Gadavist (gadobutrol) NDC 50419-325

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.

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
50419-325-11	50419032511	2 CARTON in 1 BOX (50419-325-11) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 7.5 mL in 1 VIAL, SINGLE-DOSEMarketed from Mar 15, 2011
50419-325-12	50419032512	2 CARTON in 1 BOX (50419-325-12) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Mar 15, 2011
50419-325-13	50419032513	2 CARTON in 1 BOX (50419-325-13) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSEMarketed from Mar 15, 2011
50419-325-27	50419032527	5 SYRINGE, GLASS in 1 BOX (50419-325-27) / 7.5 mL in 1 SYRINGE, GLASSMarketed from Mar 15, 2011
50419-325-28	50419032528	5 SYRINGE, GLASS in 1 BOX (50419-325-28) / 10 mL in 1 SYRINGE, GLASSMarketed from Mar 15, 2011
50419-325-29	50419032529	5 SYRINGE, GLASS in 1 BOX (50419-325-29) / 15 mL in 1 SYRINGE, GLASSMarketed from Mar 15, 2011
50419-325-37	50419032537	15 CARTON in 1 BOX (50419-325-37) / 3 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSEMarketed from Mar 15, 2011
50419-325-72	50419032572	10 VIAL, SINGLE-DOSE in 1 CARTON (50419-325-72) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Mar 15, 2011 · Sample package
50419-325-75	50419032575	5 SYRINGE, GLASS in 1 BOX (50419-325-75) / 10 mL in 1 SYRINGE, GLASSMarketed from May 12, 2022 · Sample package

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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): Gadavist
Generic name (nonproprietary): gadobutrol
Active ingredients: Gadobutrol — 604.72 mg/mL
Dosage form: Injection
Route: Intravenous
Labeler: Bayer HealthCare Pharmaceuticals Inc.
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_67702ed5-ea44-4ed0-b65a-1d2a550ed3dbSPL ID 67702ed5-ea44-4ed0-b65a-1d2a550ed3dbSPL set ID 3c5101a0-0c7e-4078-8dc3-a57beb9a0e92UNII 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

NDC on a medical claim

N450419032511 followed by a unit qualifier and the quantity

Package 50419-0325-11. 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 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)