Prescription drug · ANDA

Lacosamide NDC 0121-1012

Lacosamide 50 mg/5mL · Solution · Oral · PAI Holdings, LLC dba PAI Pharma

NDC codes

FDA NDC Directory
Product NDC (as listed)0121-1012Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00121-1012Add 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
0121-1012-95001211012951 TRAY in 1 CASE (0121-1012-95) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1012-05)Marketed from Apr 28, 2023

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 50 mg/5mL
Dosage form
Solution
Route
Oral
Labeler
PAI Holdings, LLC dba PAI PharmaNDC labeler code 0121
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 216151
Marketing start
Listing expires
DEA schedule
CV
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 0121-1012_80024eb8-f6ab-420a-94df-dc5dd9ffb9b3SPL ID 80024eb8-f6ab-420a-94df-dc5dd9ffb9b3SPL set ID 75de00d8-d2e7-4025-be4e-f49299068e7eRxCUI 993856UNII 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

N400121101295 followed by a unit qualifier and the quantity

Package 00121-1012-95. 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 4 years of age and older (1.1) 1.1 Partial-Onset Seizures Lacosamide is 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) oral solution. However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0121-1012

What is NDC 0121-1012?
0121-1012 is the product NDC for Lacosamide, Lacosamide 50 mg/5mL solution, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. 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?
PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. 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?
144 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
LacosamideLacosamide 50 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-468970518-4689-0070518-4689-0270518-4689-03
LacosamideLacosamide 10 mg/mLInjection, SolutionIntravenousGLENMARK PHARMACEUTICALS INC., USA68462-69768462-0697-30
LacosamideLacosamide 100 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-456170518-4561-0070518-4561-02
LacosamideLacosamide 100 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-456270518-4562-00
LacosamideLacosamide 10 mg/mLInjection, SolutionIntravenousAnthea Pharma Private Limited83854-00283854-0002-10
LacosamideLacosamide 50 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-450370518-4503-00
LacosamideLacosamide 200 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-450470518-4504-0070518-4504-0170518-4504-03
LacosamideLacosamide 100 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-450570518-4505-00
LacosamideLacosamide 100 mg/10mLSolutionOralPrecision Dose, Inc.68094-17668094-0176-62
LacosamideLacosamide 50 mg/5mLSolutionOralPrecision Dose, Inc.68094-07668094-0076-62

All 145 Lacosamide NDCs

Other NDCs under ANDA 216151

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

FDA NDC Directory listings under ANDA 216151
ProductStrengthForm · routeLabelerProduct NDC
LacosamideLacosamide 100 mg/10mLSolutionOralPAI Holdings, LLC dba PAI Pharma0121-2024
LacosamideLacosamide 50 mg/5mLSolutionOralMajor Pharmaceuticals0904-7463
LacosamideLacosamide 100 mg/10mLSolutionOralMajor Pharmaceuticals0904-7464
LacosamideLacosamide 10 mg/mLSolutionOralANI Pharmaceuticals, Inc.70954-488
LacosamideLacosamide 150 mg/15mLSolutionOralPAI Holdings, LLC dba PAI Pharma0121-3036
LacosamideLacosamide 200 mg/20mLSolutionOralPAI Holdings, LLC dba PAI Pharma0121-4048

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Lacosamide NDC 0121-1012 | National Drug Code | Med-Code