What is NDC 80425-0510?

80425-0510 is the product NDC for Lacosamide, Lacosamide 50 mg/1 tablet, film coated, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

Advanced Rx of Tennessee, LLC, NDC labeler code 80425. 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?

146 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 80425-0510 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0510Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0510Add 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
80425-0510-1	8042505100180425051001	30 TABLET, FILM COATED in 1 BOTTLE (80425-0510-1)Marketed from Apr 9, 2025
80425-0510-2	8042505100280425051002	60 TABLET, FILM COATED in 1 BOTTLE (80425-0510-2)Marketed from Apr 9, 2025
80425-0510-3	8042505100380425051003	90 TABLET, FILM COATED in 1 BOTTLE (80425-0510-3)Marketed from Apr 9, 2025

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 50 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Advanced Rx of Tennessee, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214695
Marketing start: Apr 9, 2025
Listing expires: Dec 31, 2026
DEA schedule: CV
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 80425-0510_325df1f8-167c-c07c-e063-6294a90a96fbSPL ID 325df1f8-167c-c07c-e063-6294a90a96fbSPL set ID 325df1b7-4908-0c03-e063-6294a90ad844RxCUI 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

N480425051001 followed by a unit qualifier and the quantity

Package 80425-0510-01. 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 Apr 9, 2025.

Indications (excerpt from the label)

Lacosamide tablets are 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. 1.2 Primary Generalized Tonic-Clonic Seizures Lacosamide tablets are indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older. Additional pediatric use information is approved for UCB, Inc.'s VIMPAT ® (lacosamide) tablets. However, due t…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0510

What is NDC 80425-0510?: 80425-0510 is the product NDC for Lacosamide, Lacosamide 50 mg/1 tablet, film coated, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 3 package NDCs, 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?: Advanced Rx of Tennessee, LLC, NDC labeler code 80425. 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?: 146 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	TabletOral	AvPAK	50268-491	50268-0491-10
Lacosamide	Lacosamide 100 mg/1	TabletOral	AvPAK	50268-492	50268-0492-10
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.	70518-4562	70518-4562-00
Lacosamide	Lacosamide 100 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4561	70518-4561-0070518-4561-02
Lacosamide	Lacosamide 10 mg/mL	Injection, SolutionIntravenous	Anthea Pharma Private Limited	83854-002	83854-0002-10
Lacosamide	Lacosamide 50 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4503	70518-4503-00
Lacosamide	Lacosamide 200 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4504	70518-4504-0070518-4504-0170518-4504-03
Lacosamide	Lacosamide 100 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4505	70518-4505-00

All 147 Lacosamide NDCs

Other NDCs under ANDA 214695

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

FDA NDC Directory listings under ANDA 214695
Product	Strength	Form · route	Labeler	Product NDC
Lacosamide	Lacosamide 50 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-7244
Lacosamide	Lacosamide 100 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-7245
Lacosamide	Lacosamide 150 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-7246
Lacosamide	Lacosamide 200 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-7247
Lacosamide	Lacosamide 50 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-676
Lacosamide	Lacosamide 100 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-687
Lacosamide	Lacosamide 200 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-698
Lacosamide	Lacosamide 50 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-733
Lacosamide	Lacosamide 100 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-734
Lacosamide	Lacosamide 150 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-735
Lacosamide	Lacosamide 200 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-736
Lacosamide	Lacosamide 100 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4561
Lacosamide	Lacosamide 50 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4689