What is NDC 50419-325?

50419-325 is the product NDC for Gadavist (gadobutrol), Gadobutrol 604.72 mg/mL injection, listed with the FDA by Bayer HealthCare Pharmaceuticals Inc..

Bayer HealthCare Pharmaceuticals Inc., NDC labeler code 50419. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Gadavist?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Gadavist NDC 50419-325 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)50419-325Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50419-0325Add the package segment from the table below.

Product information

Brand name (proprietary): Gadavist
Generic name (nonproprietary): gadobutrol
Active ingredients: Gadobutrol — 604.72 mg/mL
Dosage form: Injection
Route: Intravenous
Labeler: Bayer HealthCare Pharmaceuticals Inc.NDC labeler code 50419
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 201277
Marketing start: Mar 14, 2011
Listing expires: Dec 31, 2027
Other FDA classes: Magnetic Resonance Contrast Activity (Mechanism)
Identifiers: Product ID 50419-325_d83d6225-65ea-436f-aba2-d83d748c8fdeSPL ID d83d6225-65ea-436f-aba2-d83d748c8fdeSPL set ID bd28560f-de4d-4140-874e-31df823f4dbbUNII 1BJ477IO2L
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

Product label

Current FDA label (SPL), effective May 1, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

GADAVIST is indicated for: Magnetic resonance imaging (MRI) of the central nervous system (CNS) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity in adult and pediatric patients including term neonates MRI of the breast to assess the presence and extent of malignant breast disease in adult patients Magnetic resonance angiography (MRA) to evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients including term neonates Cardiac MRI (CMRI) to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD) GADAVIST is a gadolinium-ba…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50419-325

What is NDC 50419-325?: 50419-325 is the product NDC for Gadavist (gadobutrol), Gadobutrol 604.72 mg/mL injection, listed with the FDA by Bayer HealthCare Pharmaceuticals Inc..
What drug is associated with this NDC?: Gadavist (Gadobutrol).
What is the active ingredient?: Gadobutrol.
Who is the labeler?: Bayer HealthCare Pharmaceuticals Inc., NDC labeler code 50419. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Gadavist?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Gadavist (Gadobutrol) NDC 50419-325