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Lacosamide 100 mg Tablet, 100-count — NDC 50268-492-10 (Billing 50268-0492-10)

by AvPAK · 100 BLISTER PACK in 1 BOX / 1 TABLET in 1 BLISTER PACK

This is a package of 100 tablets of Lacosamide 100 mg Tablet from AvPAK, marketed since Sep 2026 and currently FDA-listed. It is this product's only package size.

NDC 50268-0492-10
🏷️ FDA NDC (as labeled) 50268-492-10 billing pads the product segment with a zero
Rx only Generic On market CV ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 8, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 50268-492-10 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
50268 labeler · 492 product · 10 package
Package marketed since
Sep 29, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5026849210 0
FDA record last changed
Oct 8, 2026
⚠️
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50268-492-10
Product NDC 50268-492
11-digit billing NDC 50268049210
Application # ANDA208308
SPL Set ID 5ca5b051-08b7-2b4d-e063-6294a90a144b
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 2026-09-29
Route ORAL
Dosage form TABLET
Substance LACOSAMIDE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 50268-492-10 — 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 → 50268-0492-10. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It treats partial-onset seizures, and it is also used as add-on treatment for primary generalized tonic-clonic seizures. Which age groups it covers depends on the product, so your...
  • Tablets and oral solution are usually taken twice a day, with or without food. Motpoly XR is a once-daily capsule that you swallow whole, without opening, chewing or crushing. Foll...
  • Dizziness is the big one, along with headache, double or blurry vision, nausea, sleepiness and balance trouble. These are most noticeable when starting or raising the dose. Tell yo...
  • Call right away for fainting, a very slow or irregular heartbeat, or new or worsening depression or suicidal thoughts. Also call for fever with rash or swelling, which can be a ser...
📖 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.

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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
50268-0492-10 You're viewing this Main listing 100 BLISTER PACK in 1 BOX / 1 TABLET in 1 BLISTER PACK 2026-09-29 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lacosamide 100 mg 71921-0221-06 Florida 60 tablets $0.167 AB Availability likely —
Lacosamide 100 mg 33342-0303-09 Macleods 60 tablets $0.174 AB Availability likely —
Lacosamide 100 mg 69367-0349-60 Westminster 60 tablets $0.174 AB Availability likely —
Lacosamide 100 mg 16714-0549-01 NorthStar 60 tablets $0.174 AB Availability likely —
Lacosamide 100 mg 00904-7245-68 Major 1 tablet $0.174 AB Availability likely —
Lacosamide 100 mg 51991-0349-05 Breckenridge 500 tablets $0.174 AB Availability likely —
Lacosamide 100 mg 60687-0687-57 American 1 tablet $0.174 AB Availability likely —
Lacosamide 100 mg 27808-0244-01 Tris 60 tablets $0.311 AB FDA listed —
Vimpat 100 mg 00131-2478-35 UCB, 60 tablets $18.537 AB Availability likely —
Lacosamide 100 mg 14445-0130-60 Indoco 60 tablets — AB FDA listed —
lacosamide 100 mg 69539-0026-05 MSN 500 tablets — AB FDA listed —
Lacosamide 100 mg 46708-0172-10 Alembic 100 tablets — AB FDA listed —
Lacosamide 100 mg 62332-0172-10 Alembic 10 tablets — AB FDA listed —
Lacosamide 100 mg 85742-0009-07 Kanchan 10 tablets — AB FDA listed —
lacosamide 100 mg 68462-0679-10 Glenmark 1000 tablets — AB FDA listed —
Lacosamide 100 mg 65862-0748-03 Aurobindo 10 tablets — AB FDA listed —
Lacosamide 100 mg 70518-4505-00 REMEDYREPACK 30 tablets — AB FDA listed —
Lacosamide 100 mg 58118-8813-08 Clinical 30 tablets — AB FDA listed —
Lacosamide 100 mg 70518-4561-00 REMEDYREPACK 1 tablet — AB FDA listed —
Lacosamide 100 mg 70518-4562-00 REMEDYREPACK 1 tablet — AB FDA listed —
Lacosamide 100 mg 10135-0800-60 Marlex 60 tablets — AB FDA listed —
Lacosamide 100 mg 29300-0365-05 Unichem 500 tablets — AB FDA listed —
Lacosamide 100 mg 31722-0813-05 Camber 500 tablets — AB FDA listed —
Lacosamide 100 mg 50228-0193-10 ScieGen 1000 tablets — AB FDA listed —
Lacosamide 100 mg 51407-0722-60 Golden 60 tablets — AB FDA listed —
Lacosamide 100 mg 53746-0924-05 Amneal 500 tablets — — FDA listed —
Lacosamide 100 mg 47335-0922-18 Sun 1000 tablets — AB FDA listed —
Lacosamide 100 mg 82804-0991-00 Proficient 100 tablets — AB FDA listed —
Lacosamide 100 mg 67877-0734-05 Ascend 500 tablets — AB FDA listed —
Lacosamide 100 mgthis 50268-0492-10 AvPAK 100 tablets — 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

🏛️
2026
On the market since
Sep 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

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.

🧪 Avoiding an ingredient? See Lacosamide inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.

Manufacturer & labeler

LabelerAvPAK
Application holderREGCON HOLDINGS LLC
FDA applicationANDA208308 (ANDA)
Labeler code50268
First marketedSep 2026
DEA scheduleCV
Product typeHuman Prescription Drug
Portfolio350 products on file

More NDCs from AvPAK labeler code 50268

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.

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
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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.

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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 AvPAK. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
AvPAK 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.
← 50268-0491-10 · AvPAK 50268-0495-15 · AvPAK →
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.