Lacosamide NDC 29300-365

NDC codes

FDA NDC Directory

Product NDC (as listed)29300-365Labeler and product segments. Claims need a package NDC.

Product NDC at billing width29300-0365Add 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
29300-365-05	29300036505	500 TABLET, FILM COATED in 1 BOTTLE (29300-365-05)Marketed from Dec 1, 2024
29300-365-16	29300036516	60 TABLET, FILM COATED in 1 BOTTLE (29300-365-16)Marketed from Dec 1, 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 — 100 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Unichem Pharmaceuticals (USA), Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213109
Marketing start: Dec 1, 2024
Listing expires: Dec 31, 2026
DEA schedule: CV
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 29300-365_d452fee5-4940-4740-8c4d-8024788eafc6SPL ID d452fee5-4940-4740-8c4d-8024788eafc6SPL set ID 7ed5cebe-470e-48a4-86ec-2ce79cc32688RxCUI 809987, 809992, 809996, 810000UNII 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

N429300036505 followed by a unit qualifier and the quantity

Package 29300-0365-05. 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 Sep 17, 2024.

Indications (excerpt from the label)

Lacosamide tablet is indicated for: Treatment of partial-onset seizures in patients 4 years 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 tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older. Additional pediatric use information is approved for UCB, Inc.'s VIMPAT ® (lacosamide) tablets. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information. 1.2 Primary Generalized Tonic-Clonic Seizures Lacosamide tablets are indicated as adjunctive therapy in t…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 213109

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

FDA NDC Directory listings under ANDA 213109
Product	Strength	Form · route	Labeler	Product NDC
Lacosamide	Lacosamide 50 mg/1	Tablet, Film coatedOral	Unichem Pharmaceuticals (USA), Inc.	29300-364
Lacosamide	Lacosamide 150 mg/1	Tablet, Film coatedOral	Unichem Pharmaceuticals (USA), Inc.	29300-366
Lacosamide	Lacosamide 200 mg/1	Tablet, Film coatedOral	Unichem Pharmaceuticals (USA), Inc.	29300-367