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DAPSONE 25 mg Tablet, 100-count — NDC 70954-0135-20 package photo

DAPSONE 25 mg Tablet, 100-count

by ANI Pharmaceuticals, Inc. · 100 TABLET in 1 BOTTLE (70954-135-20)
NDC 70954-0135-20
🏷️ FDA NDC (as labeled) 70954-135-20 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.4852 NADAC Per package$48.52 / 100 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.6903/unit · Part D plans $0.7885/unit — full pricing hub ↓
Also comes in: 30 tablets 70954-0135-10
Rx only Generic On market Non-controlled
🗂️ Data synced 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

⚠️
Other active recalls for Dapsone (different manufacturers) — 4 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Dec 10, 2024 — Crystallization (VIONA PHARMACEUTICALS INC) · FDA recall D-0172-2025
Class II · Dec 10, 2024 — Crystallization (VIONA PHARMACEUTICALS INC) · FDA recall D-0171-2025
Class II · Oct 29, 2024 — Crystallization (VIONA PHARMACEUTICALS INC) · FDA recall D-0038-2025
Class II · Sep 24, 2024 — Crystallization (VIONA PHARMACEUTICALS INC) · FDA recall D-0011-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 70954-135-20
Product NDC 70954-135
11-digit billing NDC 70954013520
NCPDP billing unit EA — each (per item)
RxCUI 197557, 197558
UNII 8W5C518302
UPC 0370954135104, 0370954136200, 0370954135203, 0370954136101
Application # ANDA206505
SPL Set ID 57a47368-d1f6-4d61-a2ee-c5f1fe7ff690
Established class (EPC) Sulfone
Chemical class Sulfones
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-01-15
Route ORAL
Dosage form TABLET
Substance DAPSONE
GPI-14 16300010000310
GPI class Dapsone
GCN Seq No 009623
GCN 43361
HICL code 004177
Ingredient (HICL) Dapsone
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W4
Therapeutic class — intermediate (HIC2) Antiparasitics
HIC3 code W4P
Therapeutic class — specific (HIC3) Antileprotics
AHFS code 08:16.08.00
AHFS class Antileprosy Agents
FDB label name DAPSONE 25 MG TABLET
FDB brand name Dapsone
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 70954-135-20 — 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 → 70954-0135-20. 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 Sulfone class.

Pharmacologic class Sulfone
Drug family (ATC) Other anti-acne preparations for topical use, Drugs for treatment of lepra
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.

🏭 Manufacturer & labeler

LabelerANI Pharmaceuticals, Inc.
Application holderNOVITIUM PHARMA LLC
FDA applicationANDA206505 (ANDA)
Labeler code70954
First marketedJan 2018
Product typeHuman Prescription Drug
Portfolio299 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.

🩺 Clinical

Label name DAPSONE 25 MG TABLET Ingredient Dapsone
📗 Our plain-language guide HelloPharmacist
  • 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?
📖 Read our full Dapsone guide →
7
Nutrient depletion considerations

Dapsone may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Dapsone nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.

💊 What it looks like

Color White
ShapeRound
ImprintN;136
Size8 mm
ScoringScored — splits in 2
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 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 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 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 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?
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.

💲 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 $0.485 $48.52 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.6903 $69.03 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.7885 $78.85 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.646 $0.485
▼ Down 16% over the last 24 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice 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 mgthis 70954-0135-20 ANI 100 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 +8%
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 mg 82804-0988-00 Proficient 100 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 —
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

🏛️
2018
On the market since
Jan 2018
📍
2026
Currently FDA-listed
8 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.

🗺️ 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 70954-0135-20, 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
1.5K
Units reimbursed last 4 qtrs
98.9K
Gross reimbursed last 4 qtrs
$68.3K
Avg / prescription
$46.09
Avg / unit
$0.6903
Latest quarter Q4 2025
293Rx
Medicaid pays / ea
$0.6903
gross reimbursed
vs
NADAC / ea
$0.4852
acquisition cost
=
Spread
+$0.2051
+42% 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 ⓘ
33% FFS 67% MCO
Fee-for-service · 496 Rx Managed care · 985 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 12,955 units · 166 per 100k residents WA Idaho: 870 units · 44.3 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 2,254 units · 39.3 per 100k residents MN Wisconsin: 6,531 units · 111 per 100k residents WI Michigan: 9,159 units · 91.3 per 100k residents MI New York: 5,050 units · 25.8 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 7,761 units · 61.8 per 100k residents IL Indiana: no data reported IN Ohio: 5,240 units · 44.5 per 100k residents OH Pennsylvania: 4,618 units · 35.6 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 11,048 units · 28.4 per 100k residents CA Utah: no data reported UT Colorado: 2,385 units · 40.6 per 100k residents CO Nebraska: 2,740 units · 139 per 100k residents NE Missouri: 2,642 units · 42.6 per 100k residents MO Kentucky: 1,687 units · 37.3 per 100k residents KY West Virginia: 1,110 units · 62.7 per 100k residents WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: 2,367 units · 112 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 2,282 units · 32.0 per 100k residents TN North Carolina: 6,935 units · 64.0 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 6,186 units · 135 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 648 units · 2.1 per 100k residents TX Florida: 702 units · 3.1 per 100k residents FL
Units reimbursed · per 100k residents
2.1166
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 Washington 166 /100k
2 Nebraska 139 /100k
3 Louisiana 135 /100k
4 New Mexico 112 /100k
5 Wisconsin 111 /100k
6 Michigan 91.3 /100k
7 North Carolina 64.0 /100k
8 West Virginia 62.7 /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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
30 tablets70954-0135-10 1,826 Rx · $84,762
100 tablets this page70954-0135-20 1,481 Rx · $68,259
Drug total (last 4 qtrs): 3,307 Rx · 221,018 units · $153,021 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Dapsone — the program that covers self-administered drugs. 14 manufacturers.
⚠️ 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 Dapsone. 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
$1.61M
Claims incl. refills
22.8K
Beneficiaries
14.4K
Spend / beneficiary
$111.86
Spend / claim
$70.63
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.

🔬 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 Dapsone — the ingredient across all brands.

Top reported reactions

Nausea487
Methaemoglobinaemia481
Fatigue477
Pyrexia468
Diarrhoea424
Rash398
Dyspnoea387

Age at onset

Neonate10
Infant17
Child28
Adolescent57
Adult1,101
Elderly446

Reporter sex

10,640 reports
Male · 45%
Female · 54%
Unknown · 0%

Serious outcomes

Hospitalization3,830
Death934
Life-threatening655
Disabling210
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 933 0
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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
70954-0135-10 30 TABLET in 1 BOTTLE (70954-135-10) $0.4852 / ea $14.56 2018-01-15 Active
70954-0135-20 You're viewing this 100 TABLET in 1 BOTTLE (70954-135-20) $0.4852 / ea $48.52 2018-01-15 Active

You're viewing the largest of 2 pack sizes for this product.

This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.4852 NADAC).

This pack accounts for about 45% of this product's recent Medicaid fills; most go to the 30 tablets pack. See all packs ↓

Pack size FAQ

What quantity is in NDC 70954-0135-20?
NDC 70954-0135-20 is a 100-count package — 100 tablet in 1 bottle.
What is the difference between NDC 70954-0135-20 and NDC 70954-0135-10?
Both are DAPSONE 25 mg Tablet — the drug itself is identical. NDC 70954-0135-20 is the 100-count package, while NDC 70954-0135-10 is the 30 tablets package.
What NDC number is used to bill for this package of DAPSONE 25 mg Tablet?
Bill NDC 70954-0135-20 — the 11-digit billing format is 70954013520. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
⛔ Contraindications 7 words ▾

CONTRAINDICATIONS Hypersensitivity to Dapsone and/or its derivatives.

⚠️ Warnings ~1 min read ▾

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 ~1 min read ▾

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. Falsely Reduced HbA1c Falsely reduced HbA1c measurements have been reported with dapsone use.

Alternate measures of glycemic control (e.g., fructosamine and/or more frequent blood glucose monitoring) are recommended when a discordance between HbA1c and blood glucose concentrations are observed or suspected. Falsely reduced HbA1c may occur without overt evidence of hemolysis or anemia. 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.

🆘 Overdosage 109 words ▾

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 188 words ▾

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.

📦 How Supplied / Storage and Handling 90 words ▾

HOW SUPPLIED Dapsone Tablets USP, 25 mg are available as white to creamy white, uncoated round shaped tablets, debossed with “N” above the bisect and “135” below the bisect and plain on other side. Bottle of 30 tablets NDC 70954-135-10 Bottle of 100 tablets NDC 70954-135-20 Dapsone Tablets USP, 100 mg are available as white to creamy white, uncoated round shaped tablets, debossed with “N” above the bisect and “136” below the bisect and plain on other side. Bottle of 30 tablets NDC 70954-136-10 Bottle of 100 tablets NDC 70954-136-20

📋 Description 77 words ▾

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 to yellow crystalline powder.

Sparingly soluble in alcohol; Soluble in acetone and in dilute mineral acids; practically insoluble in water. 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.

USP Dissolution Test Pending. STRUCTURE

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70954-0085-10 · Novitium 70954-0136-10 · ANI →
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.