HomeNDC LookupIngredientsLacosamide › 69539-0025-05
lacosamide 50 mg Tablet, Film Coated, 500-count — NDC 69539-0025-05 package photo

lacosamide 50 mg Tablet, Film Coated, 500-count

by MSN LABORATORIES PRIVATE LIMITED · 500 TABLET, FILM COATED in 1 BOTTLE (69539-025-05)
NDC 69539-0025-05
🏷️ FDA NDC (as labeled) 69539-025-05 billing pads the product segment with a zero
This package
Contains500-count Pack sizes2 compare ↓
Also priced by: Part D plans $0.5223/unit — full pricing hub ↓
Also comes in: 60 tablets 69539-0025-60
Rx only Generic On market CV
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for Lacosamide (different manufacturers) — 5 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jun 4, 2026 — Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg. (Annora Pharma Private Limited) · FDA recall D-0626-2026
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0343-2025
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0330-2025
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0321-2025
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0337-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 69539-025-05
Product NDC 69539-025
11-digit billing NDC 69539002505
UNII 563KS2PQY5
UPC 0369539025602, 0369539026609, 0369539027606, 0369539028603
Application # ANDA204921
SPL Set ID 0ae4e2d1-305d-4045-95da-cfe7c2d8b435
Physiologic effect Decreased Central Nervous System Disorganized Electrical Activity
DEA schedule CV
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-03-19
Route ORAL
Dosage form TABLET, FILM COATED
Substance LACOSAMIDE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 69539-025-05 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 69539-0025-05. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Other antiepileptics class.

Drug family (ATC) Other antiepileptics
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerMSN LABORATORIES PRIVATE LIMITED
Application holderMSN LABORATORIES PRIVATE LTD
FDA applicationANDA204921 (ANDA)
Labeler code69539
First marketedMar 2022
DEA scheduleCV
Product typeHuman Prescription Drug
Portfolio275 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📖 What it is MedlinePlus · NLM

Lacosamide is used to control partial onset seizures (seizures that involve only one part of the brain). Lacosamide is also used in combination with other medications to control primary generalized tonic-clonic seizures (formerly known as a grand mal seizure; seizure that involves the entire body). Lacosamide is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Lacosamide is used to treat seizures — specifically partial-onset seizures, which start in one part of the brain, in adults and children. It's also approved as an add-on treatment...
  • Yes — dizziness is the most commonly reported side effect of lacosamide, and it's most likely to happen during the early weeks when your dose is being increased. It usually gets be...
  • Is it normal to feel dizzy when I start this medication?
  • Please don't stop suddenly. Stopping lacosamide abruptly can cause a sudden increase in seizures, which can be dangerous. If you're having side effects or want to stop, talk to you...
📖 Read our full Lacosamide guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Pink / Yellow / Brown / Blue
ShapeOval
Imprint114
Size17 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 68401960MK
    Crospovidone is a synthetic polymer made from polyvinylpyrrolidone. It acts as a disintegrant, helping tablets break apart quickly in the stomach so the medicine dissolves and absorbs into the body.
  • UNII L06K8R7DQK
    A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII RFW2ET671P
    Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII 2165RE0K14
    A plant-based thickener made from cellulose that helps control how quickly the medicine dissolves and releases its active ingredient. It also binds ingredients together and improves the tablet's texture and handling during manufacturing.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

14 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.5223 $261.15 / 500 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lacosamide 50 mg 71921-0220-06 Florida 60 tablets $0.106 AB Availability likely
Lacosamide 50 mg 00904-7244-68 Major 1 tablet $0.115 AB Availability likely
Lacosamide 50 mg 16714-0548-01 NorthStar 60 tablets $0.115 AB Availability likely
Lacosamide 50 mg 33342-0302-09 Macleods 60 tablets $0.115 AB Availability likely
Lacosamide 50 mg 51991-0348-05 Breckenridge 500 tablets $0.115 AB Availability likely
Lacosamide 50 mg 60687-0676-57 American 1 tablet $0.115 AB Availability likely
Lacosamide 50 mg 69367-0348-60 Westminster 60 tablets $0.115 AB Availability likely
Lacosamide 50 mg 27808-0243-01 Tris 60 tablets $0.196 AB FDA listed
Vimpat 50 mg 00131-2477-35 UCB, 60 tablets $11.829 AB Availability likely
Lacosamide 50 mg 10135-0799-60 Marlex 60 tablets AB FDA listed
Lacosamide 50 mg 14445-0129-60 Indoco 60 tablets AB FDA listed
Lacosamide 50 mg 29300-0364-05 Unichem 500 tablets AB FDA listed
Lacosamide 50 mg 31722-0812-05 Camber 500 tablets AB FDA listed
Lacosamide 50 mg 46708-0171-10 Alembic 100 tablets AB FDA listed
Lacosamide 50 mg 47335-0918-18 Sun 1000 tablets AB FDA listed
Lacosamide 50 mg 50228-0192-10 ScieGen 1000 tablets AB FDA listed
Lacosamide 50 mg 51407-0721-60 Golden 60 tablets AB FDA listed
Lacosamide 50 mg 53746-0923-05 Amneal 500 tablets FDA listed
Lacosamide 50 mg 58118-8812-08 Clinical 30 tablets AB FDA listed
Lacosamide 50 mg 62332-0171-10 Alembic 10 tablets AB FDA listed
Lacosamide 50 mg 65862-0747-03 Aurobindo 10 tablets AB FDA listed
Lacosamide 50 mg 67877-0733-05 Ascend 500 tablets AB FDA listed
lacosamide 50 mg 68462-0678-10 Glenmark 1000 tablets AB FDA listed
lacosamide 50 mgthis 69539-0025-05 MSN 500 tablets AB FDA listed
Lacosamide 50 mg 70518-4503-00 REMEDYREPACK 30 tablets AB FDA listed
Lacosamide 50 mg 80425-0510-01 Advanced 30 tablets AB FDA listed
Lacosamide 50 mg 82804-0990-00 Proficient 100 tablets AB FDA listed
Lacosamide 50 mg 85742-0008-07 Kanchan 10 tablets AB FDA listed
Lacosamide 50 mg 70518-4689-00 REMEDYREPACK 1 tablet AB FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2022
On the market since
Mar 2022
📍
2026
Currently FDA-listed
4 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Lacosamide — the program that covers self-administered drugs. 19 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Lacosamide. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$22.96M
Claims incl. refills
274.3K
Beneficiaries
110.1K
Spend / beneficiary
$208.50
Spend / claim
$83.71
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Lacosamide — the ingredient across all brands.

Top reported reactions

Seizure6,858
Dizziness1,669
Somnolence1,497
Fatigue1,446
Epilepsy1,418
Fall1,395
Overdose1,279

Age at onset

Neonate328
Infant111
Child299
Adolescent158
Adult2,071
Elderly709

Reporter sex

36,995 reports
Male · 45%
Female · 55%
Unknown · 1%

Serious outcomes

Hospitalization12,683
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3,766 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
69539-0025-05 You're viewing this 500 TABLET, FILM COATED in 1 BOTTLE (69539-025-05) 2022-03-19 Active
69539-0025-60 60 TABLET, FILM COATED in 1 BOTTLE (69539-025-60) 2022-03-19 Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 69539-0025-05?
NDC 69539-0025-05 is a 500-count package — 500 tablet, film coated in 1 bottle.
What is the difference between NDC 69539-0025-05 and NDC 69539-0025-60?
Both are lacosamide 50 mg Tablet, Film Coated — the drug itself is identical. NDC 69539-0025-05 is the 500-count package, while NDC 69539-0025-60 is the 60 tablets package.
What NDC number is used to bill for this package of lacosamide 50 mg Tablet, Film Coated?
Bill NDC 69539-0025-05 — the 11-digit billing format is 69539002505. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 69539-025-05, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 69539-0025-05, written without dashes as 69539002505. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 69539-0025-05, the first segment (69539) is the labeler code FDA assigned to MSN LABORATORIES PRIVATE LIMITED; the middle segment (0025) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by MSN LABORATORIES PRIVATE LIMITED. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 60 tablets (69539-0025-60). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
MSN LABORATORIES PRIVATE LIMITED is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label 9 words

No readable label sections were found for this product.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.