCH in 1 CARTON (0186-0370-28) / 1 CANISTER in 1 POUCH / 60 AEROSOL in 1 CANISTER

Annotations

UNII (FDA Substance ID)
Q3OKS62Q6X
BUDESONIDE
RxCUI 19831
Orange Book
N021929
ABAB
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": {
    "a645756c-c692-4bc6-a858-7e7e249561bd": {
      "match": "brand_token",
      "title": "SYMBICORT (BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE) AEROSOL [SPORTPHARM LLC]",
      "spl_version": "1",
      "published_date": "2026-03-16"
    }
  },
  "productid": "0186-0370_1f05ded1-7d31-4cfc-8537-0e75f99ad452",
  "productndc": "0186-0370",
  "dosage_form": "AEROSOL",
  "orange_book": {
    "appl_no": "021929",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.08MG/INH;0.0045MG/INH",
        "product_no": "001",
        "approval_date": "Jul 21, 2006"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.16MG/INH;0.0045MG/INH",
        "product_no": "002",
        "approval_date": "Jul 21, 2006"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUDESONIDE; FORMOTEROL FUMARATE",
  "proprietary_name": "SYMBICORT",
  "active_ingred_unit": "ug/1; ug/1",
  "application_number": "NDA021929",
  "marketing_category": "NDA",
  "nonproprietary_name": "Budesonide and Formoterol Fumarate Dihydrate",
  "start_marketing_date": "20070529",
  "active_numerator_strength": "160; 4.5"
}

Related drugs

Other records sharing ATC code A07EA.

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