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Dapsone

DAPSONETablets, USP25 mg & 100 mg

Approved
Approval ID

229af266-d901-43e2-828a-4931d1124ea3

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 19, 2025

Manufacturers
FDA

Seton Pharmaceuticals

DUNS: 828898002

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Dapsone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code13925-505
Application NumberANDA086842
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dapsone
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 19, 2025
FDA Product Classification

INGREDIENTS (5)

DapsoneActive
Quantity: 100 mg in 1 1
Code: 8W5C518302
Classification: ACTIB
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT

Dapsone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code13925-504
Application NumberANDA086841
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dapsone
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 19, 2025
FDA Product Classification

INGREDIENTS (5)

CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
DAPSONEActive
Quantity: 25 mg in 1 1
Code: 8W5C518302
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 4/30/2020

Principal Display Panel - 100 mg 30 count

Contains 12: NDC 13925-505-30

Dapsone
Tablets USP
100 mg

12 cartons each containing

30 Tablets (2 x 15 unit of use)

Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].

Protect From Light

image description

Principal Display Panel - 100 mg 30 count

NDC 13925-505-01

DAPSONE
Tablets, USP

100 mg

100 tablets

Caution: Federal law prohibits dispensing
without prescription. Dispense this product
in a well closed, light-resistant container
with child resistant closure.

image description

DESCRIPTION SECTION

LOINC: 34089-3Updated: 4/30/2020

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 in-soluble in water and insoluble in fixed and vegetable oils.

Dapsone is issued on prescription in tablets of 25 and 100 mg for oral use.

Structural Formula

Inactive Ingredients: Colloidal silicone dioxide, magnesium stearate, microcrystalline cellulose and corn starch.

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 in-soluble in water and insoluble in fixed and vegetable oils.

Dapsone is issued on prescription in tablets of 25 and 100 mg for oral use.

Inactive Ingredients: Colloidal silicone dioxide, magnesium stearate, microcrystalline cellulose and corn starch.

<p class="First">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 in-soluble in water and insoluble in fixed and vegetable oils.</p><p>Dapsone is issued on prescription in tablets of 25 and 100 mg for oral use.</p><div class="Figure"><img id="mm01" src="/validator- lite/validator/spl/2d014f94-1f55-4f1c-8152-469a5bdb4f02/image-1-dapsone- structure.jpg" alt="" data-mce- src="../validator/spl/2d014f94-1f55-4f1c-8152-469a5bdb4f02/image-1-dapsone- structure.jpg"></div><p>Inactive Ingredients: Colloidal silicone dioxide, magnesium stearate, microcrystalline cellulose and corn starch.</p>

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Dapsone - FDA Drug Approval Details