Lacosamide NDC 69543-455

NDC codes

FDA NDC Directory

Product NDC (as listed)69543-455Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69543-0455Add 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
69543-455-10	69543045510	10 VIAL, GLASS in 1 CARTON (69543-455-10) / 20 mL in 1 VIAL, GLASS (69543-455-20)Marketed from Apr 17, 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): Lacosamide
Generic name (nonproprietary): lacosamide
Active ingredients: Lacosamide — 10 mg/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Virtus Pharmaceuticals, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215628
Marketing start: Apr 17, 2023
Marketing end: Sep 30, 2027
DEA schedule: CV
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 69543-455_21cd2911-f9de-4d64-b2b3-409a8eb01b8dSPL ID 21cd2911-f9de-4d64-b2b3-409a8eb01b8dSPL set ID 01162e2f-967b-4596-8188-c0d9889c3814RxCUI 809974UNII 563KS2PQY5

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

N469543045510 followed by a unit qualifier and the quantity

Package 69543-0455-10. 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 Jan 23, 2026.

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 pediatric information.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 215628

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

FDA NDC Directory listings under ANDA 215628
Product	Strength	Form · route	Labeler	Product NDC
Lacosamide	Lacosamide 10 mg/mL	InjectionIntravenous	Fosun Pharma USA	72266-242
Lacosamide	Lacosamide 10 mg/mL	InjectionIntravenous	Gland Pharma Limited	68083-480