Prescription drug · ANDA
Gadoterate Meglumine NDC 65219-086
Gadoterate meglumine 376.9 mg/mL · Injection · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65219-086-20 | 65219008620 | 10 CARTON in 1 BOX (65219-086-20) / 1 VIAL in 1 CARTON (65219-086-01) / 20 mL in 1 VIALMarketed from Jun 20, 2022 |
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)
- Gadoterate Meglumine
- Generic name (nonproprietary)
- gadoterate meglumine
- Active ingredients
- Gadoterate meglumine — 376.9 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Fresenius Kabi USA, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215304
- Marketing start
- Listing expires
- Other FDA classes
- Magnetic Resonance Contrast Activity (Mechanism)
- Identifiers
- Product ID 65219-086_f05922b7-99d4-48c7-972a-7966bbbbc3b4SPL ID f05922b7-99d4-48c7-972a-7966bbbbc3b4SPL set ID e0655aac-9508-4141-94f5-fcca6af1c41dUNII L0ND3981AGUPC 0365219086017, 0365219084013, 0365219080015, 0365219082019
- 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
N465219008620followed by a unit qualifier and the quantityPackage 65219-0086-20. 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)
Gadoterate Meglumine Injection 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. Gadoterate Meglumine Injection 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 …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 215304
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Gadoterate Meglumine | Gadoterate meglumine 376.9 mg/mL | InjectionIntravenous | Fresenius Kabi USA, LLC | 65219-082 |
| Gadoterate Meglumine | Gadoterate meglumine 376.9 mg/mL | InjectionIntravenous | Fresenius Kabi USA, LLC | 65219-080 |
| Gadoterate Meglumine | Gadoterate meglumine 376.9 mg/mL | InjectionIntravenous | Fresenius Kabi USA, LLC | 65219-084 |