Dapsone

Product NDC
82804-988
11-digit product format
828040988
Labeler code
82804
Product ID
82804-988_9cfe5fe7-abc7-4f48-a597-1b1a5c70a354
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dapsone
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA086841
Marketing category
ANDA
Marketing start
2024-01-16
Substance
DAPSONE
Active strength
25 mg/1
Pharmacologic classes
Sulfone [EPC], Sulfones [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
8W5C518302DAPSONE80-08-0DAPSONE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-988-0082804098800100 TABLET in 1 BOTTLE (82804-988-00) 100 tablet2024-05-21NoNoHistorical
82804-988-11828040988111000 TABLET in 1 BOTTLE (82804-988-11) 1000 tablet2024-05-21NoNoHistorical
82804-988-308280409883030 TABLET in 1 BOTTLE (82804-988-30) 30 tablet2024-05-21NoNoHistorical
82804-988-5582804098855500 TABLET in 1 BOTTLE (82804-988-55) 500 tablet2024-05-21NoNoHistorical
82804-988-608280409886060 TABLET in 1 BOTTLE (82804-988-60) 60 tablet2024-05-21NoNoHistorical
82804-988-6482804098864240 TABLET in 1 BOTTLE (82804-988-64) 240 tablet2024-05-21NoNoHistorical
82804-988-7282804098872120 TABLET in 1 BOTTLE (82804-988-72) 120 tablet2024-05-21NoNoHistorical
82804-988-7882804098878180 TABLET in 1 BOTTLE (82804-988-78) 180 tablet2024-05-21NoNoHistorical
82804-988-908280409889090 TABLET in 1 BOTTLE (82804-988-90) 90 tablet2024-05-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Dapsone Tablets, USP 25 mg and 100 mgProficient Rx LP2024-05-01HUMAN PRESCRIPTION DRUG LABEL1