Dapsone
DAPSONE TABLETS, USP
Approved
Approval ID
93028aff-54f0-4f94-b925-a91400118294
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 29, 2025
Manufacturers
FDA
Chartwell RX, LLC
DUNS: 079394054
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 Code62135-965
Application NumberANDA204074
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dapsone
Product Specifications
Route of AdministrationORAL
Effective DateApril 29, 2025
FDA Product Classification
INGREDIENTS (5)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
DAPSONEActive
Quantity: 25 mg in 1 1
Code: 8W5C518302
Classification: ACTIB
Dapsone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62135-966
Application NumberANDA204074
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dapsone
Product Specifications
Route of AdministrationORAL
Effective DateApril 29, 2025
FDA Product Classification
INGREDIENTS (5)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
DAPSONEActive
Quantity: 100 mg in 1 1
Code: 8W5C518302
Classification: ACTIB