NDC codes

FDA NDC Directory
Product NDC (as listed)72603-305Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72603-0305Add 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
72603-305-017260303050172603030501200 mL in 1 BOTTLE, PLASTIC (72603-305-01)Marketed from Jun 1, 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
Solution
Route
Oral
Labeler
NorthStar Rx LLCNDC labeler code 72603
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209224
Marketing start
Listing expires
DEA schedule
CV
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 72603-305_bf8d1cc8-a30b-43e8-b698-a5b1fc7e3520SPL ID bf8d1cc8-a30b-43e8-b698-a5b1fc7e3520SPL set ID 48fcaa27-baaa-446e-a282-0c3e232cd151RxCUI 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

N472603030501 followed by a unit qualifier and the quantity

Package 72603-0305-01. 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 .

Indications (excerpt from the label)

Lacosamide oral solution 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 oral solution 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 oral solution 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)

About NDC 72603-305

What is NDC 72603-305?
72603-305 is the product NDC for Lacosamide, Lacosamide 10 mg/mL solution, listed with the FDA by NorthStar Rx 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?
NorthStar Rx LLC, NDC labeler code 72603. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
LacosamideLacosamide 50 mg/1TabletOralAvPAK50268-49150268-0491-10
LacosamideLacosamide 100 mg/1TabletOralAvPAK50268-49250268-0492-10
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.70518-456270518-4562-00
LacosamideLacosamide 100 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-456170518-4561-0070518-4561-02
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

All 147 Lacosamide NDCs

Other NDCs under ANDA 209224

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

FDA NDC Directory listings under ANDA 209224
ProductStrengthForm · routeLabelerProduct NDC
LacosamideLacosamide 10 mg/mLSolutionOralAurobindo Pharma Limited59651-016
LacosamideLacosamide 10 mg/mLSolutionOralAmerican Health Packaging60687-847

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