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Terbinafine Hydrochloride 250 mg Tablet, 26,600-count — NDC 45201-526-00 (Billing 45201-0526-00)

by Laboratorios Liconsa SAU · 26600 TABLET in 1 DRUM

This is a package of 26,600 tablets of Terbinafine Hydrochloride 250 mg Tablet from Laboratorios Liconsa SAU, marketed since Nov 2018 and currently FDA-listed. It is this product's only package size.

NDC 45201-0526-00
🏷️ FDA NDC (as labeled) 45201-526-00 billing pads the product segment with a zero
On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 45201-526-00 alone.

Record
FDA NDC Directory package listing · Drug for further processing
Code segments
45201 labeler · 526 product · 00 package
Package marketed since
Nov 29, 2018
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 4520152600 4
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 45201-526-00
Product NDC 45201-526
11-digit billing NDC 45201052600
SPL Set ID 47de8622-6984-b189-e063-6294a90ab84e
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-11-29
Dosage form TABLET
Substance TERBINAFINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 45201-526-00 — 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 → 45201-0526-00. 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 depends on the form. The tablets treat fungal infections of the toenails or fingernails. Topical products like Lamisil AT treat athlete’s foot, jock itch and ringworm. Your doct...
  • You take one tablet by mouth once a day, with or without food. Fingernails take a shorter course than toenails. Your nail can look better only after healthy nail grows out, which t...
  • Liver failure has happened with terbinafine tablets, even in people with no liver problems. A blood test before and during treatment helps catch trouble early. Call your doctor rig...
  • Headache, diarrhea, rash, upset stomach and itching are the common ones, and they are usually mild. Call your doctor for taste or smell changes, low mood, blistering or spreading r...
📖 Read our full Terbinafine 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.

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
45201-0526-00 You're viewing this Main listing 26600 TABLET in 1 DRUM — — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
terbinafine hydrochloride 250 mg 69452-0351-13 Bionpharma 30 tablets $0.143 AB Availability likely —
Terbinafine 250 mg 60687-0909-21 American 30 tablets $0.143 AB Availability likely —
Terbinafine Hydrochloride 250 mg 51991-0526-01 Breckenridge 100 tablets $0.143 — Availability likely —
Terbinafine 250 mg 16714-0795-01 NorthStar 30 tablets $0.143 AB Availability likely —
Terbinafine Hydrochloride 250 mg 43353-0893-16 Aphena 6000 tablets — — FDA listed —
Terbinafine Hydrochloride 250 mg 71205-0127-14 Proficient 14 tablets — — FDA listed —
Terbinafine Hydrochloride 250 mg 50090-1048-00 A-S 30 tablets — — FDA listed —
Terbinafine Hydrochloride 250 mg 63629-1993-01 Bryant 100 tablets — — Discontinued —
terbinafine hydrochloride 250 mg 50090-7300-00 A-S 30 tablets — AB FDA listed —
Terbinafine 250 mg 70518-2941-00 REMEDYREPACK 30 tablets — AB FDA listed —
Terbinafine 250 mg 71335-1124-01 Bryant 30 tablets — AB FDA listed —
Terbinafine Hydrochloride 250 mg 43063-0906-20 PD-Rx 20 tablets — — FDA listed —
Terbinafine Hydrochloride 250 mg 55111-0250-01 Dr.Reddys 100 tablets — AB FDA listed —
Terbinafine Hydrochloride 250 mg 68071-4500-01 NuCare 100 tablets — — FDA listed —
terbinafine hydrochloride 250 mg 71335-9677-01 Bryant 30 tablets — AB FDA listed —
Terbinafine Hydrochloride 250 mg 65862-0079-01 Aurobindo 100 tablets — — FDA listed —
Terbinafine Hydrochloride 250 mgthis 45201-0526-00 Laboratorios 26600 tablets — — FDA listed —
Terbinafine 250 mg 50090-3654-00 A-S 30 tablets — AB FDA listed —
Terbinafine Hydrochloride 250 mg 68071-1640-03 NuCare 30 tablets — AB FDA listed —
Terbinafine 250 mg 71205-0492-30 Proficient 30 tablets — AB FDA listed —
Terbinafine Hydrochloride 250 mg 72162-1595-01 Bryant 100 tablets — — FDA listed —
Terbinafine Hydrochloride 250 mg 51991-0001-00 Breckenridge 26600 tablets — — FDA listed —
Terbinafine Hydrochloride 250 mg 60429-0222-30 Golden 30 tablets — — FDA listed —
Terbinafine 250 mg 68071-4873-03 NuCare 30 tablets — AB FDA listed —
Terbinafine 250 mg 68788-7450-01 Preferred 100 tablets — AB FDA listed —
terbinafine hydrochloride 250 mg 70518-3907-00 REMEDYREPACK 90 tablets — AB Discontinued —
Terbinafine 250 mg 71205-0061-30 Proficient 30 tablets — AB FDA listed —
Terbinafine Hydrochloride 250 mg 71335-0918-01 Bryant 30 tablets — — FDA listed —
Terbinafine 250 mg 72162-2539-01 Bryant 100 tablets — AB FDA listed —
terbinafine hydrochloride 250 mg 82804-0220-30 Proficient 30 tablets — AB FDA listed —
Terbinafine 250 mg 50090-3575-00 A-S 30 tablets — AB FDA listed —
Terbinafine Hydrochloride 250 mg 51655-0364-26 Northwind 90 tablets — — FDA listed —
Terbinafine 250 mg 72789-0394-42 PD-Rx 42 tablets — AB FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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

🏛️
2018
On the market since
Nov 2018
📍
2026
Currently FDA-listed
8 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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 Terbinafine 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

LabelerLaboratorios Liconsa SAU
Labeler code45201
First marketedNov 2018
Product typeDrug For Further Processing
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 FDA label FDA SPL

The complete FDA label for this product, 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 ↗

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 Terbinafine Hydrochloride — the ingredient across all brands.

Top reported reactions

Rash498
Pruritus420
Fatigue396
Nausea383
Pain349
Ageusia325
Headache306

Age at onset

Neonate3
Infant2
Child15
Adolescent19
Adult726
Elderly421

Reporter sex

8,840 reports
Male · 48%
Female · 52%
Unknown · 0%

Serious outcomes

Hospitalization2,349
Death532
Disabling451
Life-threatening366
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 893 311
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.

About this NDC listing & data coverage

Listed for further processing / repackaging

What "drug for further processing" means

FDA lists this package under the "drug for further processing" marketing category: Laboratorios Liconsa SAU supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.

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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Drug For Further Processing". Products approved under an application carry an NDA, ANDA, or BLA number.
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 Laboratorios Liconsa SAU. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Laboratorios Liconsa SAU 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.
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.
← 45149-0014-01 · Messer 45334-0206-07 · Pharmaceutical →
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.