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Emverm mebendazole 100 mg Tablet, Chewable, 1 tablet — NDC 64896-0669-30 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Emverm mebendazole 100 mg Tablet, Chewable, 1 tablet — NDC 64896-669-30 (Billing 64896-0669-30)

by Amneal Pharmaceuticals LLC · 1 BLISTER PACK in 1 CARTON / 1 TABLET, CHEWABLE in 1 BLISTER PACK

This is a package of 1 tablet of Emverm mebendazole 100 mg Tablet, Chewable from Amneal Pharmaceuticals LLC, no longer marketed, no longer in the FDA NDC Directory; retail pharmacies pay about $712.47 per tablet (NADAC). It is this product's only package size.

NDC 64896-0669-30
🏷️ FDA NDC (as labeled) 64896-669-30 billing pads the product segment with a zero
Rx only Generic Discontinued Non-controlled ⚠ Inactivated by FDA ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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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 64896-669-30 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
64896 labeler · 669 product · 30 package
Billing quantity
1 EA per package
Barcode (UPC-A, from the NDC)
3 6489666930 8
Medicaid fills, this package
13,051 prescriptions in the last four reported quarters
FDA record last changed
Jul 17, 2026
⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2027. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 64896-669-30
Product NDC 64896-669
11-digit billing NDC 64896066930
NCPDP billing unit EA — each (per item)
Application # ANDA073580
SPL Set ID a8c46363-f739-4f6e-bca8-1ce5e8d3f78d
Established class (EPC) Anthelmintic
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2027)
Route ORAL
Dosage form TABLET, CHEWABLE
Substance MEBENDAZOLE

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

GPI-14 15000010000505
GCN Seq No 009607
GCN 43181
HICL code 004167
Ingredient (HICL) Mebendazole
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W4
Therapeutic class — intermediate (HIC2) Antiparasitics
HIC3 code W4L
Therapeutic class — specific (HIC3) Anthelmintics
AHFS code 08:08.00.00
AHFS class Anthelmintics
FDB label name EMVERM 100 MG TABLET CHEW
FDB brand name Emverm
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 009607
  • GCN: 43181
  • GPI-14 (Medi-Span): 15000010000505
  • HICL (First Databank): 004167
  • AHFS class code: 08:08.00.00
Why two NDCs? The FDA registers this code as 64896-669-30 — 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 → 64896-0669-30. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Label name EMVERM 100 MG TABLET CHEW Ingredient Mebendazole
📖 What it is MedlinePlus · NLM

Mebendazole is used to treat several types of worm infections. Mebendazole (Vermox) is used to treat roundworm and whipworm infections. Mebendazole (Emverm) is used to treat pinworm, whipworm, roundworm, and hookworm infections. Mebendazole is in a class of medications called anthelmintics. It works by killing the worms.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats worm infections in the gut. Emverm covers hookworm, roundworm, pinworm and whipworm in people 2 and older. Vermox Chewable covers roundworm and whipworm in people 1 and o...
  • Take it by mouth exactly as prescribed. With Emverm, you can chew it, swallow it, or crush it into food. With Vermox Chewable, chew it completely and don't swallow it whole. No fas...
  • Most people have little trouble. Possible effects include stomach pain, nausea, vomiting, diarrhea, gas, loss of appetite and rash. Call your doctor for severe skin reactions, swel...
  • Avoid it. Serious skin reactions, including Stevens-Johnson syndrome, have been reported when the two are used together. Tell me or your doctor about every medicine you take.
📖 Read our full Mebendazole guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $712.469 $712.47 / 1 tablet
Medicaid paysCMS SDUD · 12 mo $706.23 $706.23 / 1 tablet
Medicare drug plans payPart D · Q2 2026 $707.75 $707.75 / 1 tablet
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Feb 2024 May 2026 Sep 2026 $712.469 $490.031
▲ Up 45% over the last 12 months.
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
64896-0669-30 You're viewing this Main listing 1 BLISTER PACK in 1 CARTON / 1 TABLET, CHEWABLE in 1 BLISTER PACK 2016-02-15 — Inactivated by FDA

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Emverm 100 mgthis 64896-0669-30 Amneal 1 tablet $712.469 — Discontinued —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color orange
ShapeRound
Imprintap;107
Size10 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.

🧪 Avoiding an ingredient? See Mebendazole 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • 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 SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • 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.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.

9 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

LabelerAmneal Pharmaceuticals LLC
Application holderIMPAX LABORATORIES INC
FDA applicationANDA073580 (ANDA)
Labeler code64896
Product typeHuman Prescription Drug
Portfolio490 products on file

More NDCs from Amneal Pharmaceuticals LLC labeler code 64896

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 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 81 words ▾

1 INDICATIONS AND USAGE EMVERM ® is indicated for the treatment of patients two years of age and older with gastrointestinal infections caused by Ancylostoma duodenale (hookworm), Ascaris lumbricoides (roundworm), Enterobius vermicularis (pinworm), Necator americanus (hookworm), and Trichuris trichiura (whipworm). EMVERM ® is an anthelmintic indicated for the treatment of patients two years of age and older with gastrointestinal infections caused by: Ancylostoma duodenale (hookworm), Ascaris lumbricoides (roundworm), Enterobius vermicularis (pinworm), Necator americanus (hookworm), and Trichuris trichiura (whipworm), ( 1 ).

⏱️ Dosage and Administration 182 words ▾

2 DOSAGE AND ADMINISTRATION The recommended dosage for EMVERM ® is described in Table 1 below. The same dosage schedule applies to adults and pediatric patients two years of age and older. The tablet may be chewed, swallowed, or crushed and mixed with food.

Table 1: Dosage of EMVERM in Adult and Pediatric Patients (two years of age and older) Pinworm (enterobiasis) Whipworm (trichuriasis) Roundworm (ascariasis) Hookworm Dose 1 tablet once 1 tablet morning and evening for 3 consecutive days 1 tablet morning and evening for 3 consecutive days 1 tablet morning and evening for 3 consecutive days If the patient is not cured three weeks after treatment, a second course of treatment is advised. No special procedures, such as fasting or purging, are required. Adults and Pediatrics : The tablet may be chewed, swallowed, or crushed and mixed with food ( 2 ).

Pinworm (enterobiasis) Whipworm (trichuriasis) Roundworm (ascariasis) Hookworm Dose 1 tablet once 1 tablet morning and evening for 3 consecutive days 1 tablet morning and evening for 3 consecutive days 1 tablet morning and evening for 3 consecutive days

💊 Dosage Forms and Strengths 37 words ▾

3 DOSAGE FORMS AND STRENGTHS EMVERM ® (mebendazole) Chewable Tablet, USP: 100 mg, round, light peach-colored, unscored, debossed “ap” above “107” on one side and plain on the other side. Chewable Tablet: 100 mg ( 3 )

⛔ Contraindications 32 words ▾

4 CONTRAINDICATIONS EMVERM ® is contraindicated in persons with a known hypersensitivity to the drug or its excipients. Patients with a known hypersensitivity to the drug or its excipients ( 4 )

⚠️ Warnings and Cautions 208 words ▾

5 WARNINGS AND PRECAUTIONS Risk of Convulsions: Convulsions in infants below the age of 1 year have been reported (5.1). Hematologic Effects: Neutropenia and agranulocytosis have been reported in patients receiving mebendazole at higher doses and for prolonged duration. Monitor blood counts in these patients (5.2).

Metronidazole and Serious Skin Reactions: Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) have been reported with the concomitant use of mebendazole and metronidazole. Avoid concomitant use of mebendazole and metronidazole (5.3).

5.1Risk of Convulsions Although EMVERM ® is approved for use in children two years of age and older, convulsions have been reported in infants below the age of 1 year during post-marketing experience with mebendazole, including EMVERM ® [see Adverse Reactions ( 6.2 ) and Use in Specific Populations ( 8.4 )] .

5.2Hematologic Effects Agranulocytosis and neutropenia have been reported with mebendazole use at higher doses and for more prolonged durations than is recommended for the treatment of soil-transmitted helminth infections. Monitor blood counts if EMVERM ® is used at higher doses or for prolonged duration.

5.3Metronidazole Drug Interaction and Serious Skin Reactions Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) have been reported with the concomitant use of mebendazole and metronidazole. Avoid concomitant use of mebendazole, including EMVERM ® and metronidazole.

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS Adverse reactions reported in clinical trials were anorexia, abdominal pain, diarrhea, flatulence, nausea, vomiting and rash ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Studies Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed 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 safety of mebendazole was evaluated in 6276 subjects who participated in 39 clinical trials for treatment of single or mixed parasitic infections of the gastrointestinal tract. In these trials, the formulations, dosages and duration of mebendazole treatment varied.

Adverse reactions reported in mebendazole-treated subjects from the 39 clinical trials are shown in Table 2 below. Table 2: Adverse Reactions Reported in Mebendazole-treated Subjects from 39 Clinical Trials * Adverse Reaction(s) Gastrointestinal Disorders Anorexia Abdominal Pain Diarrhea Flatulence Nausea Vomiting Skin and Subcutaneous Tissue Disorders Rash *Includes mebendazole formulations, dosages and treatment duration other than EMVERM ® 100 mg tablet

6.2Postmarketing Experience The following adverse reactions have been identified in adult and pediatric patients postmarketing with mebendazole formulations and dosages other than the EMVERM ® 100 mg chewable tablet. Because these reactions 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. Table 3: Adverse Reactions Identified During Postmarketing Experience with Mebendazole * Adverse Reaction(s) Blood and Lymphatic System Disorders Agranulocytosis, Neutropenia Immune System Disorders Hypersensitivity including anaphylactic reactions Nervous System Disorders Convulsions, Dizziness Hepatobiliary Disorders Hepatitis, Abnormal liver tests Renal and Urinary Disorders Glomerulonephritis Skin and Subcutaneous Tissue Disorders Toxic epidermal necrolysis, Stevens-Johnson syndrome, Exanthema, Angioedema, Urticaria, Alopecia *Includes mebendazole formulations, dosages and treatment duration other than EMVERM ® 100 mg chewable tablets

🔄 Drug Interactions 22 words ▾

7 DRUG INTERACTIONS Concomitant use of mebendazole, including EMVERM ® , and metronidazole should be avoided [see Warnings and Precautions (5.3)] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary The available published literature on mebendazole use in pregnant women has not reported a clear association between mebendazole and a potential risk of major birth defects or miscarriages [see Data]. There are risks to the mother and fetus associated with untreated helminthic infection during pregnancy [see Clinical Considerations] . In animal reproduction studies, adverse developmental effects (i.e., skeletal malformations, soft tissue malformations, decreased pup weight, embryolethality) were observed when mebendazole was administered to pregnant rats during the period of organogenesis at single oral doses as low as 10 mg/kg (approximately 0.5-fold the total daily maximum recommended human dose [MRHD]).

Maternal toxicity was present at the highest of these doses [see Data]. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risks Untreated soil transmitted helminth infections in pregnancy are associated with adverse outcomes including maternal iron deficiency anemia, low birth weight, neonatal and maternal death. Data Human Data Several published studies, including prospective pregnancy registries, case-control, retrospective cohort, and randomized controlled studies, have reported no association between mebendazole use and a potential risk of major birth defects or miscarriage.

Overall, these studies did not identify a specific pattern or frequency of major birth defects with mebendazole use. However, these studies cannot definitely establish the absence of any mebendazole-associated risk because of methodological limitations, including recall bias, confounding factors and, in some cases, small sample size or exclusion of first trimester mebendazole exposures. Animal Data Embryo-fetal developmental toxicity studies in rats revealed no adverse effects on dams or their progeny at doses up to 2.5 mg/kg/day on gestation days 6–15 (the period of organogenesis).

Dosing at ≥10 mg/kg/day resulted in a lowered body weight gain and a decreased pregnancy rate. Maternal toxicity, including body weight loss in one animal and maternal death in 11 of 20 animals, was seen at 40 mg/kg/day. At 10 mg/kg/day, increased embryo-fetal resorption (100% were resorbed at 40 mg/kg/day), decreased pup weight and increased incidence of malformations (primarily skeletal) were observed.

Mebendazole was also embryotoxic and teratogenic in pregnant rats at single oral doses during organogenesis as low as 10 mg/kg (approximately 0.5-fold the total daily MRHD, based on mg/m 2 ). In embryo-fetal developmental toxicity studies in mice dosed on gestation days 6–15, doses of 10 mg/kg/day and higher resulted in decreased body weight gain at 10 and 40 mg/kg/day and a higher mortality rate at 40 mg/kg/day. At doses of 10 mg/kg/day (approximately 0.2-fold the total daily MRHD, based on mg/m 2 ) and higher, embryo-fetal resorption increased (100% at 40 mg/kg) and fetal malformations, including skeletal, cranial, and soft tissue anomalies, were present.

Dosing of hamsters and rabbits did not result in embryotoxicity or teratogenicity at doses up to 40 mg/kg/day (1.6 to 3.9-fold the total daily MRHD, based on mg/m 2 ). In a peri- and post-natal toxicity study in rats, mebendazole did not adversely affect dams or their progeny at 20 mg/kg/day. At 40 mg/kg (1.9-fold the total daily MRHD, based on mg/m 2 ), a reduction of the number of live pups was observed and there was no survival at weaning.

No abnormalities were found on gross and radiographic examination of pups at birth.

8.2Lactation Risk Summary Limited data from case re… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary The available published literature on mebendazole use in pregnant women has not reported a clear association between mebendazole and a potential risk of major birth defects or miscarriages [see Data]. There are risks to the mother and fetus associated with untreated helminthic infection during pregnancy [see Clinical Considerations] . In animal reproduction studies, adverse developmental effects (i.e., skeletal malformations, soft tissue malformations, decreased pup weight, embryolethality) were observed when mebendazole was administered to pregnant rats during the period of organogenesis at single oral doses as low as 10 mg/kg (approximately 0.5-fold the total daily maximum recommended human dose [MRHD]).

Maternal toxicity was present at the highest of these doses [see Data]. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risks Untreated soil transmitted helminth infections in pregnancy are associated with adverse outcomes including maternal iron deficiency anemia, low birth weight, neonatal and maternal death. Data Human Data Several published studies, including prospective pregnancy registries, case-control, retrospective cohort, and randomized controlled studies, have reported no association between mebendazole use and a potential risk of major birth defects or miscarriage.

Overall, these studies did not identify a specific pattern or frequency of major birth defects with mebendazole use. However, these studies cannot definitely establish the absence of any mebendazole-associated risk because of methodological limitations, including recall bias, confounding factors and, in some cases, small sample size or exclusion of first trimester mebendazole exposures. Animal Data Embryo-fetal developmental toxicity studies in rats revealed no adverse effects on dams or their progeny at doses up to 2.5 mg/kg/day on gestation days 6–15 (the period of organogenesis).

Dosing at ≥10 mg/kg/day resulted in a lowered body weight gain and a decreased pregnancy rate. Maternal toxicity, including body weight loss in one animal and maternal death in 11 of 20 animals, was seen at 40 mg/kg/day. At 10 mg/kg/day, increased embryo-fetal resorption (100% were resorbed at 40 mg/kg/day), decreased pup weight and increased incidence of malformations (primarily skeletal) were observed.

Mebendazole was also embryotoxic and teratogenic in pregnant rats at single oral doses during organogenesis as low as 10 mg/kg (approximately 0.5-fold the total daily MRHD, based on mg/m 2 ). In embryo-fetal developmental toxicity studies in mice dosed on gestation days 6–15, doses of 10 mg/kg/day and higher resulted in decreased body weight gain at 10 and 40 mg/kg/day and a higher mortality rate at 40 mg/kg/day. At doses of 10 mg/kg/day (approximately 0.2-fold the total daily MRHD, based on mg/m 2 ) and higher, embryo-fetal resorption increased (100% at 40 mg/kg) and fetal malformations, including skeletal, cranial, and soft tissue anomalies, were present.

Dosing of hamsters and rabbits did not result in embryotoxicity or teratogenicity at doses up to 40 mg/kg/day (1.6 to 3.9-fold the total daily MRHD, based on mg/m 2 ). In a peri- and post-natal toxicity study in rats, mebendazole did not adversely affect dams or their progeny at 20 mg/kg/day. At 40 mg/kg (1.9-fold the total daily MRHD, based on mg/m 2 ), a reduction of the number of live pups was observed and there was no survival at weaning.

No abnormalities were found on gross and radiographic examination of pups at birth.

🧒 Pediatric Use 51 words ▾

8.4Pediatric Use The safety and effectiveness of EMVERM ® 100 mg chewable tablets has not been established in pediatric patients less than two years of age. Convulsions have been reported with mebendazole use in children less than one year of age [see Warnings and Precautions (5.1) and Adverse Reactions (6.2)].

🧓 Geriatric Use 27 words ▾

8.5Geriatric Use Clinical studies of mebendazole did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects.

🆘 Overdosage 52 words ▾

10 OVERDOSAGE In patients treated at dosages substantially higher than recommended or for prolonged periods of time, the following adverse reactions have been reported: alopecia, reversible transaminase elevations, hepatitis, agranulocytosis, neutropenia, and glomerulonephritis. Symptoms and signs In the event of accidental overdose, gastrointestinal signs/symptoms may occur. Treatment There is no specific antidote.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Mebendazole, a benzimidazole, is an anthelmintic drug [see Microbiology (12.4)] .

12.3Pharmacokinetics Absorption Following oral administration of mebendazole, the majority of the dose remains in the gastrointestinal tract where it exerts an anthelmintic effect locally. Following administration of 100 mg twice daily for three consecutive days, plasma concentrations of EMVERM ® (mebendazole) and its primary metabolite, the 2-amine hydrolyzed metabolite, do not exceed 0.03 mcg/mL and 0.09 mcg/mL, respectively. Dosing with a high fat meal increases the bioavailability of mebendazole, although the overall effect of food on the amount of drug remaining in the gastrointestinal tract is not expected to be substantial.

Distribution The plasma protein binding of mebendazole is 90 to 95%. The volume of distribution is 1 to 2 L/kg, indicating that absorbed mebendazole penetrates areas outside the vascular space. Metabolism Orally administered mebendazole is extensively metabolized primarily by the liver.

Plasma concentrations of its major metabolites (hydrolyzed and reduced forms of mebendazole) are higher than those of mebendazole. All metabolites are devoid of anthelmintic activity. Impaired hepatic function, impaired metabolism, or impaired biliary elimination may lead to higher plasma concentrations of mebendazole.

Excretion Mebendazole, the conjugated forms of mebendazole, and its metabolites likely undergo some degree of enterohepatic recirculation. The apparent elimination half-life after an oral dose ranges from 3 to 6 hours in most patients. Less than 2% of orally administered mebendazole is excreted in urine and the remainder in the feces as unchanged drug or its metabolites.

12.4Microbiology Mechanism of Action Mebendazole interferes with cellular tubulin formation in the helminth and causes ultrastructural degenerative changes in its intestine. As a result, its glucose uptake and the digestive and reproductive functions are disrupted, leading to immobilization, inhibition of egg production and death of the helminth. Antimicrobial Activity Mebendazole is active against: Ancylostoma duodenale Ascaris lumbricoides Enterobius vermicularis Necator americanus Trichuris trichiura Resistance There is a potential for development of resistance to mebendazole.

The mechanism of resistance to mebendazole is likely due to changes of beta-tubulin protein, which reduces binding of mebendazole to beta-tubulin; however, the clinical significance of this is not known.

🧬 Mechanism of Action 15 words ▾

12.1Mechanism of Action Mebendazole, a benzimidazole, is an anthelmintic drug [see Microbiology (12.4)] .

📦 How Supplied / Storage and Handling 59 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING EMVERM ® (mebendazole) Chewable Tablet, USP is available as a 100 mg, round, light peach-colored, unscored, debossed “ap” above “107” on one side and plain on the other side. They are supplied as follows: Blister package of 1 tablet NDC 64896-669-30 Store at 68° to 77°F (20° to 25°C) [See USP Controlled Room Temperature].

📋 Description 109 words ▾

11 DESCRIPTION EMVERM ® (mebendazole) is an orally administered, synthetic anthelmintic available as chewable tablets, each containing 100 mg of mebendazole, USP. Inactive ingredients are: microcrystalline cellulose, corn starch, anhydrous lactose NF, sodium starch glycolate, magnesium stearate, stearic acid, sodium lauryl sulfate, sodium saccharin, and FD&C Yellow #6. Chemically, mebendazole is methyl 5-benzoylbenzimidazole-2-carbamate with a molecular formula of C 16 H 13 N 3 O 3 and the following structural formula: Mebendazole, USP is a white to slightly yellow powder with a molecular weight of 295.29.

It is less than 0.05% soluble in water, dilute mineral acid solutions, alcohol, ether and chloroform, but is soluble in formic acid. 1

💬 Information for Patients 56 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Advise patients that: Taking EMVERM ® and metronidazole together may cause serious skin reactions and should be avoided [see Warning and Precautions ( 5.3 )]. EMVERM ® can be taken with or without food [see Dosage and Administration ( 2 )].

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics Absorption Following oral administration of mebendazole, the majority of the dose remains in the gastrointestinal tract where it exerts an anthelmintic effect locally. Following administration of 100 mg twice daily for three consecutive days, plasma concentrations of EMVERM ® (mebendazole) and its primary metabolite, the 2-amine hydrolyzed metabolite, do not exceed 0.03 mcg/mL and 0.09 mcg/mL, respectively. Dosing with a high fat meal increases the bioavailability of mebendazole, although the overall effect of food on the amount of drug remaining in the gastrointestinal tract is not expected to be substantial.

Distribution The plasma protein binding of mebendazole is 90 to 95%. The volume of distribution is 1 to 2 L/kg, indicating that absorbed mebendazole penetrates areas outside the vascular space. Metabolism Orally administered mebendazole is extensively metabolized primarily by the liver.

Plasma concentrations of its major metabolites (hydrolyzed and reduced forms of mebendazole) are higher than those of mebendazole. All metabolites are devoid of anthelmintic activity. Impaired hepatic function, impaired metabolism, or impaired biliary elimination may lead to higher plasma concentrations of mebendazole.

Excretion Mebendazole, the conjugated forms of mebendazole, and its metabolites likely undergo some degree of enterohepatic recirculation. The apparent elimination half-life after an oral dose ranges from 3 to 6 hours in most patients. Less than 2% of orally administered mebendazole is excreted in urine and the remainder in the feces as unchanged drug or its metabolites.

🔬 Clinical Studies 47 words ▾

14 CLINICAL STUDIES Efficacy rates derived from various studies are shown in Table 4 below: Table 4: Mean Cure Rates and Egg Reductions from Clinical Studies Pinworm (enterobiasis) Whipworm (trichuriasis) Roundworm (ascariasis) Hookworm Cure rates mean 95% 68% 98% 96% Egg reduction mean - 93% 99% 99%

🧪 Nonclinical Toxicology 159 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In carcinogenicity tests of mebendazole in mice and rats, no carcinogenic effects were seen at doses as high as 40 mg/kg (one to two times the human dose, based on mg/m 2 ) given daily over two years. No mutagenic activity was observed with mebendazole in a bacterial reverse gene mutation test. Mebendazole was mutagenic in the absence of S-9 when tested using a continuous (24 hour) treatment incubation period in the mouse lymphoma thymidine kinase assay.

Mebendazole was aneugenic in vitro in mammalian somatic cells. In the in vivo mouse micronucleus assay, orally administered mebendazole induced an increased frequency of micronucleated polychromatic erythrocytes with evidence suggestive of aneugenicity. Doses up to 40 mg/kg in rats (2 times the total daily human dose, based on mg/m 2 ), given to males for 60 days and to females for 14 days prior to gestation, had no effect upon fetuses and offspring.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 156 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In carcinogenicity tests of mebendazole in mice and rats, no carcinogenic effects were seen at doses as high as 40 mg/kg (one to two times the human dose, based on mg/m 2 ) given daily over two years. No mutagenic activity was observed with mebendazole in a bacterial reverse gene mutation test. Mebendazole was mutagenic in the absence of S-9 when tested using a continuous (24 hour) treatment incubation period in the mouse lymphoma thymidine kinase assay.

Mebendazole was aneugenic in vitro in mammalian somatic cells. In the in vivo mouse micronucleus assay, orally administered mebendazole induced an increased frequency of micronucleated polychromatic erythrocytes with evidence suggestive of aneugenicity. Doses up to 40 mg/kg in rats (2 times the total daily human dose, based on mg/m 2 ), given to males for 60 days and to females for 14 days prior to gestation, had no effect upon fetuses and offspring.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION EMVERM ® (EM-verm) (mebendazole) Chewable Tablets USP, for oral use What is EMVERM? Emverm is a prescription medicine used to treat adults and children 2 years of age and older with intestinal worm infections caused by pinworm, whipworm, roundworm, or hookworm. Who should not take EMVERM?

Do not take Emverm if you are allergic to mebendazole or any of the ingredients in Emverm. See the end of this leaflet for a complete list of ingredients in Emverm. Before you take EMVERM, tell your healthcare provider about all of your medical conditions, including if you: are pregnant or plan to become pregnant.

It is not known if EMVERM will harm your unborn baby. are breastfeeding or plan to breastfeed. EMVERM can pass into your milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take EMVERM.

Do not breastfeed while taking EMVERM. Tell your healthcare provider about all the medicines you take , including prescription and over-the­-counter medicines, vitamins, and herbal supplements. Using EMVERM with certain other medicines can change the way these medicines act, causing serious side effects.

Know the medicines you take. Keep a list of them to show to your healthcare provider or pharmacist when you get a new medicine. How should I take EMVERM?

Take EMVERM exactly as your healthcare provider tells you to take it. Take EMVERM by mouth with or without food. EMVERM tablets may be chewed, swallowed, or crushed and mixed with food.

If you take too much EMVERM, you might have symptoms that include stomach cramps, nausea, vomiting or diarrhea. What should I avoid while taking EMVERM? Do not take Emverm with metronidazole (a medicine used to treat bacterial and protozoan infections) as serious skin reactions called Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) can happen.

What are the possible side effects of EMVERM? EMVERM may cause serious side effects, including: Low white blood cell count (neutropenia). Neutropenia can cause you to get other infections.

Your healthcare provider will check your blood count regularly during your treatment with EMVERM. Tell your healthcare provider right away if you have a fever or any signs of an infection while taking EMVERM Severe skin reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis). EMVERM may cause rare, but serious skin reactions when taken with metronidazole and other medicines that contain mebendazole.

These severe allergic reactions may be life-threatening and need to be treated in a hospital. Call your healthcare provider right away or get emergency medical help if you have any allergic reactions or the following symptoms: severe skin blisters sores around the mouth, nose, eyes, vagina or penis (genitals) peeling skin swollen face, lips, mouth, tongue or throat itchy rash (hives) The most common side effects of EMVERM include: loss of appetite (anorexia) stomach pain diarrhea passing gas nausea vomiting rash Tell your healthcare provider if you have any side effect that bothers you or does not go away.

These are not all the possible side effects of EMVERM. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store EMVERM? Store at room temperature between 68°F to 77°F (20°C to 25°C). Safely throw away medicine that is out of date or no longer needed.

Keep EMVERM and all medicines out of the reach of children. General information about the safe and effective use of EMVERM. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.

Do not use EMVERM for a condition for which it was not prescribed. Do not give EMVERM to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about EMVERM that is written for health professionals. What are the ingredients in EMVERM? Active ingredient: me… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 4 words ▾

PRINCIPAL DISPLAY PANEL 1

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
13.1K
Units reimbursed last 4 qtrs
29.1K
Gross reimbursed last 4 qtrs
$20.55M
Avg / prescription
$1,574.26
Avg / unit
$706.23
Latest quarter Q4 2025
3.4KRx
Medicaid pays / ea
$706.23
gross reimbursed
vs
NADAC / ea
$712.47
acquisition cost
=
Spread
−$6.2370
-1% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
37% FFS 63% MCO
Fee-for-service · 4,856 Rx Managed care · 8,195 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 150 units · 1.9 per 100k residents WA Idaho: 164 units · 8.4 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 27 units · 0.5 per 100k residents MN Wisconsin: 437 units · 7.4 per 100k residents WI Michigan: 114 units · 1.1 per 100k residents MI New York: 4,822 units · 24.6 per 100k residents NY Vermont: no data reported VT New Hampshire: 26 units · 1.9 per 100k residents NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: 65 units · 7.1 per 100k residents SD Iowa: 21 units · 0.7 per 100k residents IA Illinois: 293 units · 2.3 per 100k residents IL Indiana: 404 units · 5.9 per 100k residents IN Ohio: no data reported OH Pennsylvania: 751 units · 5.8 per 100k residents PA New Jersey: 30 units · 0.3 per 100k residents NJ Massachusetts: no data reported MA California: 3,206 units · 8.2 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 2,088 units · 33.7 per 100k residents MO Kentucky: 2,154 units · 47.6 per 100k residents KY West Virginia: 28 units · 1.6 per 100k residents WV Virginia: 123 units · 1.4 per 100k residents VA Maryland: 180 units · 2.9 per 100k residents MD Connecticut: 245 units · 6.8 per 100k residents CT Rhode Island: no data reported RI Arizona: 570 units · 7.7 per 100k residents AZ New Mexico: no data reported NM Kansas: 337 units · 11.5 per 100k residents KS Arkansas: no data reported AR Tennessee: 340 units · 4.8 per 100k residents TN North Carolina: 2,695 units · 24.9 per 100k residents NC South Carolina: 623 units · 11.6 per 100k residents SC Delaware: no data reported DE Oklahoma: 157 units · 3.9 per 100k residents OK Louisiana: 1,302 units · 28.5 per 100k residents LA Mississippi: 494 units · 16.8 per 100k residents MS Alabama: 120 units · 2.3 per 100k residents AL Georgia: 391 units · 3.5 per 100k residents GA D.C.: no data reported DC Hawaii: 116 units · 8.1 per 100k residents HI Texas: 6,299 units · 20.7 per 100k residents TX Florida: 320 units · 1.4 per 100k residents FL
Units reimbursed · per 100k residents
0.347.6
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Kentucky 47.6 /100k
2 Missouri 33.7 /100k
3 Louisiana 28.5 /100k
4 North Carolina 24.9 /100k
5 New York 24.6 /100k
6 Texas 20.7 /100k
7 Mississippi 16.8 /100k
8 South Carolina 11.6 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for Emverm — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Emverm. 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
$2.25M
Claims incl. refills
514
Beneficiaries
446
Spend / beneficiary
$5,050.86
Spend / claim
$4,382.65
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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) ✓ Available
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) ✓ Available
“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

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Who lists this product with the FDA?
Amneal Pharmaceuticals LLC 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.
← 64896-0664-01 · Amneal 64896-0673-10 · Amneal →
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.