What is NDC 65219-088?

65219-088 is the product NDC for Gadoterate Meglumine, Gadoterate meglumine 376.9 mg/mL injection, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

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 Gadoterate Meglumine?

5 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Gadoterate Meglumine NDC 65219-088

NDC codes

FDA NDC Directory

Product NDC (as listed)65219-088Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65219-0088Add 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
65219-088-50	6521900885065219008850	6 CARTON in 1 BOX (65219-088-50) / 1 VIAL in 1 CARTON (65219-088-06) / 100 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, LLCNDC labeler code 65219
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215982
Marketing start: Jun 20, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Magnetic Resonance Contrast Activity (Mechanism)
Identifiers: Product ID 65219-088_8b9a98ef-bee6-43fc-a39d-2e5a3c226653SPL ID 8b9a98ef-bee6-43fc-a39d-2e5a3c226653SPL set ID fbebe7f2-a0c2-4fd5-b421-8fbcbaf46709UNII L0ND3981AGUPC 0365219088066
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

N465219008850 followed by a unit qualifier and the quantity

Package 65219-0088-50. 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 Nov 7, 2025. 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 v…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65219-088

What is NDC 65219-088?: 65219-088 is the product NDC for Gadoterate Meglumine, Gadoterate meglumine 376.9 mg/mL injection, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Gadoterate Meglumine.
What is the active ingredient?: Gadoterate meglumine.
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 Gadoterate Meglumine?: 5 other product NDCs are listed under this name. See all Gadoterate Meglumine NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Gadoterate Meglumine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
gadoterate meglumine	Gadoterate meglumine 376.9 mg/mL	InjectionIntravenous	Slate Run Pharmaceuticals, LLC	70436-123	70436-0123-3170436-0123-3370436-0123-34+1 more
Gadoterate Meglumine	Gadoterate meglumine 376.9 mg/mL	InjectionIntravenous	Fresenius Kabi USA, LLC	65219-080	65219-0080-05
Gadoterate Meglumine	Gadoterate meglumine 376.9 mg/mL	InjectionIntravenous	Fresenius Kabi USA, LLC	65219-082	65219-0082-10
Gadoterate Meglumine	Gadoterate meglumine 376.9 mg/mL	InjectionIntravenous	Fresenius Kabi USA, LLC	65219-084	65219-0084-15
Gadoterate Meglumine	Gadoterate meglumine 376.9 mg/mL	InjectionIntravenous	Fresenius Kabi USA, LLC	65219-086	65219-0086-20