ELUCIREM

Orange BookUNIISPLATC V08CA12

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerGuerbet LLC

CountryUS (United States)

ATC codeV08CA12

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6768442421
1 SYRINGE in 1 CARTON (67684-4242-1) / 15 mL in 1 SYRINGE
ndc11
6768442422
10 SYRINGE in 1 CARTON (67684-4242-2) / 15 mL in 1 SYRINGE

Annotations

UNII (FDA Substance ID)

S276568KOY

GADOPICLENOL

RxCUI 2618720

Orange Book

N216986

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "S276568KOY",
    "rxcui": "2618720",
    "inchikey": "GNRQMLROZPOLDG-UHFFFAOYSA-K",
    "display_name": "GADOPICLENOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "ca582f31-1042-487f-82e4-533f1b541902": {
      "match": "brand_token",
      "title": "ELUCIREM (GADOPICLENOL) INJECTION [GUERBET LLC]",
      "spl_version": "13",
      "published_date": "2026-03-12"
    }
  },
  "productid": "67684-4242_e15d694f-7809-4715-a8c8-a432c05760cc",
  "productndc": "67684-4242",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "216986",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1.4553GM/3ML (485.1MG/ML)",
        "product_no": "001",
        "approval_date": "Sep 21, 2022"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "3.63825GM/7.5ML (485.1MG/ML)",
        "product_no": "002",
        "approval_date": "Sep 21, 2022"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "4.851GM/10ML (485.1MG/ML)",
        "product_no": "003",
        "approval_date": "Sep 21, 2022"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "7.2765GM/15ML (485.1MG/ML)",
        "product_no": "004",
        "approval_date": "Sep 21, 2022"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "14.553GM/30ML (485.1MG/ML)",
        "product_no": "005",
        "approval_date": "Sep 21, 2022"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "24.255GM/50ML (485.1MG/ML)",
        "product_no": "006",
        "approval_date": "Sep 21, 2022"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "48.51GM/100ML (485.1MG/ML)",
        "product_no": "007",
        "approval_date": "Sep 21, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GADOPICLENOL",
  "proprietary_name": "ELUCIREM",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA216986",
  "marketing_category": "NDA",
  "nonproprietary_name": "gadopiclenol",
  "start_marketing_date": "20220921",
  "active_numerator_strength": "485.1"
}

Related drugs

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