clariscan

Generic: gadoterate meglumine

Labeler: ge healthcare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clariscan
Generic Name gadoterate meglumine
Labeler ge healthcare
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

gadoterate meglumine 376.9 mg/mL

Manufacturer
GE Healthcare

Identifiers & Regulatory

Product NDC 0407-2943
Product ID 0407-2943_4c5494a9-1ff3-4f15-86c6-f84fe30632d4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210016
Listing Expiration 2026-12-31
Marketing Start 2019-11-01

Pharmacologic Class

Classes
gadolinium-based contrast agent [epc] magnetic resonance contrast activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04072943
Hyphenated Format 0407-2943

Supplemental Identifiers

UNII
L0ND3981AG

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 clariscan (source: ndc)
Generic Name gadoterate meglumine (source: ndc)
Application Number ANDA210016 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 376.9 mg/mL
source: ndc
Packaging
  • 10 BOTTLE, PLASTIC in 1 BOX (0407-2943-70) / 100 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

0407-2943-70 10 BOTTLE, PLASTIC in 1 BOX (0407-2943-70) / 100 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

gadoterate meglumine (376.9 mg/mL)

Linked Drug Pages (2)

CLARISCAN ndc-match (0.9) CLARISCAN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "4c5494a9-1ff3-4f15-86c6-f84fe30632d4", "openfda": {"unii": ["L0ND3981AG"], "spl_set_id": ["c9e273b3-481f-4899-8913-95aaddcc7662"], "manufacturer_name": ["GE Healthcare"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BOTTLE, PLASTIC in 1 BOX (0407-2943-70)  / 100 mL in 1 BOTTLE, PLASTIC", "package_ndc": "0407-2943-70", "marketing_start_date": "20200804"}], "brand_name": "CLARISCAN", "product_id": "0407-2943_4c5494a9-1ff3-4f15-86c6-f84fe30632d4", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Gadolinium-based Contrast Agent [EPC]", "Magnetic Resonance Contrast Activity [MoA]"], "product_ndc": "0407-2943", "generic_name": "gadoterate meglumine", "labeler_name": "GE Healthcare", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CLARISCAN", "active_ingredients": [{"name": "GADOTERATE MEGLUMINE", "strength": "376.9 mg/mL"}], "application_number": "ANDA210016", "marketing_category": "ANDA", "marketing_start_date": "20191101", "listing_expiration_date": "20261231"}