elucirem

Generic: gadopiclenol

Labeler: guerbet llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name elucirem
Generic Name gadopiclenol
Labeler guerbet llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

gadopiclenol 485.1 mg/mL

Manufacturer
Guerbet LLC

Identifiers & Regulatory

Product NDC 67684-4250
Product ID 67684-4250_e15d694f-7809-4715-a8c8-a432c05760cc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA216986
Listing Expiration 2027-12-31
Marketing Start 2022-09-21

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 676844250
Hyphenated Format 67684-4250

Supplemental Identifiers

UPC
0367684424028 0367684423120
UNII
S276568KOY

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name elucirem (source: ndc)
Generic Name gadopiclenol (source: ndc)
Application Number NDA216986 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 485.1 mg/mL
source: ndc
Packaging
  • 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-1) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE
  • 25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-2) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE
  • 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-3) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE
  • 25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-4) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE
  • 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-5) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE
  • 6 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-6) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE
  • 12 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-7) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE
source: ndc

Packages (7)

67684-4250-1 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-1) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE 67684-4250-2 25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-2) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE 67684-4250-3 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-3) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE 67684-4250-4 25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-4) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE 67684-4250-5 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-5) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE 67684-4250-6 6 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-6) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE 67684-4250-7 12 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-7) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE

Ingredients (1)

gadopiclenol (485.1 mg/mL)

Linked Drug Pages (1)

ELUCIREM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "e15d694f-7809-4715-a8c8-a432c05760cc", "openfda": {"upc": ["0367684424028", "0367684423120"], "unii": ["S276568KOY"], "spl_set_id": ["ca582f31-1042-487f-82e4-533f1b541902"], "manufacturer_name": ["Guerbet LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-1)  / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE", "package_ndc": "67684-4250-1", "marketing_start_date": "20220921"}, {"sample": false, "description": "25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-2)  / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE", "package_ndc": "67684-4250-2", "marketing_start_date": "20220921"}, {"sample": false, "description": "1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-3)  / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE", "package_ndc": "67684-4250-3", "marketing_start_date": "20220921"}, {"sample": false, "description": "25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-4)  / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE", "package_ndc": "67684-4250-4", "marketing_start_date": "20220921"}, {"sample": false, "description": "1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-5)  / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE", "package_ndc": "67684-4250-5", "marketing_start_date": "20220921"}, {"sample": false, "description": "6 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-6)  / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE", "package_ndc": "67684-4250-6", "marketing_start_date": "20220921"}, {"sample": false, "description": "12 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-7)  / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE", "package_ndc": "67684-4250-7", "marketing_start_date": "20220921"}], "brand_name": "ELUCIREM", "product_id": "67684-4250_e15d694f-7809-4715-a8c8-a432c05760cc", "dosage_form": "INJECTION", "product_ndc": "67684-4250", "generic_name": "gadopiclenol", "labeler_name": "Guerbet LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ELUCIREM", "active_ingredients": [{"name": "GADOPICLENOL", "strength": "485.1 mg/mL"}], "application_number": "NDA216986", "marketing_category": "NDA", "marketing_start_date": "20220921", "listing_expiration_date": "20271231"}