Clariscan (gadoterate meglumine) NDC 0407-2943

NDC codes

FDA NDC Directory

Product NDC (as listed)0407-2943Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00407-2943Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0407-2943-70	00407294370	10 BOTTLE, PLASTIC in 1 BOX (0407-2943-70) / 100 mL in 1 BOTTLE, PLASTICMarketed from Aug 4, 2020

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Clariscan
Generic name (nonproprietary): gadoterate meglumine
Active ingredients: Gadoterate meglumine — 376.9 mg/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: GE Healthcare
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210016
Marketing start: Nov 1, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Magnetic Resonance Contrast Activity (Mechanism)
Identifiers: Product ID 0407-2943_03f42c78-1d36-46fd-b570-042571e5912eSPL ID 03f42c78-1d36-46fd-b570-042571e5912eSPL set ID c9e273b3-481f-4899-8913-95aaddcc7662UNII L0ND3981AG
Pharmacologic class: Gadolinium-based Contrast Agent

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N400407294370 followed by a unit qualifier and the quantity

Package 00407-2943-70. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Apr 30, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Clariscan is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity. Clariscan is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)