gadobutrol NDC 70436-214

NDC codes

FDA NDC Directory

Product NDC (as listed)70436-214Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70436-0214Add 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
70436-214-54	70436021454	20 VIAL, SINGLE-DOSE in 1 CARTON (70436-214-54) / 15 mL in 1 VIAL, SINGLE-DOSE (70436-214-34)Marketed from Oct 20, 2023
70436-214-80	70436021480	1 VIAL, SINGLE-DOSE in 1 CARTON (70436-214-80) / 15 mL in 1 VIAL, SINGLE-DOSE (70436-214-34)Marketed from Oct 20, 2023

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): gadobutrol
Generic name (nonproprietary): gadobutrol
Active ingredients: Gadobutrol — 604.72 mg/mL
Dosage form: Injection
Route: Intravenous
Labeler: Slate Run Pharmaceuticals, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217480
Marketing start: Oct 20, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Magnetic Resonance Contrast Activity (Mechanism)
Identifiers: Product ID 70436-214_3304f07e-e137-e806-e063-6394a90a8a4aSPL ID 3304f07e-e137-e806-e063-6394a90a8a4aSPL set ID 832e0ae1-4fe1-4dff-9978-c9200bcebb55UNII 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

N470436021454 followed by a unit qualifier and the quantity

Package 70436-0214-54. 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 17, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Gadobutrol injection is a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI): To detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system in adult and pediatric patients, including term neonates ( 1.1 ) To assess the presence and extent of malignant breast disease in adult patients ( 1.2 ) To evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients, including term neonates ( 1.3 ) To assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD) ( 1.4 ) 1.1 Magnetic Reson…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 217480

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 217480
Product	Strength	Form · route	Labeler	Product NDC
gadobutrol	Gadobutrol 604.72 mg/mL	InjectionIntravenous	Slate Run Pharmaceuticals, LLC	70436-216
gadobutrol	Gadobutrol 604.72 mg/mL	InjectionIntravenous	Slate Run Pharmaceuticals, LLC	70436-212
gadobutrol	Gadobutrol 604.72 mg/mL	InjectionIntravenous	Slate Run Pharmaceuticals, LLC	70436-213
gadobutrol	Gadobutrol 604.72 mg/mL	InjectionIntravenous	Slate Run Pharmaceuticals, LLC	70436-218
gadobutrol	Gadobutrol 604.72 mg/mL	InjectionIntravenous	Slate Run Pharmaceuticals, LLC	70436-216
gadobutrol	Gadobutrol 604.72 mg/mL	InjectionIntravenous	Slate Run Pharmaceuticals, LLC	70436-217
gadobutrol	Gadobutrol 604.72 mg/mL	InjectionIntravenous	Slate Run Pharmaceuticals, LLC	70436-217