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
6768442501
1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-1) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE
ndc11
6768442502
25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-2) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE
ndc11
6768442503
1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-3) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE
ndc11
6768442504
25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-4) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE
ndc11
6768442505
1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-5) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE
ndc11
6768442506
6 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-6) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE
ndc11
6768442507
12 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-7) / 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": "67684-4250_e15d694f-7809-4715-a8c8-a432c05760cc",
  "productndc": "67684-4250",
  "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"
}

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