Dapsone

Product NDC
82804-989
11-digit product format
828040989
Labeler code
82804
Product ID
82804-989_9cfe5fe7-abc7-4f48-a597-1b1a5c70a354
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dapsone
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA086842
Marketing category
ANDA
Marketing start
2024-01-16
Substance
DAPSONE
Active strength
100 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
82804-989-0082804098900100 TABLET in 1 BOTTLE (82804-989-00) 100 tablet2024-05-21NoNoHistorical
82804-989-11828040989111000 TABLET in 1 BOTTLE (82804-989-11) 1000 tablet2024-05-21NoNoHistorical
82804-989-308280409893030 TABLET in 1 BOTTLE (82804-989-30) 30 tablet2024-05-21NoNoHistorical
82804-989-5582804098955500 TABLET in 1 BOTTLE (82804-989-55) 500 tablet2024-05-21NoNoHistorical
82804-989-608280409896060 TABLET in 1 BOTTLE (82804-989-60) 60 tablet2024-05-21NoNoHistorical
82804-989-6482804098964240 TABLET in 1 BOTTLE (82804-989-64) 240 tablet2024-05-21NoNoHistorical
82804-989-7282804098972120 TABLET in 1 BOTTLE (82804-989-72) 120 tablet2024-05-21NoNoHistorical
82804-989-7882804098978180 TABLET in 1 BOTTLE (82804-989-78) 180 tablet2024-05-21NoNoHistorical
82804-989-908280409899090 TABLET in 1 BOTTLE (82804-989-90) 90 tablet2024-05-21NoNoHistorical

Related DailyMed Labels

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