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United States · US · US:0407-0690_dfe2f58c-7a8f-408a-9690-6300a49eda17

OMNISCAN

Orange BookUNIISPLATC V08CA03

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

Identification

ManufacturerGE Healthcare Inc.
CountryUS (United States)
ATC codeV08CA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    0407069010
    10 VIAL in 1 BOX (0407-0690-10) / 10 mL in 1 VIAL
  • ndc11
    0407069015
    10 VIAL in 1 BOX (0407-0690-15) / 15 mL in 1 VIAL
  • ndc11
    0407069020
    10 VIAL in 1 BOX (0407-0690-20) / 20 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
84F6U3J2R6
GADODIAMIDE
RxCUI 41144
Orange Book
N020123
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "84F6U3J2R6",
    "rxcui": "41144",
    "inchikey": "HZHFFEYYPYZMNU-UHFFFAOYSA-K",
    "display_name": "GADODIAMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "1e9a37e2-f28a-4373-bf0f-3e9b60f42d8a": {
      "match": "brand_token",
      "title": "OMNISCAN (GADODIAMIDE) INJECTION [GE HEALTHCARE INC.]",
      "spl_version": "24",
      "published_date": "2025-04-28"
    }
  },
  "productid": "0407-0690_dfe2f58c-7a8f-408a-9690-6300a49eda17",
  "productndc": "0407-0690",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "020123",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "287MG/ML",
        "product_no": "001",
        "approval_date": "Jan 8, 1993"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GADODIAMIDE",
  "proprietary_name": "OMNISCAN",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA020123",
  "marketing_category": "NDA",
  "nonproprietary_name": "gadodiamide",
  "start_marketing_date": "20020419",
  "active_numerator_strength": "287"
}

Related drugs

Other records sharing ATC code V08CA03.

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