Dapsone by Zydus Lifesciences Limited / Zydus Pharmaceuticals Limited DAPSONE tablet

Dapsone by

Drug Labeling and Warnings

Dapsone by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited, Zydus Pharmaceuticals Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 70771-1979-3 in bottle of 30 tablets

Dapsone Tablets USP, 25 mg

Rx only

30 tablets

NDC: 70771-1980-3 in bottle of 30 tablets

Dapsone Tablets USP, 100 mg

Rx only

30 tablets

INGREDIENTS AND APPEARANCE

DAPSONE 
dapsone tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1979
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DAPSONE (UNII: 8W5C518302) (DAPSONE - UNII:8W5C518302)	DAPSONE	25 mg

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	WHITE (white to off white)	Score	2 pieces
Shape	ROUND	Size	6mm
Flavor		Imprint Code	1713
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1979-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/27/2026
2	NDC: 70771-1979-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/27/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA220103	02/27/2026

DAPSONE 
dapsone tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1980
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DAPSONE (UNII: 8W5C518302) (DAPSONE - UNII:8W5C518302)	DAPSONE	100 mg

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	WHITE (White to off white)	Score	2 pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code	1714
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1980-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/27/2026
2	NDC: 70771-1980-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/27/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA220103	02/27/2026

Labeler - Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Pharmaceuticals Limited		650173735	MANUFACTURE(70771-1979, 70771-1980) , ANALYSIS(70771-1979, 70771-1980)