Dapsone 25 mg Tablet, 180-count
Other active recalls for Dapsone (different manufacturers) — 4 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Sulfone class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Dapsone is used to treat leprosy and skin infections. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Read the full MedlinePlus article ↗- It depends on the form. The dapsone tablet is used to treat leprosy and a blistering, itchy skin condition called dermatitis herpetiformis. The topical gel — including Aczone Gel —...
- Gently wash your face and pat it dry first. Then squeeze out about a pea-sized amount of Aczone Gel, 7.5% and apply a thin layer across your whole face once a day. You can also app...
- With the gel, the most common ones are mild — some dryness, oiliness, peeling, or redness where you apply it. One thing to know: if you also use a benzoyl peroxide product, applyin...
- What side effects should I watch out for?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Dapsone — tap one for details:
Dapsone may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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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 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 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.
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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.
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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.
4 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
Are inactive ingredients the same for every manufacturer?
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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 | $0.7885 | $141.93 / 180 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Dapsone 25 mg 64980-0567-01 | Rising | 100 tablets | $0.485 | AB | Availability likely | — |
| Dapsone 25 mg 69367-0378-01 | Westminster | 100 tablets | $0.485 | AB | Availability likely | — |
| Dapsone 25 mg 69367-0409-01 | Westminster | 100 tablets | $0.485 | AB | Availability likely | — |
| Dapsone 25 mg 70954-0135-10 | ANI | 30 tablets | $0.485 | AB | Availability likely | — |
| Dapsone 25 mg 72578-0177-01 | Viona | 100 tablets | $0.485 | AB | Availability likely | — |
| Dapsone 25 mg 13925-0504-01 | Seton | 100 tablets | $0.526 | AB | Discontinued | — |
| Dapsone 25 mg 42291-0008-01 | AvKARE | 100 tablets | — | AB | FDA listed | — |
| Dapsone 25 mg 51672-4197-02 | Sun | 30 tablets | — | — | Discontinued | — |
| Dapsone 25 mg 60429-0495-30 | Golden | 30 tablets | — | AB | FDA listed | — |
| Dapsone 25 mg 62135-0965-30 | Chartwell | 30 tablets | — | — | FDA listed | — |
| Dapsone 25 mg 70771-1979-01 | Zydus | 100 tablets | — | AB | FDA listed | — |
| Dapsone 25 mg 73190-0037-01 | AvKARE | 100 tablets | — | AB | FDA listed | — |
| Dapsone 25 mgthis 82804-0988-78 | Proficient | 180 tablets | — | AB | FDA listed | — |
| Dapsone 25 mg 83098-0102-01 | Everest | 100 tablets | — | AB | FDA listed | — |
| Dapsone 25mg 25 mg 85185-0104-01 | Solis | 30 tablets | — | AB | FDA listed | — |
| Dapsone 25 mg 33342-0534-07 | Macleods | 30 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
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?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 82804-0988-00 | 100 TABLET in 1 BOTTLE (82804-988-00) | 2024-05-21 | Active |
| 82804-0988-11 | 1000 TABLET in 1 BOTTLE (82804-988-11) | 2024-05-21 | Active |
| 82804-0988-30 | 30 TABLET in 1 BOTTLE (82804-988-30) | 2024-05-21 | Active |
| 82804-0988-55 | 500 TABLET in 1 BOTTLE (82804-988-55) | 2024-05-21 | Active |
| 82804-0988-60 | 60 TABLET in 1 BOTTLE (82804-988-60) | 2024-05-21 | Active |
| 82804-0988-64 | 240 TABLET in 1 BOTTLE (82804-988-64) | 2024-05-21 | Active |
| 82804-0988-72 | 120 TABLET in 1 BOTTLE (82804-988-72) | 2024-05-21 | Active |
| 82804-0988-78 You're viewing this | 180 TABLET in 1 BOTTLE (82804-988-78) | 2024-05-21 | Active |
| 82804-0988-90 | 90 TABLET in 1 BOTTLE (82804-988-90) | 2024-05-21 | Active |
You're viewing one of 9 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 82804-0988-78?
What is the difference between NDC 82804-0988-78 and NDC 82804-0988-30?
What NDC number is used to bill for this package of Dapsone 25 mg Tablet?
🧭 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 | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Dermatitis herpetiformis: (D.H.) Leprosy: All forms of leprosy except for cases of proven Dapsone resistance.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Dermatitis herpetiformis The dosage should be individually titrated starting in adults with 50 mg daily and correspondingly smaller doses in children. If full control is not achieved within the range of 50 to 300 mg daily, higher doses may be tried. Dosage should be reduced to a minimum maintenance level as soon as possible.
In responsive patients there is a prompt reduction in pruritus followed by clearance of skin lesions. There is no effect on the gastrointestinal component of the disease. Dapsone levels are influenced by acetylation rates.
Patients with high acetylation rates, or who are receiving treatment affecting acetylation may require an adjustment in dosage. A strict gluten free diet is an option for the patient to elect, permitting many to reduce or eliminate the need for Dapsone; the average time for dosage reduction is 8 months with a range of 4 months to 2 1/2 years and for dosage elimination 29 months with a range of 6 months to 9 years. Leprosy In order to reduce secondary Dapsone resistance, the WHO Expert Committee on Leprosy and the USPHS at Carville, LA, recommended that Dapsone should be commenced in combination with one or more anti-leprosy drugs.
In the multidrug program Dapsone should be maintained at the full dosage of 100 mg daily without interruption (with corresponding smaller doses for children) and provided to all patients who have sensitive organisms with new or recrudescent disease or who have not yet completed a two year course of Dapsone monotherapy. For advice and other drugs, the USPHS at Carville, LA (1-800-642-2477) should be contacted. Before using other drugs consult appropriate product labeling.
In bacteriologically negative tuberculoid and indeterminate disease, the recommendation is the coadministration of Dapsone 100 mg daily with six months of Rifampin 600 mg daily. Under WHO, daily Rifampin may be replaced by 600 mg Rifampin monthly, if supervised. The Dapsone is continued until all signs of clinical activity are controlled - usually after an additional six months.
Then Dapsone should be continued for an additional three years for tuberculoid and indeterminate patients and for five years for borderline tuberculoid patients. In lepromatous and borderline lepromatous patients, the recommendation is the coadministration of Dapsone 100 mg daily with two years of Rifampin 600 mg daily. Under WHO daily Rifampin may be replaced by 600 mg Rifampin monthly, if supervised.
One may elect the concurrent administration of a third anti-leprosy drug, usually either Clofazamine 50 to 100 mg daily or Ethionamide 250 to 500 mg daily. Dapsone 100 mg daily is continued 3 to 10 years until all signs of clinical activity are controlled with skin scrapings and biopsies negative for one year. Dapsone should then be continued for an additional 10 years for borderline patients and for life for lepromatous patients.
Secondary Dapsone resistance should be suspected whenever a lepromatous or borderline lepromatous patient receiving Dapsone treatment relapses clinically and bacteriologically, solid staining bacilli being found in the smears taken from the new active lesions. If such cases show no response to regular and supervised Dapsone therapy within three to six months or good compliance for the past 3 to 6 months can be assured, Dapsone resistance should be considered confirmed clinically. Determination of drug sensitivity using the mouse footpad method is recommended and, after prior arrangement, is available without charge from the USPHS, Carville, LA.
Patients with proven Dapsone resistance should be treated with other drugs. LEPROSY REACTIONAL STATES Abrupt changes in clinical activity occur in leprosy with any effective treatment and are known as reactional states. The majority can be classified into two groups.
The "Reversal" reaction (Type 1) may occur in borderline or tuberculoid leprosy patients often soon after chemotherapy is started. The mechanism is presumed to resul…
⛔ Contraindications ▾
CONTRAINDICATIONS Hypersensitivity to Dapsone and/or its derivatives.
⚠️ Warnings ▾
WARNINGS The patient should be warned to respond to the presence of clinical signs such as sore throat, fever, pallor, purpura or jaundice. Deaths associated with the administration of Dapsone have been reported from agranulocytosis, aplastic anemia and other blood dyscrasias. Complete blood counts should be done frequently in patients receiving Dapsone.
The FDA Dermatology Advisory Committee recommended that, when feasible, counts should be done weekly for the first month, monthly for six months and semi-annually thereafter. If a significant reduction in leucocytes, platelets or hemopoiesis is noted, Dapsone should be discontinued and the patient followed intensively. Folic acid antagonists have similar effects and may increase the incidence of hematologic reactions; if coadministered with Dapsone the patient should be monitored more frequently.
Patients on weekly pyrimethamine and Dapsone have developed agranulocytosis during the second and third month of therapy. Severe anemia should be treated prior to initiation of therapy and hemoglobin monitored. Hemolysis and methemoglobin may be poorly tolerated by patients with severe cardiopulmonary disease.
Cutaneous reactions, especially bullous, include exfoliative dermatitis and are probably one of the most serious, though rare, complications of sulfone therapy. They are directly due to drug sensitization. Such reactions include toxic erythema, erythema multiforme, toxic epidermal necrolysis, morbilliform and scarlatiniform reactions, urticaria and erythema nodosum.
If new or toxic dermatologic reactions occur, sulfone therapy must be promptly discontinued and appropriate therapy instituted. Leprosy reactional states, including cutaneous, are not hypersensitivity reactions to Dapsone and do not require discontinuation. See special section.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS In addition to the warnings listed above, the following syndromes and serious reactions have been reported in patients on Dapsone. Hematologic Effects Dose-related hemolysis is the most common adverse effect and is seen in patients with or without G6PD deficiency. Almost all patients demonstrate the inter-related changes of a loss of 1 to 2g of hemoglobin, an increase in the reticulocytes (2 to 12%), a shortened red cell life span and a rise in methemoglobin.
G6PD deficient patients have greater responses. Nervous System Effects Peripheral neuropathy is a definite but unusual complication of Dapsone therapy in non-leprosy patients. Motor loss is predominant.
If muscle weakness appears, Dapsone should be withdrawn. Recovery on withdrawal is usually substantially complete. The mechanism of recovery is reported by axonal regeneration.
Some recovered patients have tolerated retreatment at reduced dosage. In leprosy this complication may be difficult to distinguish from a leprosy reactional state. Body As A Whole In addition to the warnings and adverse effects reported above, additional adverse reactions include: nausea, vomiting, abdominal pains, pancreatitis, vertigo, blurred vision, tinnitus, insomnia, fever, headache, psychosis, phototoxicity, pulmonary eosinophilia, tachycardia, albuminuria, the nephrotic syndrome, hypoalbuminemia without proteinuria, renal papillary necrosis, male infertility, drug-induced Lupus erythematosus and an infectious mononucleosis-like syndrome.
In general, with the exception of the complications of severe anoxia from overdosage (retinal and optic nerve damage, etc.) these adverse reactions have regressed off drug.
🔄 Drug Interactions ▾
Drug Interactions Rifampin lowers Dapsone levels 7 to 10-fold by accelerating plasma clearance; in leprosy this reduction has not required a change in dosage. Folic acid antagonists such as pyrimethamine may increase the likelihood of hematologic reactions. A modest interaction has been reported for patients receiving 100 mg Dapsone daily in combination with trimethoprim 5 mg/kg q6h.
On Day 7, the serum Dapsone levels averaged 2.1 ± 1.0 mcg/mL in comparison to 1.5 ± 0.5 mcg/mL for Dapsone alone. On Day 7, trimethoprim levels averaged 18.4 ± 5.2 mcg/mL in comparison to 12.4 ± 4.5 mcg/mL for patients not receiving Dapsone. Thus, there is a mutual interaction between Dapsone and trimethoprim in which each raises the level of the other about 1.5 times.
A crossover study 1 designed to assess the potential of a drug interaction between Dapsone, 100 mg/day and trimethoprim, 200 mg every 12 hours, in eight asymptomatic HIV positive volunteers (average CD4 count 524 cells/mm 3 ) demonstrated that there was not a significant drug intreraction between Dapsone and trimethoprim. However, an earlier report 2 also by Lee et al, in 78 HIV infected patients with acute Pneumocystis carinii pneumonia, receiving Dapsone, 100 mg/day and higher trimethoprim dose, 20 mg/kg/day, demonstrated that the serum levels of Dapsone were increased by 40% and trimethoprim levels were increased by 48% when the drugs were administered concurrently.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects Pregnancy Category C Animal reproduction studies have not been conducted with Dapsone. Extensive, but uncontrolled experience and two published surveys on the use of Dapsone in pregnant women have not shown that Dapsone increases the risk of fetal abnormalities if administered during all trimesters of pregnancy or can affect reproduction capacity. Because of the lack of animal studies or controlled human experience, Dapsone should be given to a pregnant woman only if clearly needed.
In general, for leprosy, USPHS at Carville recommends maintenance of Dapsone. Dapsone has been important for the management of some pregnant D.H. patients.
🧒 Pediatric Use ▾
Pediatric Use Pediatric patients are treated on the same schedule as adults but with correspondingly smaller doses. Dapsone is generally not considered to have an effect on the later growth, development and functional development of the pediatric patient.
🆘 Overdosage ▾
OVERDOSAGE Nausea, vomiting, hyperexcitability can appear a few minutes up to 24 hours after ingestion of an overdosage. Methemoglobin induced depression, convulsions or severe cyanosis requires prompt treatment. In normal and methemoglobin reductase deficient patients, methylene blue, 1 to 2 mg/kg of body weight, given slowly intravenously, is the treatment of choice.
The effect is complete in 30 minutes, but may have to be repeated if methemoglobin reaccumulates. For non-emergencies, if treatment is needed, methylene blue may be given orally in doses of 3 to 5 mg/kg every 4 to 6 hours. Methylene blue reduction depends on G6PD and should not be given to fully expressed G6PD deficient patients.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Actions The mechanism of action in Dermatitis herpetiformis has not been established. By the kinetic method in mice, Dapsone is bactericidal as well as bacteriostatic against Mycobacterium leprae. Absorption and Excretion Dapsone, when given orally, is rapidly and almost completely absorbed.
About 85 percent of the daily intake is recoverable from the urine mainly in the form of water-soluble metabolites. Excretion of the drug is slow and a constant blood level can be maintained with the usual dosage. Blood Levels Detected a few minutes after ingestion, the drug reaches peak concentration in 4 to 8 hours.
Daily administration for at least eight days is necessary to achieve a plateau level. With doses of 200 mg daily, this level averaged 2.3 mcg/ml with a range of 0.1 to 7.0 mcg/ml. The half-life in the plasma in different individuals varies from ten hours to fifty hours and averages twenty-eight hours.
Repeat tests in the same individual are constant. Daily administration (50 to 100 mg) in leprosy patients will provide blood levels in excess of the usual minimum inhibitory concentration even for patients with a short Dapsone half-life.
🧬 Mechanism of Action ▾
Actions The mechanism of action in Dermatitis herpetiformis has not been established. By the kinetic method in mice, Dapsone is bactericidal as well as bacteriostatic against Mycobacterium leprae.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Dapsone Tablets USP, 25 mg are available as round white scored tablets, debossed "25" above and "102" below the score and on the obverse "JACOBUS" in light and child-resistant bottles. Bottle of 30 tablets: 82804-988-30 Bottle of 60 tablets: 82804-988-60 Bottle of 90 tablets: 82804-988-90 Bottle of 100 tablets: 82804-988-00 Bottle of 120 tablets: 82804-988-72 Bottle of 180 tablets: 82804-988-78 Bottle of 240 tablets: 82804-988-64 Bottle of 500 tablets: 82804-988-55 Bottle of 1000 tablets: 82804-988-11 Dapsone Tablets USP, 100 mg are available as round white scored tablets, debossed "100" above and "101" below the score and on the obverse "JACOBUS" in light and child-resistant bottles.
Bottle of 30 tablets: 82804-989-30 Bottle of 60 tablets: 82804-989-60 Bottle of 90 tablets: 82804-989-90 Bottle of 100 tablets: 82804-989-00 Bottle of 120 tablets: 82804-989-72 Bottle of 180 tablets: 82804-989-78 Bottle of 240 tablets: 82804-989-64 Bottle of 500 tablets: 82804-989-55 Bottle of 1000 tablets: 82804-989-11
📦 Storage and Handling ▾
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. Rx only. Keep this and all drugs out of the reach of children.
📋 Description ▾
DESCRIPTION Dapsone-USP, 4,4'-diaminodiphenylsulfone (DDS), is a primary treatment for Dermatitis herpetiformis. It is an antibacterial drug for susceptible cases of leprosy. It is a white, odorless crystalline powder, practically insoluble in water and in-soluble in fixed and vegetable oils.
Dapsone is issued on prescription in tablets of 25 and 100 mg for oral use. Inactive Ingredients: Colloidal Silicon Dioxide, Corn Starch, Magnesium Stearate and Microcrystalline Cellulose. Chemical Structure