What is NDC 65219-383?

65219-383 is the product NDC for Iodixanol, Iodixanol 320 mg/mL injection, solution, listed with the FDA by FRESENIUS KABI USA, LLC. It has 4 package NDCs, 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 Iodixanol?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Iodixanol NDC 65219-383 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65219-383Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65219-0383Add 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
65219-383-05	65219038305	10 BOTTLE, PLASTIC in 1 BOX (65219-383-05) / 50 mL in 1 BOTTLE, PLASTIC (65219-383-02)Marketed from Jun 21, 2022
65219-383-10	65219038310	10 BOTTLE, PLASTIC in 1 BOX (65219-383-10) / 100 mL in 1 BOTTLE, PLASTIC (65219-383-04)Marketed from Jun 21, 2022
65219-383-50	65219038350	10 BOTTLE, PLASTIC in 1 BOX (65219-383-50) / 150 mL in 1 BOTTLE, PLASTIC (65219-383-06)Marketed from Jun 21, 2022
65219-383-70	65219038370	10 BOTTLE, PLASTIC in 1 BOX (65219-383-70) / 200 mL in 1 BOTTLE, PLASTIC (65219-383-08)Marketed from Jun 21, 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): Iodixanol
Generic name (nonproprietary): iodixanol
Active ingredients: Iodixanol — 320 mg/mL
Dosage form: Injection, Solution
Route: Intravascular
Labeler: FRESENIUS KABI USA, LLCNDC labeler code 65219
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214271
Marketing start: Jun 21, 2022
Listing expires: Dec 31, 2026
Other FDA classes: X-Ray Contrast Activity (Mechanism)
Identifiers: Product ID 65219-383_1980ecbd-58c9-4176-af7f-af955bb0ad2eSPL ID 1980ecbd-58c9-4176-af7f-af955bb0ad2eSPL set ID 0fe89ea2-04f7-46c5-9c35-220d8c144a95UNII HW8W27HTXX
Pharmacologic class: Radiographic 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.

NDC on a medical claim

N465219038305 followed by a unit qualifier and the quantity

Package 65219-0383-05. 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 Jul 21, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Iodixanol injection is indicated in for: Iodixanol injection is a radiographic contrast agent indicated for the following: Intra-arterial Procedures ( 1.1 ) Adults and pediatric patients 12 years of age and over Intra-arterial digital subtraction angiography (270 mg Iodine/mL and 320 mg Iodine/mL). Angiocardiography (left ventriculography and selective coronary arteriography), peripheral arteriography, visceral arteriography, and cerebral arteriography (320 mg Iodine/mL). Pediatric patients less than 12 years of age Angiocardiography, cerebral arteriography, and visceral arteriography (320 mg Iodine/mL). Intravenous Procedures ( 1.2 ) Adults and pediatric patients 12 years of age and over Co…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65219-383

What is NDC 65219-383?: 65219-383 is the product NDC for Iodixanol, Iodixanol 320 mg/mL injection, solution, 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?: Iodixanol.
What is the active ingredient?: Iodixanol.
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 Iodixanol?: 1 other product NDC are listed under this name. See all Iodixanol 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 Iodixanol NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Iodixanol	Iodixanol 270 mg/mL	Injection, SolutionIntravascular	FRESENIUS KABI USA, LLC	65219-381	65219-0381-1065219-0381-50

Other NDCs under ANDA 214271

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

FDA NDC Directory listings under ANDA 214271
Product	Strength	Form · route	Labeler	Product NDC
Iodixanol	Iodixanol 270 mg/mL	Injection, SolutionIntravascular	FRESENIUS KABI USA, LLC	65219-381