Prescription drug · ANDA

Lacosamide NDC 67877-734

Lacosamide 100 mg/1 · Tablet, Film coated · Oral · Ascend Laboratories, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)67877-734Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67877-0734Add 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
67877-734-0567877073405500 TABLET, FILM COATED in 1 BOTTLE (67877-734-05)Marketed from Apr 1, 2022
67877-734-31678770734316 BLISTER PACK in 1 CARTON (67877-734-31) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Apr 1, 2022
67877-734-606787707346060 TABLET, FILM COATED in 1 BOTTLE (67877-734-60)Marketed from Apr 1, 2022
67877-734-906787707349090 TABLET, FILM COATED in 1 BOTTLE (67877-734-90)Marketed from Apr 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 — 100 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 214695
Marketing start
Listing expires
DEA schedule
CV
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 67877-734_062a789f-52f0-482b-9ec0-2ba3ac1572ecSPL ID 062a789f-52f0-482b-9ec0-2ba3ac1572ecSPL set ID 9d7fde23-dc3f-41e9-89cf-6a1a9eeaa7deRxCUI 809987, 809992, 809996, 810000UNII 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

N467877073405 followed by a unit qualifier and the quantity

Package 67877-0734-05. 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 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 tablets are indicated for the treatment of partial-onset seizures in patients 4 years 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. Additional pediatric use information is approved for UCB, Inc.'s VIMPAT ® (lacosamide) tablets. However, due t…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 214695

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

FDA NDC Directory listings under ANDA 214695
ProductStrengthForm · routeLabelerProduct NDC
LacosamideLacosamide 100 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7245
LacosamideLacosamide 150 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7246
LacosamideLacosamide 150 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-735
LacosamideLacosamide 200 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7247
LacosamideLacosamide 50 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-733
LacosamideLacosamide 200 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-736
LacosamideLacosamide 50 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4689
LacosamideLacosamide 50 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-0510
LacosamideLacosamide 100 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4561
LacosamideLacosamide 50 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-676
LacosamideLacosamide 100 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-687
LacosamideLacosamide 200 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-698
LacosamideLacosamide 50 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7244

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Lacosamide NDC 67877-734 | Med-Code