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 · 7

ndc11
6768442511
1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4251-1) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE
ndc11
6768442512
25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4251-2) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE
ndc11
6768442513
1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4251-3) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE
ndc11
6768442514
25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4251-4) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE
ndc11
6768442515
1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4251-5) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE
ndc11
6768442516
6 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4251-6) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE
ndc11
6768442517
12 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4251-7) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE

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": "67684-4251_e15d694f-7809-4715-a8c8-a432c05760cc",
  "productndc": "67684-4251",
  "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": "20251114",
  "active_numerator_strength": "485.1"
}

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