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Levetiracetam 500 mg Tablet, Film Coated, Extended Release, 500-count — NDC 60505-3280-5 (Billing 60505-3280-05)

by Apotex Corp. · 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

This is a package of 500 tablets of Levetiracetam 500 mg Tablet, Film Coated, Extended Release from Apotex Corp., marketed since Sep 2011 and currently FDA-listed.

NDC 60505-3280-05
🏷️ FDA NDC (as labeled) 60505-3280-5 billing pads the package segment with a zero
This package
Contains500-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.3211/unit — full pricing hub ↓
Product page 60505-3280-06 Also comes in: 60 tablets 60505-3280-6 1000 tablets 60505-3280-8
Rx only Generic On market Non-controlled ⇄ 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 60505-3280-5 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
60505 labeler · 3280 product · 5 package
Package marketed since
Sep 12, 2011
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 6050532805 5
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 60505-3280-5
Product NDC 60505-3280
11-digit billing NDC 60505328005
Application # ANDA091261
SPL Set ID 24652d3c-86ad-7b6e-6a54-d0a6f952c913
Physiologic effect Decreased Central Nervous System Disorganized Electrical Activity
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-09-12
Route ORAL
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Substance LEVETIRACETAM
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 064416
GCN 14305
HICL code 020952
Ingredient (HICL) Levetiracetam
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H4
Therapeutic class — intermediate (HIC2) Anticonvulsants
HIC3 code H4B
Therapeutic class — specific (HIC3) Anticonvulsants
AHFS code 28:12.92.00
AHFS class Anticonvulsants, Miscellaneous
FDB label name LEVETIRACETAM ER 500 MG TABLET
FDB brand name Levetiracetam Er
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 064416
  • GCN: 14305
  • HICL (First Databank): 020952
  • AHFS class code: 28:12.92.00
Why two NDCs? The FDA registers this code as 60505-3280-5 — a 5-4-1 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 package segment → 60505-3280-05. 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.

Clinical

Label name LEVETIRACETAM ER 500 MG TABLET Ingredient Levetiracetam
📖 What it is MedlinePlus · NLM

Levetiracetam is used alone and along with other medications to control partial-onset seizures (seizures that involve only one part of the brain) in adults, children, and infants 1 month of age or older. Levetiracetam is also used in combination with other medications to treat seizure in adults and children 12 years of age or older with juvenile myoclonic epilepsy. Levetiracetam is also used in combination with other medications to treat primary generalized tonic-clonic seizures (formerly known as a grand mal seizure; seizure that involves the entire body) in adults and children 6 years of age...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats seizures in epilepsy. Depending on the product, that means partial-onset seizures, and as add-on therapy, myoclonic seizures in juvenile myoclonic epilepsy and primary ge...
  • Follow your prescriber and label. Tablets and solution are usually twice daily, while extended-release tablets are once daily and must be swallowed whole. Use a calibrated device f...
  • Sleepiness, tiredness, dizziness and headache are common, especially early on. Children may become irritable or aggressive. Avoid driving until you know how it affects you.
  • Call right away for new or worsening depression, suicidal thoughts, unusual behavior, a rash, swelling of the face or throat, or trouble walking. Get emergency help for trouble bre...
📖 Read our full Levetiracetam guide →
1
Nutrient depletion considerations

Levetiracetam may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Levetiracetam nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 · Q2 2026 $0.3211 $160.55 / 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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
60505-3280-05 You're viewing this 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE — — 2011-09-12 — Active
60505-3280-06 60505-3280-6 Main listing 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE $0.1738 / ea $10.43 2011-09-12 — Active
60505-3280-08 60505-3280-8 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE — — 2011-09-12 — Active

You're viewing one of 3 pack sizes for this product.

This pack shows little to no recent Medicaid volume — the 60 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 500-count package — 500 tablet, film coated, extended release in 1 bottle.
How does this package differ from NDC 60505-3280-06?
Both are Levetiracetam 500 mg Tablet, Film Coated, Extended Release — the drug itself is identical. This page's package is the 500-count one, while NDC 60505-3280-06 is the 60 tablets package.
What NDC number is used to bill for this package of Levetiracetam 500 mg Tablet, Film Coated, Extended Release?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Levetiracetam 500 mg 43547-0345-06 Solco 60 tablets $0.174 AB Availability likely —
Levetiracetam 500 mg 68001-0113-06 BluePoint 60 tablets $0.174 AB Availability likely —
Levetiracetam ER 500 mg 69367-0332-60 Westminster 60 tablets $0.174 AB Availability likely —
Keppra XR 500 mg 50474-0598-66 UCB, 60 tablets $9.024 AB Availability likely —
Levetiracetam 500 mg 13668-0272-05 Torrent 500 tablets — AB FDA listed —
Levetiracetam Extended-Release 500 mg 50228-0189-05 ScieGen 500 tablets — AB FDA listed —
Levetiracetam Extended-Release 500 mg 60429-0349-60 Golden 60 tablets — AB FDA listed —
Levetiracetam 500 mgthis 60505-3280-05 Apotex 500 tablets — AB FDA listed —
Levetiracetam 500 mg 63629-9847-01 Bryant 21 tablets — AB FDA listed —
Levetiracetam 500 mg 68180-0117-02 Lupin 500 tablets — AB FDA listed —
Levetiracetam 500 mg 70518-4005-01 REMEDYREPACK 30 tablets — AB FDA listed —
Levetiracetam ER 500 mg 70518-4125-00 REMEDYREPACK 30 tablets — AB FDA listed —
Levetiracetam ER 500 mg 71205-0728-30 Proficient 30 tablets — AB FDA listed —
Levetiracetam ER 500 mg 71205-0880-00 Proficient 100 tablets — AB FDA listed —
Levetiracetam ER 500 mg 72189-0510-60 Direct_Rx 60 tablets — AB FDA listed —
LEVETIRACETAM Extended-release 500 mg 81665-0101-12 Omnivium 120 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

🏛️
2011
On the market since
Sep 2011
📍
2026
Currently FDA-listed
15 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.

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 Levetiracetam 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

LabelerApotex Corp.
Application holderAPOTEX INC
FDA applicationANDA091261 (ANDA)
Labeler code60505
First marketedSep 2011
Product typeHuman Prescription Drug
Portfolio313 products on file

More NDCs from Apotex Corp. labeler code 60505

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 ↗

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
60 tablets60505-3280-06 2,360 Rx · $110,741
500 tablets this page60505-3280-05 No Medicaid data
1000 tablets60505-3280-08 No Medicaid data
Drug total (last 4 qtrs): 2,360 Rx · 439,357 units · $110,741 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Levetiracetam — the program that covers self-administered drugs. 30 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 Levetiracetam. 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
$42.44M
Claims incl. refills
1.2M
Beneficiaries
606K
Spend / beneficiary
$70.03
Spend / claim
$35.28
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 Apotex Corp.. 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 2 other package presentations of this same product, including 60 tablets (60505-3280-06), 1000 tablets (60505-3280-08). 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?
Apotex Corp. 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.
← 60505-3278-00 · Apotex 60505-3438-03 · Apotex →
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.