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United States · US · US:0009-3794_1cc20301-7541-43e5-8034-8306028c50a4

Corvert

Orange BookUNIISPLATC C01BD05

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

Identification

ManufacturerPharmacia & Upjohn Company LLC
CountryUS (United States)
ATC codeC01BD05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0009379422
    1 VIAL, SINGLE-DOSE in 1 CARTON (0009-3794-22) / 10 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
9L5X4M5L6I
IBUTILIDE FUMARATE
RxCUI 51256
Orange Book
N020491
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "9L5X4M5L6I",
    "rxcui": "51256",
    "inchikey": "PCIOHQNIRPWFMV-WXXKFALUSA-N",
    "display_name": "IBUTILIDE FUMARATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "b7d717ed-022d-4459-b5e6-098c2a8b7427": {
      "match": "brand_token",
      "title": "CORVERT (IBUTILIDE FUMARATE) INJECTION, SOLUTION [PHARMACIA & UPJOHN COMPANY LLC]",
      "spl_version": "11",
      "published_date": "2024-01-26"
    }
  },
  "productid": "0009-3794_1cc20301-7541-43e5-8034-8306028c50a4",
  "productndc": "0009-3794",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "020491",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "0.1MG/ML",
        "product_no": "001",
        "approval_date": "Dec 28, 1995"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IBUTILIDE FUMARATE",
  "proprietary_name": "Corvert",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA020491",
  "marketing_category": "NDA",
  "nonproprietary_name": "ibutilide fumarate",
  "start_marketing_date": "19951228",
  "active_numerator_strength": ".1"
}

Related drugs

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