ULTRAMICROSIZE GRISEOFULVIN 165 mg Tablet, 30-count
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Tubulin Inhibiting Agent class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- It really can be — and that's one of the most important things to understand about this medication. Fungal infections of the nails especially can take at least 4 to 6 months to cle...
- How long do I have to take griseofulvin? It seems like a really long time.
- Yes, and specifically with a fatty meal if you can. Studies show that eating something high in fat — like a full meal with dairy or meat — dramatically increases how much of the me...
- It's best to avoid alcohol entirely during treatment. The combination of griseofulvin and alcohol has been reported to cause an unpleasant and potentially dangerous reaction — naus...
Patient education
Supplement & herbal interactions
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🧪 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.
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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.
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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.
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UNII Q662QK8M3B
Polyethylene glycol 8000 is a synthetic polymer made from ethylene oxide. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the medicine.
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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.
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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.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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
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💲 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 system | Per each | Per 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 | $21.88 | $656.50 / 30 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ultramicrosize Griseofulvin 165 mgthis 62135-0501-30 | Chartwell | 30 tablets | — | AB | FDA listed | — |
| Ultramicrosize Griseofulvin 165 mg 73308-0435-30 | Ayurax, | 30 tablets | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 62135-0501-30 You're viewing this | 30 TABLET in 1 BOTTLE (62135-501-30) | 2025-01-30 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS Ultramicrosize griseofulvin tablets are indicated for the treatment of ringworm infections of the skin, hair, and nails, namely: tinea corporis, tinea pedis, tinea cruris, tinea barbae, tinea capitis, tinea unguium (onychomycosis) when caused by one or more of the following genera of fungi: Trichophyton rubrum, Trichophyton tonsurans, Trichophyton mentagrophytes, Trichophyton interdigitale, Trichophyton verrucosum, Trichophyton megninii, Trichophyton gallinae, Trichophyton crateriforme, Trichophyton sulphureum, Trichophyton schoenieinii, Microsporum audouini, Microsporum canis, Microsporum gypseum, and Epidermophyton floccosum.
Note: Prior to therapy, the type of fungi responsible for the infection should be identified. The use of this drug is not justified in minor or trivial infections which will respond to topical agents alone. Griseofulvin is not effective in the following: bacterial infections, candidiasis (moniliasis), histoplasmosis, actinomycosis, sporotrichosis, chromoblastomycosis, coccidioidomycosis, North American blastomycosis, cryptococcosis (torulosis), tinea versicolor, and nocardiosis.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Accurate diagnosis of the infecting organism is essential. Identification should be made either by direct microscopic examination of a mounting of infected tissue in a solution of potassium hydroxide or by culture on an appropriate medium. Medication must be continued until the infecting organism is completely eradicated as indicated by appropriate clinical or laboratory examination.
Representative treatment periods are tinea capitis, 4 to 6 weeks; tinea corporis, 2 to 4 weeks; tinea pedis, 4 to 8 weeks; tinea unguium – depending on rate of growth – fingernails, at least 4 months; toenails, at least 6 months. General measures in regard to hygiene should be observed to control sources of infection or reinfection. Concomitant use of appropriate topical agents is usually required, particularly in treatment of tinea pedis.
In some forms of athlete’s foot, yeasts and bacteria may be involved as well as fungi. Griseofulvin will not eradicate the bacterial or monilial infection. Adults: Daily administration of 330 mg (as a single dose or in divided amounts) will give a satisfactory response in most patients with tinea corporis, tinea cruris, and tinea capitis.
For those fungus infections more difficult to eradicate, such as tinea pedis and tinea unguium, a divided daily dosage of 660 mg is recommended. Children: Approximately 3.3 mg per pound of body weight per day is an effective dose for most children. On this basis, the following dosage schedule is suggested: Children weighing 30 to 50 pounds- 82.5 mg to 165 mg daily.
Children weighing over 50 pounds – 165 mg to 330 mg daily. Children 2 years of age and younger – dosage has not been established. Clinical experience with griseofulvin in children with tinea capitis indicates that a single daily dose is effective.
Clinical relapse will occur if the medication is not continued until the infecting organism is eradicated.
⛔ Contraindications ▾
CONTRAINDICATIONS This drug is contraindicated in patients with porphyria, hepatocellular failure, and in individuals with a history of hypersensitivity to griseofulvin. Rare cases of conjoined twins have been reported in patients taking griseofulvin during the first trimester of pregnancy. Griseofulvin should not be prescribed to pregnant patients or to women contemplating pregnancy.
⚠️ Warnings ▾
WARNINGS Prophylactic Usage: Safety and efficacy of griseofulvin for prophylaxis of fungal infections have not been established. Since griseofulvin has demonstrated harmful effects in vitro on the genotype in bacteria, plants, and fungi, males should wait at least 6 months after completing griseofulvin therapy before fathering a child. Females should avoid risk of pregnancy while receiving griseofulvin therapy.
Animal Toxicology : Chronic feeding of griseofulvin, at levels ranging from 0.5-2.5% of the diet, resulted in the development of liver tumors in several strains of mice, particularly in males. Smaller particle sizes result in an enhanced effect. Lower oral dosage levels have not been tested.
Subcutaneous administration of relatively small doses of griseofulvin once a week during the first 3 weeks of life has also been reported to induce hepatomata in mice. Thyroid tumors, mostly adenomas but some carcinomas, have been reported in male rats receiving griseofulvin at levels of 2.0%, 1.0%, and 0.2% of the diet, and in female rats receiving the two higher dose levels. Although studies in other animal species have not yielded evidence of tumorigenicity, these studies were not of adequate design to form a basis for conclusions in this regard.
In subacute toxicity studies, orally administered griseofulvin produced hepatocellular necrosis in mice, but this has not been seen in other species. Disturbances in porphyrin metabolism have been reported in griseofulvin-treated laboratory animals. Griseofulvin has been reported to have a colchicine-like effect on mitosis and cocarcinogenicity with methylcholanthrene in cutaneous tumor induction in laboratory animals.
Griseofulvin interferes with chromosomal distribution during cell division, causing aneuploidy in plant and mammalian cells. These effects have been demonstrated in vitro at concentrations that may be achieved in the serum with the recommended therapeutic dosage. Usage in Pregnancy: Griseofulvin should not be prescribed to pregnant patients or to women contemplating pregnancy (see CONTRAINDICATIONS ).
Animal Reproduction Studies: It has been reported in the literature that griseofulvin was found to be embryotoxic and teratogenic on oral administration to pregnant rats. Pups with abnormalities have been reported in the litters of a few bitches treated with griseofulvin. Suppression of spermatogenesis has been reported to occur in rats, but investigation in man failed to confirm this.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS When adverse reactions occur, they are most commonly of the hypersensitivity type, such as skin rashes and urticaria, and rarely, angioneurotic edema and epidermal necrolysis (Lyell’s syndrome), and may necessitate withdrawal of therapy and appropriate countermeasures. Paresthesias of the hands and feet have been reported rarely after extended therapy. Other side effects reported occasionally are oral thrush, nausea, vomiting, epigastric distress, diarrhea, headache, fatigue, dizziness, insomnia, mental confusion, and impairment of performance of routine activities.
Proteinuria, nephrosis, leukopenia, hepatic toxicity, GI bleeding, and menstrual irregularities have been reported rarely. Administration of the drug should be discontinued if granulocytopenia occurs. When rare, serious reactions occur with griseofulvin, they are usually associated with high dosages, long periods of therapy, or both.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Ultramicrosize Griseofulvin Tablets, USP 165 mg, off-white, oval shaped, scored tablets debossed with “ C ” bisect “ E ” on one side and “ 269 ” on the other side; bottle of 30 (NDC 62135-501-30). Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature]. Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L72564 Rev. 02/2025
📋 Description ▾
DESCRIPTION Ultramicrosize Griseofulvin Tablets, USP contain ultramicrosize crystals of griseofulvin, an antibiotic derived from a species of Penicillium . Griseofulvin crystals are partly dissolved in polyethylene glycol 8000 and partly dispersed throughout the label matrix. Each Ultramicrosize Griseofulvin Tablet, USP contains 165 mg ultramicrosize griseofulvin, USP.
The inactive ingredients for Ultramicrosize Griseofulvin Tablets, USP include: corn starch, lactose anhydrous, magnesium stearate, polyethylene glycol 8000, and sodium lauryl sulfate. ACTIONS Microbiology Griseofulvin is fungistatic with in vitro activity against various species of Microsporum, Epidermophyton , and Trichophyton . It has no effect on bacteria or on other genera of fungi.
Human Pharmacology Following oral administration, griseofulvin is deposited in the keratin precursor cells and has a greater affinity for diseased tissue. The drug is tightly bound to the new keratin which becomes highly resistant to fungal invasions. The efficiency of gastrointestinal absorption of ultramicrocrystalline griseofulvin is approximately one and one-half times that of the conventional microsize griseofulvin.
This factor permits the oral intake of two-thirds as much ultramicrocrystalline griseofulvin as the microsize form. However, there is currently no evidence that this lower dose confers any significant clinical differences with regard to safety and/or efficacy.