Prescription drug · ANDA
Gadobutrol NDC 65219-281
Gadobutrol 604.72 mg/mL · Injection · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65219-281-02 | 65219028102 | 5 CARTON in 1 BOX (65219-281-02) / 3 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE (65219-281-00)Marketed from Apr 14, 2023 | |
| 65219-281-07 | 65219028107 | 2 CARTON in 1 BOX (65219-281-07) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 7.5 mL in 1 VIAL, SINGLE-DOSE (65219-281-03)Marketed from Apr 14, 2023 | |
| 65219-281-10 | 65219028110 | 2 CARTON in 1 BOX (65219-281-10) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE (65219-281-08)Marketed from Apr 14, 2023 | |
| 65219-281-15 | 65219028115 | 2 CARTON in 1 BOX (65219-281-15) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSE (65219-281-05)Marketed from Apr 14, 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
- Fresenius Kabi USA, LLCNDC labeler code 65219
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215061
- Marketing start
- Listing expires
- Other FDA classes
- Magnetic Resonance Contrast Activity (Mechanism)
- Identifiers
- Product ID 65219-281_490c8c3e-3195-40af-8f34-40d8df2719c3SPL ID 490c8c3e-3195-40af-8f34-40d8df2719c3SPL set ID 007696d0-4b62-4937-9640-4ad619504df4UNII 1BJ477IO2LUPC 0365219281023
- 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.
- NDC on a medical claim
N465219028102followed by a unit qualifier and the quantityPackage 65219-0281-02. 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 . 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 Magn…
Excerpt only. Read the full label for complete information.
About NDC 65219-281
- What is NDC 65219-281?
- 65219-281 is the product NDC for Gadobutrol, Gadobutrol 604.72 mg/mL injection, listed with the FDA by Fresenius Kabi USA, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Gadobutrol.
- What is the active ingredient?
- Gadobutrol.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 65219. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Gadobutrol?
- 16 other product NDCs are listed under this name. See all Gadobutrol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Gadobutrol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| gadobutrol | Gadobutrol 604.72 mg/mL | InjectionIntravenous | Zydus Pharmaceuticals USA Inc. | 70710-2065 | 70710-2065-06 |
| gadobutrol | Gadobutrol 604.72 mg/mL | InjectionIntravenous | Zydus Pharmaceuticals USA Inc. | 70710-2064 | 70710-2064-06 |
| gadobutrol | Gadobutrol 604.72 mg/mL | InjectionIntravenous | Zydus Pharmaceuticals USA Inc. | 70710-2066 | 70710-2066-06 |
| gadobutrol | Gadobutrol 604.72 mg/mL | InjectionIntravenous | Viwit Pharmaceutical Co., Ltd. | 42337-007 | 42337-0007-02 |
| gadobutrol | Gadobutrol 604.72 mg/mL | InjectionIntravenous | Viwit Pharmaceutical Co., Ltd. | 42337-005 | 42337-0005-02 |
| gadobutrol | Gadobutrol 604.72 mg/mL | InjectionIntravenous | Viwit Pharmaceutical Co., Ltd. | 42337-006 | 42337-0006-02 |
| gadobutrol | Gadobutrol 604.72 mg/mL | InjectionIntravenous | Slate Run Pharmaceuticals, LLC | 70436-213 | 70436-0213-82 |
| gadobutrol | Gadobutrol 604.72 mg/mL | InjectionIntravenous | Slate Run Pharmaceuticals, LLC | 70436-217 | 70436-0217-80 |
| gadobutrol | Gadobutrol 604.72 mg/mL | InjectionIntravenous | Slate Run Pharmaceuticals, LLC | 70436-218 | 70436-0218-84 |
| gadobutrol | Gadobutrol 604.72 mg/mL | InjectionIntravenous | Slate Run Pharmaceuticals, LLC | 70436-217 | 70436-0217-50 |