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United States · US · US:70436-121_3f886711-cb41-3241-e063-6394a90a5bc7

GADOTERIDOL

Orange BookUNIISPLATC V08CA04

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

Identification

ManufacturerSlate Run Pharmaceuticals, LLC
CountryUS (United States)
ATC codeV08CA04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    7043612131
    5 VIAL, SINGLE-DOSE in 1 CARTON (70436-121-31) / 5 mL in 1 VIAL, SINGLE-DOSE
  • ndc11
    7043612133
    5 VIAL, SINGLE-DOSE in 1 CARTON (70436-121-33) / 10 mL in 1 VIAL, SINGLE-DOSE
  • ndc11
    7043612134
    5 VIAL, SINGLE-DOSE in 1 CARTON (70436-121-34) / 15 mL in 1 VIAL, SINGLE-DOSE
  • ndc11
    7043612135
    5 VIAL, SINGLE-DOSE in 1 CARTON (70436-121-35) / 20 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
0199MV609F
GADOTERIDOL
RxCUI 25483
Orange Book
A218749
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "0199MV609F",
    "rxcui": "25483",
    "inchikey": "DPNNNPAKRZOSMO-UHFFFAOYSA-K",
    "display_name": "GADOTERIDOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "538a70e0-061c-40d2-8447-5b7a4e61a55f": {
      "match": "brand_token",
      "title": "GADOTERIDOL INJECTION [SLATE RUN PHARMACEUTICALS, LLC]",
      "spl_version": "2",
      "published_date": "2025-09-29"
    }
  },
  "productid": "70436-121_3f886711-cb41-3241-e063-6394a90a5bc7",
  "productndc": "70436-121",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "218749",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "279.3MG/ML",
        "product_no": "001",
        "approval_date": "Feb 11, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GADOTERIDOL",
  "proprietary_name": "GADOTERIDOL",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA218749",
  "marketing_category": "ANDA",
  "nonproprietary_name": "GADOTERIDOL",
  "start_marketing_date": "20250220",
  "active_numerator_strength": "279.3"
}

Related drugs

Other records sharing ATC code V08CA04.

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