What is NDC 69315-318?

69315-318 is the product NDC for Lacosamide, Lacosamide 10 mg/mL solution, listed with the FDA by Leading Pharma, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Leading Pharma, LLC, NDC labeler code 69315. 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 69315-318 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69315-318Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69315-0318Add 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
69315-318-20	6931503182069315031820	200 mL in 1 BOTTLE, PLASTIC (69315-318-20)Marketed from Jul 25, 2023
69315-318-46	6931503184669315031846	465 mL in 1 BOTTLE, PLASTIC (69315-318-46)Marketed from Jul 25, 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: Solution
Route: Oral
Labeler: Leading Pharma, LLCNDC labeler code 69315
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216461
Marketing start: Feb 6, 2023
Listing expires: Dec 31, 2026
DEA schedule: CV
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 69315-318_0267a67e-d492-480b-a688-e2cec27142a6SPL ID 0267a67e-d492-480b-a688-e2cec27142a6SPL set ID 45786c84-51ef-4440-bc88-2501951e4c41RxCUI 993856UNII 563KS2PQY5UPC 0369315318461

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

N469315031820 followed by a unit qualifier and the quantity

Package 69315-0318-20. 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 Dec 6, 2024.

Indications (excerpt from the label)

Lacosamide oral solution 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 oral solution is indicated for the treatment of partial-onset seizures in patients 4 years 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. Additional pediatric use information is approved for UCB, Inc.’s VIMPAT ® (lacosamide) oral solut…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69315-318

What is NDC 69315-318?: 69315-318 is the product NDC for Lacosamide, Lacosamide 10 mg/mL solution, listed with the FDA by Leading Pharma, LLC. It has 2 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?: Leading Pharma, LLC, NDC labeler code 69315. 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 216461

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

FDA NDC Directory listings under ANDA 216461
Product	Strength	Form · route	Labeler	Product NDC
Lacosamide	Lacosamide 50 mg/5mL	SolutionOral	Precision Dose, Inc.	68094-076
Lacosamide	Lacosamide 100 mg/10mL	SolutionOral	Precision Dose, Inc.	68094-176
Lacosamide	Lacosamide 10 mg/mL	SolutionOral	Kanchan Healthcare Inc	85742-014