Prescription drug · ANDA

Lacosamide NDC 50228-194

Lacosamide 150 mg/1 · Tablet, Film coated · Oral · ScieGen Pharmaceuticals Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)50228-194Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50228-0194Add 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 NDC11-digit (billing)PackageCopy
50228-194-10502280194101000 TABLET, FILM COATED in 1 BOTTLE (50228-194-10)Marketed from Mar 18, 2022
50228-194-305022801943030 TABLET, FILM COATED in 1 BOTTLE (50228-194-30)Marketed from Mar 18, 2022
50228-194-605022801946060 TABLET, FILM COATED in 1 BOTTLE (50228-194-60)Marketed from Mar 18, 2022

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 — 150 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205237
Marketing start
Listing expires
DEA schedule
CV
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 50228-194_56788345-3f8e-478c-b73d-216b4d711b57SPL ID 56788345-3f8e-478c-b73d-216b4d711b57SPL set ID f4ffa3ad-1278-4772-9ef8-ed6fdaa47605RxCUI 809987, 809992, 809996, 810000UNII 563KS2PQY5UPC 0350228195607, 0350228193603, 0350228194600, 0350228192606

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

N450228019410 followed by a unit qualifier and the quantity

Package 50228-0194-10. 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 .

Indications (excerpt from the label)

​ Lacosamide 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 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 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 205237

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

FDA NDC Directory listings under ANDA 205237
ProductStrengthForm · routeLabelerProduct NDC
LacosamideLacosamide 200 mg/1Tablet, Film coatedOralWestminster Pharmaceuticals, LLC69367-351
LacosamideLacosamide 50 mg/1Tablet, Film coatedOralWestminster Pharmaceuticals, LLC69367-348
LacosamideLacosamide 100 mg/1Tablet, Film coatedOralWestminster Pharmaceuticals, LLC69367-349
LacosamideLacosamide 150 mg/1Tablet, Film coatedOralWestminster Pharmaceuticals, LLC69367-350
LacosamideLacosamide 200 mg/1Tablet, Film coatedOralProficient Rx LP82804-993
LacosamideLacosamide 50 mg/1Tablet, Film coatedOralProficient Rx LP82804-990
LacosamideLacosamide 100 mg/1Tablet, Film coatedOralProficient Rx LP82804-991
LacosamideLacosamide 150 mg/1Tablet, Film coatedOralProficient Rx LP82804-992
LacosamideLacosamide 50 mg/1Tablet, Film coatedOralScieGen Pharmaceuticals Inc50228-192
LacosamideLacosamide 100 mg/1Tablet, Film coatedOralScieGen Pharmaceuticals Inc50228-193
LacosamideLacosamide 200 mg/1Tablet, Film coatedOralScieGen Pharmaceuticals Inc50228-195
LacosamideLacosamide 100 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4562

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Lacosamide NDC 50228-194 | Med-Code