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Terbinafine Hydrochloride 250 mg Tablet, 90-count — NDC 71205-0127-90 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Terbinafine Hydrochloride 250 mg Tablet, 90-count — NDC 71205-127-90 (Billing 71205-0127-90)

by Proficient Rx LP · 90 TABLET in 1 BOTTLE

This is a package of 90 tablets of Terbinafine Hydrochloride 250 mg Tablet from Proficient Rx LP, marketed since Dec 2010 and currently FDA-listed.

NDC 71205-0127-90
🏷️ FDA NDC (as labeled) 71205-127-90 billing pads the product segment with a zero
This package
Contains90-count Pack sizes8 compare ↓
Also priced by: Part D plans $0.3660/unit — full pricing hub ↓
Product page 71205-0127-14 Also comes in: 14 tablets 71205-127-14 15 tablets 71205-127-15 30 tablets 71205-127-30 35 tablets 71205-127-35 42 tablets 71205-127-42 45 tablets 71205-127-45 60 tablets 71205-127-60
Rx only Generic 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71205-127-90
Product NDC 71205-127
11-digit billing NDC 71205012790
RxCUI 313222
UNII 012C11ZU6G
UPC 0371205127145
Application # ANDA077714
SPL Set ID 4e515f99-7fc7-4692-9105-8e87c27d4e79
Established class (EPC) Allylamine Antifungal
Chemical class Allylamine
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2010-12-27
Route ORAL
Dosage form TABLET
Substance TERBINAFINE HYDROCHLORIDE

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

GPI-14 11000080100310
GPI class Terbinafine HCl
GCN Seq No 018638
GCN 60823
HICL code 007590
Ingredient (HICL) Terbinafine Hcl
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W3
Therapeutic class — intermediate (HIC2) Antimycotics
HIC3 code W3B
Therapeutic class — specific (HIC3) Antifungal Agents
AHFS code 08:14.04.00
AHFS class Allylamine Antifungals
FDB label name TERBINAFINE HCL 250 MG TABLET
FDB brand name Terbinafine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 018638
  • GCN: 60823
  • GPI-14 (Medi-Span): 11000080100310
  • HICL (First Databank): 007590
  • AHFS class code: 08:14.04.00
  • RxCUI (RxNorm): 313222
Why two NDCs? The FDA registers this code as 71205-127-90 — 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 → 71205-0127-90. 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 Allylamine Antifungal class.

Pharmacologic class Allylamine Antifungal
Drug family (ATC) Other antifungals for topical use, Antifungals for systemic use
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.

Clinical

Label name TERBINAFINE HCL 250 MG TABLET Ingredient Terbinafine Hcl
📗 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 · Q2 2026 $0.3660 $32.94 / 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
71205-0127-14 71205-127-14 Main listing 14 TABLET in 1 BOTTLE 2022-05-17 — Active
71205-0127-15 71205-127-15 15 TABLET in 1 BOTTLE 2018-10-01 — Active
71205-0127-30 71205-127-30 30 TABLET in 1 BOTTLE 2018-10-01 — Active
71205-0127-35 71205-127-35 35 TABLET in 1 BOTTLE 2018-10-01 — Active
71205-0127-42 71205-127-42 42 TABLET in 1 BOTTLE 2022-08-15 — Active
71205-0127-45 71205-127-45 45 TABLET in 1 BOTTLE 2018-10-01 — Active
71205-0127-60 71205-127-60 60 TABLET in 1 BOTTLE 2022-05-17 — Active
71205-0127-90 You're viewing this 90 TABLET in 1 BOTTLE 2022-05-17 — Active

You're viewing the largest of 8 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 90-count package — 90 tablet in 1 bottle.
How does this package differ from NDC 71205-0127-14?
Both are Terbinafine Hydrochloride 250 mg Tablet — the drug itself is identical. This page's package is the 90-count one, while NDC 71205-0127-14 is the 14 tablets package.
What NDC number is used to bill for this package of Terbinafine Hydrochloride 250 mg Tablet?
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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Terbinafine 250 mg 16714-0795-01 NorthStar 30 tablets $0.143 AB Availability likely —
Terbinafine Hydrochloride 250 mg 51991-0526-01 Breckenridge 100 tablets $0.143 — Availability likely —
Terbinafine 250 mg 60687-0909-21 American 30 tablets $0.143 AB Availability likely —
Terbinafine 250 mg 62135-0572-30 Chartwell 30 tablets $0.143 AB Availability likely —
Terbinafine 250 mg 69097-0859-02 Cipla 30 tablets $0.143 — Availability likely —
Terbinafine Hydrochloride 250 mg 69292-0225-01 Amici 100 tablets $0.143 AB Availability likely —
terbinafine hydrochloride 250 mg 69452-0351-13 Bionpharma 30 tablets $0.143 AB Availability likely —
Terbinafine Hydrochloride 250 mg 69097-0731-02 Cipla 30 tablets $0.154 AB FDA listed —
Terbinafine Hydrochloride 250 mg 43063-0906-20 PD-Rx 20 tablets — — FDA listed —
Terbinafine Hydrochloride 250 mg 43353-0893-16 Aphena 6000 tablets — — FDA listed —
Terbinafine Hydrochloride 250 mg 50090-1048-00 A-S 30 tablets — — FDA listed —
Terbinafine 250 mg 50090-3575-00 A-S 30 tablets — AB FDA listed —
Terbinafine 250 mg 50090-3654-00 A-S 30 tablets — AB FDA listed —
terbinafine hydrochloride 250 mg 50090-7300-00 A-S 30 tablets — AB FDA listed —
Terbinafine Hydrochloride 250 mg 51407-0995-01 Golden 100 tablets — AB FDA listed —
Terbinafine Hydrochloride 250 mg 51655-0364-26 Northwind 90 tablets — — FDA listed —
Terbinafine Hydrochloride 250 mg 55111-0250-01 Dr.Reddys 100 tablets — AB FDA listed —
Terbinafine Hydrochloride 250 mg 60429-0222-30 Golden 30 tablets — — FDA listed —
Terbinafine Hydrochloride 250 mg 63629-1993-01 Bryant 100 tablets — — Discontinued —
Terbinafine Hydrochloride 250 mg 65862-0079-01 Aurobindo 100 tablets — — FDA listed —
Terbinafine Hydrochloride 250 mg 68071-1640-03 NuCare 30 tablets — AB FDA listed —
Terbinafine Hydrochloride 250 mg 68071-2381-03 NuCare 30 tablets — AB FDA listed —
Terbinafine Hydrochloride 250 mg 68071-4500-01 NuCare 100 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 250 mg 70518-2941-00 REMEDYREPACK 30 tablets — AB FDA listed —
terbinafine hydrochloride 250 mg 70518-3907-00 REMEDYREPACK 90 tablets — AB Discontinued —
Terbinafine 250 mg 70518-4323-00 REMEDYREPACK 30 tablets — — Discontinued —
Terbinafine 250 mg 70518-4421-00 REMEDYREPACK 90 tablets — — FDA listed —
Terbinafine 250 mg 71205-0061-30 Proficient 30 tablets — AB FDA listed —
Terbinafine Hydrochloride 250 mgthis 71205-0127-90 Proficient 90 tablets — — FDA listed —
Terbinafine 250 1 71205-0152-15 Proficient 15 tablets — — FDA listed —
Terbinafine 250 mg 71205-0492-30 Proficient 30 tablets — AB FDA listed —
Terbinafine Hydrochloride 250 mg 71335-0918-01 Bryant 30 tablets — — FDA listed —
Terbinafine 250 mg 71335-1124-01 Bryant 30 tablets — AB FDA listed —
terbinafine hydrochloride 250 mg 71335-9677-01 Bryant 30 tablets — AB FDA listed —
Terbinafine Hydrochloride 250 mg 72162-1595-01 Bryant 100 tablets — — FDA listed —
Terbinafine 250 mg 72162-2539-01 Bryant 100 tablets — AB FDA listed —
Terbinafine 250 mg 72189-0243-30 direct 30 tablets — AB FDA listed —
Terbinafine 250 mg 72789-0394-42 PD-Rx 42 tablets — AB FDA listed —
Terbinafine 250 mg 76282-0209-01 Exelan 100 tablets — — FDA listed —
terbinafine hydrochloride 250 mg 82804-0220-30 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

🏛️
2010
On the market since
Dec 2010
📍
2026
Currently FDA-listed
16 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.

What it looks like

Color White
ShapeOval
ImprintB;526
Size14 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 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 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 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 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.

5 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.

Manufacturer & labeler

LabelerProficient Rx LP
Application holderBRECKENRIDGE PHARMACEUTICAL INC
FDA applicationANDA077714 (ANDA)
Labeler code71205
First marketedDec 2010
Product typeHuman Prescription Drug
Portfolio1,729 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 76 words ▾

1. INDICATIONS AND USAGE Terbinafine tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). Prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (KOH) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis.

Terbinafine tablets are an allylamine antifungal indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). ( 1 )

⏱️ Dosage and Administration 131 words ▾

2. DOSAGE AND ADMINISTRATION • Prior to administering, evaluate patients for evidence of chronic or active liver disease. ( 2.1 ) • Fingernail onychomycosis: One 250 mg tablet, once daily for 6 weeks. ( 2.2 ) • Toenail onychomycosis: One 250 mg tablet, once daily for 12 weeks. ( 2.2 )

2.1Assessment Prior to Initiation Before administering Terbinafine tablets, evaluate patients for evidence of chronic or active liver disease [see Contraindications (4) and Warnings and Precautions (5.1) ] .

2.2Dosage Fingernail onychomycosis: One 250 mg tablet once daily for 6 weeks. Toenail onychomycosis: One 250 mg tablet once daily for 12 weeks. The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for outgrowth of healthy nail.

💊 Dosage Forms and Strengths 31 words ▾

3. DOSAGE FORMS AND STRENGTHS Tablet, 250 mg, white, oblong, unscored, debossed "B" and "526" on one side and plain on the other side • Tablet, 250 mg ( 3 )

⛔ Contraindications 66 words ▾

4. CONTRAINDICATIONS Terbinafine tablets are contraindicated in patients with: • History of allergic reaction to oral terbinafine because of the risk of anaphylaxis [see Adverse Reactions (6.2) ] • Chronic or active liver disease [see Warnings and Precautions (5.1) ] • History of allergic reaction to oral terbinafine because of the risk of anaphylaxis. ( 4 ) • Chronic or active liver disease. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5. WARNINGS AND PRECAUTIONS • Liver failure, sometimes leading to liver transplant or death, has occurred with the use of oral terbinafine. Obtain pretreatment serum transaminases.

Prior to initiating treatment and periodically during therapy, assess liver function tests. Discontinue Terbinafine tablets if liver injury develops. ( 5.1 ) • Taste disturbance, including taste loss, has been reported with the use of Terbinafine tablets.

Taste disturbance can be severe, may be prolonged, or may be permanent. Discontinue Terbinafine tablets if taste disturbance occurs. ( 5.2 ) • Smell disturbance, including loss of smell, has been reported with the use of Terbinafine tablets.

Smell disturbance may be prolonged, or may be permanent. Discontinue Terbinafine tablets if smell disturbance occurs. ( 5.3 ) • Depressive symptoms have been reported with terbinafine use.

Prescribers should be alert to the development of depressive symptoms. ( 5.4 ) • Severe neutropenia has been reported. If the neutrophil count is less than or equal to 1000 cells/mm 3 , Terbinafine tablets should be discontinued.

( 5.5 ) • Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, bullous dermatitis, and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome have been reported with oral terbinafine use. If signs or symptoms of drug reaction occur, treatment with Terbinafine tablets should be discontinued. ( 5.6 )

5.1Hepatotoxicity Terbinafine tablets are contraindicated for patients with chronic or active liver disease. Before prescribing Terbinafine tablets, perform liver function tests because hepatotoxicity may occur in patients with and without preexisting liver disease. Cases of liver failure, some leading to liver transplant or death, have occurred with the use of Terbinafine tablets in individuals with and without preexisting liver disease.

In the majority of liver cases reported in association with use of Terbinafine tablets, the patients had serious underlying systemic conditions. The severity of hepatic events and/or their outcome may be worse in patients with active or chronic liver disease. Periodic monitoring of liver function tests is recommended.

Discontinue Terbinafine tablets if biochemical or clinical evidence of liver injury develops. Warn patients prescribed Terbinafine tablets and/or their caregivers to report immediately to their healthcare providers any symptoms or signs of persistent nausea, anorexia, fatigue, vomiting, right upper abdominal pain or jaundice, dark urine, or pale stools. Advise patients with these symptoms to discontinue taking oral terbinafine, and immediately evaluate the patient's liver function.

5.2Taste Disturbance Including Loss of Taste Taste disturbance, including taste loss, has been reported with the use of Terbinafine tablets. It can be severe enough to result in decreased food intake, weight loss, anxiety, and depressive symptoms. Taste disturbance may resolve within several weeks after discontinuation of treatment, but may be prolonged (greater than 1 year), or may be permanent.

If symptoms of a taste disturbance occur, Terbinafine tablets should be discontinued.

5.3Smell Disturbance Including Loss of Smell Smell disturbance, including loss of smell, has been reported with the use of Terbinafine tablets. Smell disturbance may resolve after discontinuation of treatment, but may be prolonged (greater than 1 year), or may be permanent. If symptoms of a smell disturbance occur, Terbinafine tablets should be discontinued.

5.4Depressive Symptoms Depressive symptoms have occurred during postmarketing use of Terbinafine tablets. Prescribers should be alert to the development of depressive symptoms, and patients should be instructed to report depressive symptoms to their physician.

5.5Hematologic Effects Transient decreases in absolute lymphocyte counts (ALCs) have been observed in controlled clinical trials. In placebo-controlled trials, 8/465 subjects re… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6. ADVERSE REACTIONS Common (greater than 2% of patients treated with Terbinafine tablets) reported adverse events include headache, diarrhea, rash, dyspepsia, liver enzyme abnormalities, pruritus, taste disturbance, nausea, abdominal pain, and flatulence. ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Breckenridge Pharmaceutical, Inc. at 1-800-367-3395, or go to www.bpirx.com, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most frequently reported adverse events observed in the 3 US/Canadian placebo-controlled trials are listed in the table below. The adverse events reported encompass gastrointestinal symptoms (including diarrhea, dyspepsia, and abdominal pain), liver test abnormalities, rashes, urticaria, pruritus, and taste disturbances.

Changes in the ocular lens and retina have been reported following the use of Terbinafine tablets in controlled trials. The clinical significance of these changes is unknown. In general, the adverse events were mild, transient, and did not lead to discontinuation from study participation.

Adverse Event Discontinuation terbinafine (%) n=465 Placebo (%) n=137 terbinafine (%) n=465 Placebo (%) n=137 Headache 12.9 9.5 0.2

0.0Gastrointestinal Symptoms: Diarrhea 5.6 2.9 0.6

0.0Dyspepsia 4.3 2.9 0.4

0.0Abdominal Pain 2.4 1.5 0.4

0.0Nausea 2.6 2.9 0.2

0.0Flatulence 2.2 2.2 0.0

0.0Dermatological Symptoms: Rash 5.6 2.2 0.9

0.7Pruritus 2.8 1.5 0.2

0.0Urticaria 1.1 0.0 0.0

0.0Liver Enzyme Abnormalities Liver enzyme abnormalities greater than or equal to 2× the upper limit of normal range. 3.3 1.4 0.2

0.0Taste Disturbance 2.8 0.7 0.2

0.0Visual Disturbance 1.1 1.5 0.9 0.0

6.2Postmarketing Experience The following adverse events have been identified during post-approval use of Terbinafine tablets. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Blood and lymphatic system disorders: Pancytopenia, agranulocytosis, severe neutropenia, thrombocytopenia, anemia, thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome [see Warnings and Precautions (5.5 , 5.8) ] Immune system disorders: Serious hypersensitivity reactions e.g., angioedema and allergic reactions (including anaphylaxis), precipitation and exacerbation of cutaneous and systemic lupus erythematosus [see Warnings and Precautions (5.7) ] , serum sickness-like reaction Psychiatric disorders: Anxiety and depressive symptoms independent of taste disturbance have been reported with use of Terbinafine tablets.

In some cases, depressive symptoms have been reported to subside with discontinuance of therapy and to recur with reinstitution of therapy [see Warnings and Precautions (5.4) ] . Nervous system disorders: Cases of taste disturbance, including taste loss, have been reported with the use of Terbinafine tablets. It can be severe enough to result in decreased food intake, weight loss, anxiety, and depressive symptoms.

Cases of smell disturbance, including smell loss, have been reported with the use of Terbinafine tablets [see Warnings and Precautions (5.2 , 5.3) ] . Cases of paresthesia and hypoesthesia have been reported with the use of Terbinafine tablets. Eye disorders: Visual field defects, reduced visual acuity Ear and labyrinth disorders: Hearing impairment, vertigo, tinnitus Vascular disorders: Vasculitis Gastrointestinal disorders: Pancreatitis, vomiting Hepatobiliary disorders: Cases of liver failure some leading to liver transplant or death [see Warnings and Precautions (5.1) ] , idiosyncratic and symptomatic hepatic injury.

Cases of he… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7. DRUG INTERACTIONS Terbinafine is an inhibitor of CYP450 2D6 isozyme and has an effect on metabolism of desipramine. Drug interactions have also been noted with cimetidine, fluconazole, cyclosporine, rifampin, and caffeine. ( 7.1 )

7.1Drug-Drug Interactions In vivo studies have shown that terbinafine is an inhibitor of the CYP450 2D6 isozyme. Drugs predominantly metabolized by the CYP450 2D6 isozyme include the following drug classes: tricyclic antidepressants, selective serotonin reuptake inhibitors, beta-blockers, antiarrhythmics class 1C (e.g., flecainide and propafenone) and monoamine oxidase inhibitors Type B. Coadministration of Terbinafine tablets should be done with careful monitoring and may require a reduction in dose of the 2D6-metabolized drug.

In a study to assess the effects of terbinafine on desipramine in healthy volunteers characterized as normal metabolizers, the administration of terbinafine resulted in a 2-fold increase in C max and a 5-fold increase in area under the curve (AUC). In this study, these effects were shown to persist at the last observation at 4 weeks after discontinuation of Terbinafine tablets. In studies in healthy subjects characterized as extensive metabolizers of dextromethorphan (antitussive drug and CYP2D6 probe substrate), terbinafine increases the dextromethorphan/ dextrorphan metabolite ratio in urine by 16- to 97-fold on average.

Thus, terbinafine may convert extensive CYP2D6 metabolizers to poor metabolizer status. In vitro studies with human liver microsomes showed that terbinafine does not inhibit the metabolism of tolbutamide, ethinylestradiol, ethoxycoumarin, cyclosporine, cisapride and fluvastatin. In vivo drug-drug interaction studies conducted in healthy volunteer subjects showed that terbinafine does not affect the clearance of antipyrine or digoxin.

Terbinafine decreases the clearance of caffeine by 19%. Terbinafine increases the clearance of cyclosporine by 15%. The influence of terbinafine on the pharmacokinetics of fluconazole, cotrimoxazole (trimethoprim and sulfamethoxazole), zidovudine or theophylline was not considered to be clinically significant.

Coadministration of a single dose of fluconazole (100 mg) with a single dose of terbinafine resulted in a 52% and 69% increase in terbinafine C max and AUC, respectively. Fluconazole is an inhibitor of CYP2C9 and CYP3A enzymes. Based on this finding, it is likely that other inhibitors of both CYP2C9 and CYP3A4 (e.g., ketoconazole, amiodarone) may also lead to a substantial increase in the systemic exposure (C max and AUC) of terbinafine when concomitantly administered.

There have been spontaneous reports of increase or decrease in prothrombin times in patients concomitantly taking oral terbinafine and warfarin, however, a causal relationship between Terbinafine tablets and these changes has not been established. Terbinafine clearance is increased 100% by rifampin, a CYP450 enzyme inducer, and decreased 33% by cimetidine, a CYP450 enzyme inhibitor. Terbinafine clearance is unaffected by cyclosporine.

There is no information available from adequate drug-drug interaction studies with the following classes of drugs: oral contraceptives, hormone replacement therapies, hypoglycemics, phenytoins, thiazide diuretics, and calcium channel blockers.

7.2Food Interactions An evaluation of the effect of food on Terbinafine tablets was conducted. An increase of less than 20% of the AUC of terbinafine was observed when Terbinafine tablets were administered with food. Terbinafine tablets can be taken with or without food.

👥 Use in Specific Populations ~2 min read ▾

8. USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Category B There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, and because treatment of onychomycosis can be postponed until after pregnancy is completed, it is recommended that Terbinafine tablets not be initiated during pregnancy. Oral reproduction studies have been performed in rabbits and rats at doses up to 300 mg/kg/day [12× to 23× the maximum recommended human dose (MRHD), in rabbits and rats, respectively, based on body surface area (BSA) comparisons] and have revealed no evidence of impaired fertility or harm to the fetus due to terbinafine.

8.3Nursing Mothers After oral administration, terbinafine is present in breast milk of nursing mothers. The ratio of terbinafine in milk to plasma is 7:1. Treatment with Terbinafine tablets is not recommended in women who are nursing.

8.4Pediatric Use The safety and efficacy of Terbinafine tablets have not been established in pediatric patients with onychomycosis.

8.5Geriatric Use Clinical studies of Terbinafine tablets did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

8.6Renal Impairment In patients with renal impairment (creatinine clearance less than or equal to 50 mL/min), the use of Terbinafine tablets has not been adequately studied.

8.7Hepatic Impairment Terbinafine tablets are contraindicated for patients with chronic or active liver disease [see Contraindications (4) and Warnings and Precautions (5.1) ] . Cases of liver failure, some leading to liver transplant or death, have occurred with the use of Terbinafine tablets in individuals with and without preexisting liver disease. The severity of hepatic events and/or their outcome may be worse in patients with active or chronic liver disease.

🤰 Pregnancy 103 words ▾

8.1Pregnancy Pregnancy Category B There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, and because treatment of onychomycosis can be postponed until after pregnancy is completed, it is recommended that Terbinafine tablets not be initiated during pregnancy. Oral reproduction studies have been performed in rabbits and rats at doses up to 300 mg/kg/day [12× to 23× the maximum recommended human dose (MRHD), in rabbits and rats, respectively, based on body surface area (BSA) comparisons] and have revealed no evidence of impaired fertility or harm to the fetus due to terbinafine.

🧒 Pediatric Use 19 words ▾

8.4Pediatric Use The safety and efficacy of Terbinafine tablets have not been established in pediatric patients with onychomycosis.

🧓 Geriatric Use 85 words ▾

8.5Geriatric Use Clinical studies of Terbinafine tablets did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage 45 words ▾

10. OVERDOSAGE Clinical experience regarding overdose with oral terbinafine is limited. Doses up to 5 grams (20 times the therapeutic daily dose) have been taken without inducing serious adverse reactions. The symptoms of overdose included nausea, vomiting, abdominal pain, dizziness, rash, frequent urination, and headache.

🧬 Clinical Pharmacology ~2 min read ▾

12. CLINICAL PHARMACOLOGY

12.1Mechanism of Action Terbinafine is an allylamine antifungal [see Clinical Pharmacology (12.4) ] .

12.2Pharmacodynamics The pharmacodynamics of Terbinafine tablets is unknown.

12.3Pharmacokinetics Following oral administration, terbinafine is well absorbed (greater than 70%) and the bioavailability of Terbinafine tablets as a result of first-pass metabolism is approximately 40%. Peak plasma concentrations of 1 mcg/mL appear within 2 hours after a single 250 mg dose; the AUC is approximately 4.56 mcg•h/mL. An increase in the AUC of terbinafine of less than 20% is observed when Terbinafine tablets are administered with food.

In plasma, terbinafine is greater than 99% bound to plasma proteins and there are no specific binding sites. At steady-state, in comparison to a single dose, the peak concentration of terbinafine is 25% higher and plasma AUC increases by a factor of 2.5; the increase in plasma AUC is consistent with an effective half-life of ~36 hours. Terbinafine is distributed to the sebum and skin.

A terminal half-life of 200-400 hours may represent the slow elimination of terbinafine from tissues such as skin and adipose. Prior to excretion, terbinafine is extensively metabolized by at least 7 CYP isoenzymes with major contributions from CYP2C9, CYP1A2, CYP3A4, CYP2C8, and CYP2C19. No metabolites have been identified that have antifungal activity similar to terbinafine.

Approximately 70% of the administered dose is eliminated in the urine. In patients with renal impairment (creatinine clearance less than or equal to 50 mL/min) or hepatic cirrhosis, the clearance of terbinafine is decreased by approximately 50% compared to normal volunteers. No effect of gender on the blood levels of terbinafine was detected in clinical trials.

No clinically relevant age-dependent changes in steady-state plasma concentrations of terbinafine have been reported.

12.4Microbiology Terbinafine, an allylamine antifungal, inhibits biosynthesis of ergosterol, an essential component of fungal cell membrane, via inhibition of squalene epoxidase enzyme. This results in fungal cell death primarily due to the increased membrane permeability mediated by the accumulation of high concentrations of squalene but not due to ergosterol deficiency. Depending on the concentration of the drug and the fungal species test in vitro , terbinafine hydrochloride may be fungicidal.

However, the clinical significance of in vitro data is unknown. Terbinafine has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections: Trichophyton mentagrophytes Trichophyton rubrum The following in vitro data are available, but their clinical significance is unknown. In vitro , terbinafine exhibits satisfactory MIC's against most strains of the following microorganisms; however, the safety and efficacy of terbinafine in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials: Candida albicans Epidermophyton floccosum Scopulariopsis brevicaulis

🧬 Mechanism of Action 15 words ▾

12.1Mechanism of Action Terbinafine is an allylamine antifungal [see Clinical Pharmacology (12.4) ] .

📦 How Supplied / Storage and Handling 92 words ▾

16. HOW SUPPLIED/STORAGE AND HANDLING Terbinafine Tablets, USP are supplied as white, oblong, unscored tablets debossed "B" and "526" on one side and plain on the other side. Bottles of 14 tablets NDC 71205-127-14 Bottles of 15 tablets NDC 71205-127-15 Bottles of 30 tablets NDC 71205-127-30 Bottles of 35 tablets NDC 71205-127-35 Bottles of 42 tablets NDC 71205-127-42 Bottles of 45 tablets NDC 71205-127-45 Bottles of 60 tablets NDC 71205-127-60 Bottles of 90 tablets NDC 71205-127-90 Store Terbinafine Tablets, USP at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature].

📦 Storage and Handling 16 words ▾

Store Terbinafine Tablets, USP at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature].

📋 Description 97 words ▾

11. DESCRIPTION Terbinafine Tablets, USP contain the synthetic allylamine antifungal compound terbinafine hydrochloride. Chemically, terbinafine hydrochloride is (E)- N -(6,6-dimethyl-2-hepten-4-ynyl)- N -methyl-1-naphthalenemethanamine hydrochloride.

The empirical formula C 21 H 26 ClN with a molecular weight of 327.90, and the following structural formula: Terbinafine hydrochloride is a white to off-white fine crystalline powder. It is freely soluble in methanol and methylene chloride, soluble in ethanol, and slightly soluble in water. Each tablet contains: Active Ingredients: terbinafine hydrochloride (equivalent to 250 mg base).

Inactive Ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose and sodium starch glycolate Chemical Structure

💬 Information for Patients 214 words ▾

17. PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-Approved Medication Guide. Patients taking Terbinafine tablets should receive the following information and instructions: • Advise patients to immediately report to their physician or get emergency help if they experience any of the following symptoms: hives, mouth sores, blistering and peeling of skin, swelling of face, lips, tongue, or throat, difficulty swallowing or breathing.

Terbinafine tablets treatment should be discontinued. • Advise patients to immediately report to their physician any symptoms of persistent nausea, anorexia, fatigue, vomiting, right upper abdominal pain, jaundice, dark urine, or pale stools. Terbinafine tablets treatment should be discontinued. • Advise patients to report to their physician any signs of taste disturbance, smell disturbance and/or depressive symptoms, fever, skin eruption, lymph node enlargement, erythema, scaling, loss of pigment, and unusual photosensitivity that can result in a rash.

Terbinafine tablets treatment should be discontinued. • Advise patients to minimize exposure to natural and artificial sunlight (tanning beds or UVA/B treatment) while using Terbinafine tablets. • Advise patients that if they forget to take Terbinafine tablets, to take their tablets as soon as they remember, unless it is less than 4 hours before the next dose is due. • Advise patients to call their physician if they take too many Terbinafine tablets.

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE TERBINAFINE (ter' bin a feen) hydrochloride Tablets What is the most important information I should know about Terbinafine tablets? Terbinafine tablets may cause serious side effects, including: • Liver problems that can lead to the need for a liver transplant or death . This can happen in people who have liver problems and in people who have never had liver problems.

Tell your doctor right away if you get any of these symptoms of liver problems: Your doctor should do a blood test to check you for liver problems before you start treatment with Terbinafine tablets. Your doctor may also check you for liver problems during treatment, and tell you to stop taking Terbinafine tablets if you develop liver problems. • nausea • poor appetite • tiredness • vomiting • upper right stomach-area (abdomen) pain • yellowing of your skin or eyes (jaundice) • dark (tea-colored) urine • pale or light colored stools What are Terbinafine tablets?

Terbinafine tablets are a prescription medicine used to treat fungal infections of the fingernails and toenails (onychomycosis). Your doctor should do tests to check you for fungal infection of your nails before you start Terbinafine tablets. It is not known if Terbinafine tablets are safe and effective in children for the treatment of onychomycosis.

Who should not take Terbinafine tablets? Do not take Terbinafine tablets if you: • have had a severe allergic reaction to terbinafine hydrochloride when taken by mouth. • have had liver disease for a long time (chronic) or have active liver disease. What should I tell my doctor before taking Terbinafine tablets?

Before taking Terbinafine tablets, tell your doctor about all of your medical conditions, including if you: • have or had liver problems • have a weakened immune system (immunocompromised) • have lupus (an autoimmune disease) • are pregnant or plan to become pregnant. It is not known if Terbinafine tablets will harm your unborn baby. You should not start taking Terbinafine tablets during pregnancy. • are breastfeeding or plan to breastfeed.

Terbinafine passes into your breast milk and may harm your baby. You should not breastfeed while taking Terbinafine tablets. Talk to your doctor about the best way to feed your baby if you take Terbinafine tablets.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Terbinafine tablets may affect the way other medicines work and other medicines may affect how Terbinafine tablets work. How should I take Terbinafine tablets? • Take Terbinafine tablets exactly as your doctor tells you to take it. • Terbinafine tablets come as a tablet that you take by mouth. • Terbinafine tablets are usually taken: • 1 time each day for 6 weeks to treat fungal infections of your fingernail, or • 1 time each day for 12 weeks to treat fungal infections of your toenail • Terbinafine tablets can be taken with or without food. • If you miss a dose of Terbinafine tablets, take it as soon as you remember.

If it is less than 4 hours before your next dose, skip the missed dose. Just take the next dose at your regular time. • If you take too many Terbinafine tablets, call your doctor. You may have the following symptoms: • nausea • stomach-area (abdomen) pain • frequent urination • rash • headache • vomiting • dizziness What should I avoid while taking Terbinafine tablets?

Avoid sunlight. Terbinafine tablets can make your skin sensitive to the sun and the light from sunlamps and tanning beds. You can get a severe sunburn.

Use sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight. Talk to your doctor if you get sunburn. What are the possible side effects of Terbinafine tablets?

Terbinafine tablets may cause serious side effects, including: • See "Error! Hyperlink reference not valid." • Change in your sense of taste or loss of taste is common with Terbinafine tablets, but can also be severe. This may improve… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 37 words ▾

8.3Nursing Mothers After oral administration, terbinafine is present in breast milk of nursing mothers. The ratio of terbinafine in milk to plasma is 7:1. Treatment with Terbinafine tablets is not recommended in women who are nursing.

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics Following oral administration, terbinafine is well absorbed (greater than 70%) and the bioavailability of Terbinafine tablets as a result of first-pass metabolism is approximately 40%. Peak plasma concentrations of 1 mcg/mL appear within 2 hours after a single 250 mg dose; the AUC is approximately 4.56 mcg•h/mL. An increase in the AUC of terbinafine of less than 20% is observed when Terbinafine tablets are administered with food.

In plasma, terbinafine is greater than 99% bound to plasma proteins and there are no specific binding sites. At steady-state, in comparison to a single dose, the peak concentration of terbinafine is 25% higher and plasma AUC increases by a factor of 2.5; the increase in plasma AUC is consistent with an effective half-life of ~36 hours. Terbinafine is distributed to the sebum and skin.

A terminal half-life of 200-400 hours may represent the slow elimination of terbinafine from tissues such as skin and adipose. Prior to excretion, terbinafine is extensively metabolized by at least 7 CYP isoenzymes with major contributions from CYP2C9, CYP1A2, CYP3A4, CYP2C8, and CYP2C19. No metabolites have been identified that have antifungal activity similar to terbinafine.

Approximately 70% of the administered dose is eliminated in the urine. In patients with renal impairment (creatinine clearance less than or equal to 50 mL/min) or hepatic cirrhosis, the clearance of terbinafine is decreased by approximately 50% compared to normal volunteers. No effect of gender on the blood levels of terbinafine was detected in clinical trials.

No clinically relevant age-dependent changes in steady-state plasma concentrations of terbinafine have been reported.

🧬 Pharmacodynamics 9 words ▾

12.2Pharmacodynamics The pharmacodynamics of Terbinafine tablets is unknown.

🔬 Clinical Studies ~1 min read ▾

14. CLINICAL STUDIES The efficacy of Terbinafine tablets in the treatment of onychomycosis is illustrated by the response of subjects with toenail and/or fingernail infections who participated in 3 US/Canadian placebo-controlled clinical trials. Results of the first toenail trial, as assessed at week 48 (12 weeks of treatment with 36 weeks follow-up after completion of therapy), demonstrated mycological cure, defined as simultaneous occurrence of negative KOH plus negative culture, in 70% of subjects.

Fifty-nine percent (59%) of subjects experienced effective treatment (mycological cure plus 0% nail involvement or greater than 5mm of new unaffected nail growth); 38% of subjects demonstrated mycological cure plus clinical cure (0% nail involvement). In a second toenail trial of dermatophytic onychomycosis, in which nondermatophytes were also cultured, similar efficacy against the dermatophytes was demonstrated. The pathogenic role of the nondermatophytes cultured in the presence of dermatophytic onychomycosis has not been established.

The clinical significance of this association is unknown. Results of the fingernail trial, as assessed at week 24 (6 weeks of treatment with 18 weeks follow-up after completion of therapy), demonstrated mycological cure in 79% of subjects, effective treatment in 75% of the subjects, and mycological cure plus clinical cure in 59% of the subjects. The mean time to overall success was approximately 10 months for the first toenail trial and 4 months for the fingernail trial.

In the first toenail trial, for subjects evaluated at least 6 months after achieving clinical cure and at least 1 year after completing therapy with Terbinafine tablets, the clinical relapse rate was approximately 15%.

🧪 Nonclinical Toxicology ~1 min read ▾

13. NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a 28-month oral carcinogenicity study in rats, an increase in the incidence of liver tumors was observed in males at the highest dose tested, 69 mg/kg/day (2× the MRHD based on AUC comparisons of the parent terbinafine); however, even though dose-limiting toxicity was not achieved at the highest tested dose, higher doses were not tested. The results of a variety of in vitro (mutations in E. coli and S. typhimurium , DNA repair in rat hepatocytes, mutagenicity in Chinese hamster fibroblasts, chromosome aberration, and sister chromatid exchanges in Chinese hamster lung cells), and in vivo (chromosome aberration in Chinese hamsters, micronucleus test in mice) genotoxicity tests gave no evidence of a mutagenic or clastogenic potential.

Oral reproduction studies in rats at doses up to 300 mg/kg/day (approximately 12× the MRHD based on BSA comparisons) did not reveal any specific effects on fertility or other reproductive parameters. Intravaginal application of terbinafine hydrochloride at 150 mg/day in pregnant rabbits did not increase the incidence of abortions or premature deliveries nor affect fetal parameters.

13.2Animal Toxicology and/or Pharmacology A wide range of in vivo studies in mice, rats, dogs, and monkeys, and in vitro studies using rat, monkey, and human hepatocytes suggest that peroxisome proliferation in the liver is a rat-specific finding. However, other effects, including increased liver weights and APTT, occurred in dogs and monkeys at doses giving C ss trough levels of the parent terbinafine 2-3× those seen in humans at the MRHD. Higher doses were not tested.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 178 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a 28-month oral carcinogenicity study in rats, an increase in the incidence of liver tumors was observed in males at the highest dose tested, 69 mg/kg/day (2× the MRHD based on AUC comparisons of the parent terbinafine); however, even though dose-limiting toxicity was not achieved at the highest tested dose, higher doses were not tested. The results of a variety of in vitro (mutations in E. coli and S. typhimurium , DNA repair in rat hepatocytes, mutagenicity in Chinese hamster fibroblasts, chromosome aberration, and sister chromatid exchanges in Chinese hamster lung cells), and in vivo (chromosome aberration in Chinese hamsters, micronucleus test in mice) genotoxicity tests gave no evidence of a mutagenic or clastogenic potential.

Oral reproduction studies in rats at doses up to 300 mg/kg/day (approximately 12× the MRHD based on BSA comparisons) did not reveal any specific effects on fertility or other reproductive parameters. Intravaginal application of terbinafine hydrochloride at 150 mg/day in pregnant rabbits did not increase the incidence of abortions or premature deliveries nor affect fetal parameters.

📄 Recent Major Changes 33 words ▾

Dosage and Administration: Assessment Prior to Initiation ( 2.1 ) 8/2016 Contraindications ( 4 ) 8/2016 Warnings and Precautions: Hepatotoxicty ( 5.1 ) 8/2016 Warnings and Precautions: Thrombotic Microangiopathy ( 5.8 ) 1/2017

📄 Package Label / Principal Display Panel 31 words ▾

PRINCIPAL DISPLAY PANEL - 250 mg Tablet Bottle Label NDC 71205-127-14 Terbinafine Tablets, USP 250 mg PHARMACIST: Dispense the Medication Guide provided separately to each patient. Rx only 14 Tablets 71205-127-14

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

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
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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

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 Proficient Rx LP. 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 7 other package presentations of this same product, including 14 tablets (71205-0127-14), 15 tablets (71205-0127-15), 30 tablets (71205-0127-30). 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?
Proficient Rx LP 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.
← 71205-0126-10 · Proficient 71205-0128-30 · Proficient →
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.