NDC codes

FDA NDC Directory
Product NDC (as listed)16714-552Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16714-0552Add 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
16714-552-01167140552011671405520160 TABLET in 1 BOTTLE (16714-552-01)Marketed from Aug 1, 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 — 200 mg/1
Dosage form
Tablet
Route
Oral
Labeler
NorthStar RxLLCNDC labeler code 16714
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208308
Marketing start
Listing expires
DEA schedule
CV
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 16714-552_ad8753cb-70b7-431e-9d52-93558d469ef5SPL ID ad8753cb-70b7-431e-9d52-93558d469ef5SPL set ID 9dffda6c-9e44-478f-9e02-9da3ab4c50e1RxCUI 809987, 809992, 809996, 810000UNII 563KS2PQY5UPC 0316714548012, 0316714550015, 0316714552019, 0316714549019

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

N416714055201 followed by a unit qualifier and the quantity

Package 16714-0552-01. 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 tablets are 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 1 month of age and older ( 1.2 ) 1.1 Partial-Onset Seizures Lacosamide tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older. 1.2 Primary Generalized Tonic-Clonic Seizures Lacosamide tablets are 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 16714-552

What is NDC 16714-552?
16714-552 is the product NDC for Lacosamide, Lacosamide 200 mg/1 tablet, listed with the FDA by NorthStar RxLLC. 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 RxLLC, NDC labeler code 16714. 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 208308

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

FDA NDC Directory listings under ANDA 208308
ProductStrengthForm · routeLabelerProduct NDC
LacosamideLacosamide 50 mg/1TabletOralIndoco Remedies Limited14445-129
LacosamideLacosamide 100 mg/1TabletOralIndoco Remedies Limited14445-130
LacosamideLacosamide 150 mg/1TabletOralIndoco Remedies Limited14445-131
LacosamideLacosamide 200 mg/1TabletOralIndoco Remedies Limited14445-132
LacosamideLacosamide 50 mg/1TabletOralNorthStar RxLLC16714-548
LacosamideLacosamide 100 mg/1TabletOralNorthStar RxLLC16714-549
LacosamideLacosamide 150 mg/1TabletOralNorthStar RxLLC16714-550
LacosamideLacosamide 50 mg/1TabletOralTris Pharma Inc27808-243
LacosamideLacosamide 100 mg/1TabletOralTris Pharma Inc27808-244
LacosamideLacosamide 150 mg/1TabletOralTris Pharma Inc27808-245
LacosamideLacosamide 200 mg/1TabletOralTris Pharma Inc27808-246
LacosamideLacosamide 50 mg/1TabletOralAvPAK50268-491
LacosamideLacosamide 100 mg/1TabletOralAvPAK50268-492
LacosamideLacosamide 50 mg/1TabletOralFlorida Pharmaceutical Products, LLC71921-220
LacosamideLacosamide 100 mg/1TabletOralFlorida Pharmaceutical Products, LLC71921-221
LacosamideLacosamide 150 mg/1TabletOralFlorida Pharmaceutical Products, LLC71921-222
LacosamideLacosamide 200 mg/1TabletOralFlorida Pharmaceutical Products, LLC71921-223

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