Dapsone
Ani Pharmaceuticals, Inc.
Human Prescription Drug
NDC 70954-135Dapsone is a human prescription drug labeled by 'Ani Pharmaceuticals, Inc.'. National Drug Code (NDC) number for Dapsone is 70954-135. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Dapsone drug includes Dapsone - 25 mg/1 . The currest status of Dapsone drug is Active.
Drug Information:
| Drug NDC: | 70954-135 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Dapsone |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Dapsone |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Ani Pharmaceuticals, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | DAPSONE - 25 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 15 Jan, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA206505 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | ANI Pharmaceuticals, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 197557
197558
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0370954135203
0370954136101
0370954135104
0370954136200
|
| UPC stands for Universal Product Code. |
| NUI: | N0000175881
M0020791
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 8W5C518302
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class EPC: | Sulfone [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class CS: | Sulfones [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Sulfone [EPC]
Sulfones [CS]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 70954-135-10 | 30 TABLET in 1 BOTTLE (70954-135-10) | 15 Jan, 2018 | N/A | No |
| 70954-135-20 | 100 TABLET in 1 BOTTLE (70954-135-20) | 15 Jan, 2018 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Dapsone dapsone dapsone dapsone silicon dioxide starch, corn magnesium stearate cellulose, microcrystalline white to creamy white n;135 dapsone dapsone dapsone dapsone silicon dioxide starch, corn magnesium stearate cellulose, microcrystalline white to creamy white n;136
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 shoul
Read more...d 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.
Contraindications:
Contraindications hypersensitivity to dapsone and/or its derivatives.
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
Read more...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.
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.
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 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
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 ad
Read more...ministration (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:
How supplied dapsone tablets usp, 25 mg are available as white to creamy white, uncoated round shaped tablets, debossed with ânâ above the bisect and â135â 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 ânâ above the bisect and â136â below the bisect and plain on other side. bottle of 30 tablets ndc 70954-136-10 bottle of 100 tablets ndc 70954-136-20
Package Label Principal Display Panel:
Package label.principal display panel principal display panel-25 mg container label ndc 70954- 135 -10 dapsone tablets usp, 25 mg rx only 30 tablets ndc 70954- 135 -20 dapsone tablets usp, 25 mg rx only 100 tablets dap-25mg-30counts dap-25mg-100counts principal display panel-100 mg container label ndc 70954- 136 -10 dapsone tablets usp, 100 mg rx only 30 tablets ndc 70954- 136 -20 dapsone tablets usp, 100 mg rx only 100 tablets dap-100mg-30counts dap-100mg-100counts