What is NDC 83090-012?

83090-012 is the product NDC for Lacosamide, Lacosamide 10 mg/mL injection, listed with the FDA by Sintetica US LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Sintetica US LLC, NDC labeler code 83090. 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 83090-012 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)83090-012Labeler and product segments. Claims need a package NDC.

Product NDC at billing width83090-0012Add 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
83090-012-10	8309000121083090001210	10 VIAL, GLASS in 1 CARTON (83090-012-10) / 20 mL in 1 VIAL, GLASSMarketed from Mar 15, 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: Injection
Route: Intravenous
Labeler: Sintetica US LLCNDC labeler code 83090
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217311
Marketing start: Mar 15, 2024
Listing expires: Dec 31, 2027
DEA schedule: CV
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 83090-012_d122b8ed-0688-4516-92a2-4b1fa1e7fa99SPL ID d122b8ed-0688-4516-92a2-4b1fa1e7fa99SPL set ID 08ac486a-4f61-4e9e-9683-d1a66a6c2a4dRxCUI 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

N483090001210 followed by a unit qualifier and the quantity

Package 83090-0012-10. 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 4, 2026.

Indications (excerpt from the label)

Lacosamide Injection 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 Injection is indicated for the treatment of partial-onset seizures in patients 4 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 information. 1.2 Primary Generalized Tonic-Clonic Seizures Lacosamide Injection is indicated as adjunctive therapy in the trea…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 83090-012

What is NDC 83090-012?: 83090-012 is the product NDC for Lacosamide, Lacosamide 10 mg/mL injection, listed with the FDA by Sintetica US LLC. It has 1 package NDC, 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?: Sintetica US LLC, NDC labeler code 83090. 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