Lacosamide NDC 59651-016

NDC codes

FDA NDC Directory

Product NDC (as listed)59651-016Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59651-0016Add 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
59651-016-02	59651001602	200 mL in 1 BOTTLE, PLASTIC (59651-016-02)Marketed from Jan 24, 2024
59651-016-46	59651001646	465 mL in 1 BOTTLE, PLASTIC (59651-016-46)Marketed from Jan 24, 2024

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: Solution
Route: Oral
Labeler: Aurobindo Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209224
Marketing start: Jan 24, 2024
Listing expires: Dec 31, 2027
DEA schedule: CV
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 59651-016_020fa65d-ecba-4477-9b27-ca951a117900SPL ID 020fa65d-ecba-4477-9b27-ca951a117900SPL set ID 614490ce-a62c-4222-8e4b-ce802cf63028RxCUI 993856UNII 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N459651001602 followed by a unit qualifier and the quantity

Package 59651-0016-02. 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 Jun 22, 2026.

Indications (excerpt from the label)

Lacosamide oral solution is indicated for: Treatment of partial-onset seizures in patients 1 month of age and older ( 1.1 ) Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older ( 1.2 ) 1.1 Partial-Onset Seizures Lacosamide oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. 1.2 Primary Generalized Tonic-Clonic Seizures Lacosamide oral solution is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 209224

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

FDA NDC Directory listings under ANDA 209224
Product	Strength	Form · route	Labeler	Product NDC
Lacosamide	Lacosamide 10 mg/mL	SolutionOral	American Health Packaging	60687-847
Lacosamide	Lacosamide 10 mg/mL	SolutionOral	NorthStar Rx LLC	72603-305