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Lamotrigine Lamotirigine 50 mg Tablet, Extended Release, 500-count — NDC 70771-1515-05 package photo

Lamotrigine Lamotirigine 50 mg Tablet, Extended Release, 500-count

by Zydus Lifesciences Limited · 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1515-5)
NDC 70771-1515-05
🏷️ FDA NDC (as labeled) 70771-1515-5 billing pads the package segment with a zero
This package
Contains500-count Pack sizes4 compare ↓
Also comes in: 10 tablets 70771-1515-04 30 tablets 70771-1515-03 90 tablets 70771-1515-09
Rx only Generic On market Non-controlled
🗂️ 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 →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 70771-1515-5
Product NDC 70771-1515
11-digit billing NDC 70771151505
RxCUI 850087, 850091, 900156, 900164, 1098608, 1146690
UNII U3H27498KS
Application # ANDA207763
SPL Set ID ecb7a528-699f-4e51-9887-dee60456da2f
Established class (EPC) Anti-epileptic Agent; Mood Stabilizer
Mechanism of action Organic Cation Transporter 2 Inhibitors; Dihydrofolate Reductase Inhibitors
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 2020-05-14
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance LAMOTRIGINE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 70771-1515-5 — 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 → 70771-1515-05. 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 Mood Stabilizer class.

Pharmacologic class Mood Stabilizer, Anti-epileptic Agent
Drug family (ATC) Other antiepileptics
How it works Dihydrofolate Reductase Inhibitors, Organic Cation Transporter 2 Inhibitors
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

LabelerZydus Lifesciences Limited
Application holderZYDUS PHARMACEUTICALS USA INC
FDA applicationANDA207763 (ANDA)
Labeler code70771
First marketedMay 2020
Product typeHuman Prescription Drug
Portfolio717 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

Lamotrigine extended-release (long-acting) tablets are used with other medications to treat certain types of seizures in patients who have epilepsy. All types of lamotrigine tablets (tablets, orally disintegrating tablets, and chewable tablets) other than the extended-release tablets are used alone or with other medications to treat seizures in people who have epilepsy or Lennox-Gastaut syndrome (a disorder that causes seizures and often causes developmental delays). All types of lamotrigine tablets other than the extended-release tablets are also used to increase the time between episodes of...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • I completely understand the impatience — but the slow ramp-up is one of the most important safety steps with lamotrigine. Going too fast significantly raises your risk of a serious...
  • Why does my doctor keep telling me to increase my dose so slowly? Can't we just get to the right dose faster?
  • That's a fair question, and the honest answer is: with lamotrigine, we can't reliably tell in advance which rashes are harmless and which are dangerous. So the rule is — call your...
  • What kind of rash should I worry about? I get skin reactions from all sorts of things.
📖 Read our full Lamotrigine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 Yellow / Green / Orange / Blue / Purple / Gray
ShapeOval
Imprint984
Size16 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 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • 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 EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • 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 NX76LV5T8J
    A synthetic plastic polymer made from methacrylic acid and ethyl acrylate. It's used as a coating or binder to control how and where the medicine dissolves in your digestive system.
  • 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 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • 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.
  • UNII 8Z96QXD6UM
    Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

13 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 DailyMed — ingredient 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 · 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.
Try another pack size: 10 tablets 30 tablets 90 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
Lamotrigine 50 mg 00228-1435-03 Actavis 30 tablets $0.524 AB Discontinued —
Lamotrigine 50 mg 16714-0624-01 NorthStar 30 tablets $0.524 AB Availability likely —
lamotrigine 50 mg 31722-0241-30 Camber 30 tablets $0.524 AB Availability likely —
Lamotrigine 50 mg 65162-0956-03 Amneal 30 tablets $0.524 AB Availability likely —
Lamictal Xr 50 mg 00173-0755-00 GlaxoSmithKline 30 tablets $28.322 AB Availability likely —
Lamotrigine 50 mg 13668-0340-01 Torrent 100 tablets — AB FDA listed —
Lamotrigine 50 mg 42291-0444-30 AvKARE 30 tablets — AB FDA listed —
Lamotrigine 50 mg 55111-0718-05 Dr.Reddy's 500 tablets — AB FDA listed —
Lamotrigine 50 mg 68382-0980-05 Zydus 500 tablets — AB FDA listed —
lamotrigine 50 mg 69117-0045-01 Yiling 30 tablets — AB FDA listed —
Lamotrigine 50 mg 70518-1153-01 REMEDYREPACK 1 tablet — AB FDA listed —
Lamotrigine 50 mg 70518-4121-00 REMEDYREPACK 30 tablets — AB FDA listed —
lamotrigine 50 mg 70518-4442-00 REMEDYREPACK 30 tablets — AB FDA listed —
Lamotrigine 50 mgthis 70771-1515-05 Zydus 500 tablets — AB FDA listed —
lamotrigine 50 mg 82804-0022-30 Proficient 30 tablets — AB FDA listed —
Lamotrigine 50 mg 82804-0105-30 Proficient 30 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

🏛️
2020
On the market since
May 2020
📍
2026
Currently FDA-listed
6 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 Lamotrigine — the program that covers self-administered drugs. 15 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 Lamotrigine. 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
$16.58M
Claims incl. refills
1.1M
Beneficiaries
533.3K
Spend / beneficiary
$31.09
Spend / claim
$15.37
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
70771-1515-03 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1515-3) 2020-05-14 Active
70771-1515-04 10 BLISTER PACK in 1 CARTON (70771-1515-4) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70771-1515-2) 2020-05-14 Active
70771-1515-05 You're viewing this 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1515-5) 2020-05-14 Active
70771-1515-09 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1515-9) 2020-05-14 Active

Pack size FAQ

What quantity is in NDC 70771-1515-05?
NDC 70771-1515-05 is a 500-count package — 500 tablet, extended release in 1 bottle.
What is the difference between NDC 70771-1515-05 and NDC 70771-1515-03?
Both are Lamotrigine Lamotirigine 50 mg Tablet, Extended Release — the drug itself is identical. NDC 70771-1515-05 is the 500-count package, while NDC 70771-1515-03 is the 30 tablets package.
What NDC number is used to bill for this package of Lamotrigine Lamotirigine 50 mg Tablet, Extended Release?
Bill NDC 70771-1515-05 — the 11-digit billing format is 70771151505. 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 70771-1515-5, 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: 70771-1515-05, written without dashes as 70771151505. 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 70771-1515-05, the first segment (70771) is the labeler code FDA assigned to Zydus Lifesciences Limited; the middle segment (1515) 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 Zydus Lifesciences 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 3 other package presentations of this same product, including 10 tablets (70771-1515-04), 30 tablets (70771-1515-03), 90 tablets (70771-1515-09). 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?
Zydus Lifesciences 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.
💬 Medication Guide
💬 Medication Guide 2 words ▾

SPL MEDGUIDE

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70771-1514-03 · Zydus 70771-1516-03 · Zydus →
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.