What is NDC 65219-204?

65219-204 is the product NDC for Lacosamide, Lacosamide 10 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 Lacosamide?

144 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Lacosamide NDC 65219-204 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65219-204Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65219-0204Add 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
65219-204-20	65219020420	10 VIAL, SINGLE-DOSE in 1 CARTON (65219-204-20) / 20 mL in 1 VIAL, SINGLE-DOSE (65219-204-01)Marketed from Jul 25, 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): Lacosamide
Generic name (nonproprietary): lacosamide
Active ingredients: Lacosamide — 10 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 214677
Marketing start: Jul 25, 2022
Listing expires: Dec 31, 2026
DEA schedule: CV
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 65219-204_0f09367f-3191-41f4-891c-abdd7ed3cecdSPL ID 0f09367f-3191-41f4-891c-abdd7ed3cecdSPL set ID 419ff519-2b19-4fb9-adfa-868ba0229407RxCUI 809974UNII 563KS2PQY5UPC 0365219204015

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

N465219020420 followed by a unit qualifier and the quantity

Package 65219-0204-20. 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 Feb 5, 2025.

Indications (excerpt from the label)

Lacosamide Injection is indicated for: • Treatment of partial-onset seizures in patients 17 years of age and older ( 1.1 ) 1.1 Partial-Onset Seizures Lacosamide Injection is indicated for the treatment of partial-onset seizures in patients 17 years of age and older. Pediatric use information is approved for UCB, Inc.'s VIMPAT ® (lacosamide) injection. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65219-204

What is NDC 65219-204?: 65219-204 is the product NDC for Lacosamide, Lacosamide 10 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?: Lacosamide.
What is the active ingredient?: Lacosamide.
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 Lacosamide?: 144 other product NDCs are listed under this name. See all Lacosamide 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 Lacosamide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Lacosamide	Lacosamide 50 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4689	70518-4689-0070518-4689-0270518-4689-03
Lacosamide	Lacosamide 10 mg/mL	Injection, SolutionIntravenous	GLENMARK PHARMACEUTICALS INC., USA	68462-697	68462-0697-30
Lacosamide	Lacosamide 100 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4561	70518-4561-0070518-4561-02
Lacosamide	Lacosamide 100 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4562	70518-4562-00
Lacosamide	Lacosamide 10 mg/mL	Injection, SolutionIntravenous	Anthea Pharma Private Limited	83854-002	83854-0002-10
Lacosamide	Lacosamide 200 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4504	70518-4504-0070518-4504-0170518-4504-03
Lacosamide	Lacosamide 50 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4503	70518-4503-00
Lacosamide	Lacosamide 100 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4505	70518-4505-00
Lacosamide	Lacosamide 50 mg/5mL	SolutionOral	Precision Dose, Inc.	68094-076	68094-0076-62
Lacosamide	Lacosamide 100 mg/10mL	SolutionOral	Precision Dose, Inc.	68094-176	68094-0176-62

All 145 Lacosamide NDCs