FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
Dapsone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DAPSONE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8W5C518302
Rxcui197557, 197558

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ae3f83f-9ccb-db71-5718-0b1e959868dfProduct name520260113
5ae2790a-f798-4a69-8811-64a4723c389aProduct name520250325
b8929bfc-0002-d39a-046d-72ddf714efbeProduct name620190618

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82804-988-00Dapsone100 in 1 BOTTLETABLET1001
82804-988-11Dapsone1000 in 1 BOTTLETABLET10001
82804-988-30Dapsone30 in 1 BOTTLETABLET301
82804-988-55Dapsone500 in 1 BOTTLETABLET5001
82804-988-60Dapsone60 in 1 BOTTLETABLET601
82804-988-64Dapsone240 in 1 BOTTLETABLET2401
82804-988-72Dapsone120 in 1 BOTTLETABLET1201
82804-988-78Dapsone180 in 1 BOTTLETABLET1801
82804-988-90Dapsone90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-988-00EA - Each82804-98813ee98be-7dbe-4c3f-ae4a-9814c344f8da12024-07-12
82804-988-11EA - Each82804-98807022ec0-dc7d-4ae0-af3c-07b9d294dc7112024-07-12
82804-988-30EA - Each82804-988dd224fda-5c99-4a20-848d-a5e53b6a0e2b12024-07-12
82804-988-55EA - Each82804-98800010b72-0492-4c23-830a-20659717c0a612024-07-12
82804-988-60EA - Each82804-9882c538026-6d70-4631-8a31-40bc4b58a7ff12024-07-12
82804-988-64EA - Each82804-988dca31420-d5c1-40c4-a4bc-543cd07d8dc612024-07-12
82804-988-72EA - Each82804-988dfeb2028-98d6-4758-949b-4a2de636266c12024-07-12
82804-988-78EA - Each82804-98893bd9649-61ba-4e2a-a6ec-54adf35ffcf912024-07-12
82804-988-90EA - Each82804-988d7caaf93-e84a-4d9d-8ef1-a38b0077f0e712024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-988DAPSONE TABLET [PROFICIENT RX LP]1Current NDC, 9 package rows20240522_9cfe5fe7-abc7-4f48-a597-1b1a5c70a354.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197557dapsone 100 MG Oral TabletPSN9cfe5fe7-abc7-4f48-a597-1b1a5c70a3541
197558dapsone 25 MG Oral TabletPSN9cfe5fe7-abc7-4f48-a597-1b1a5c70a3541
197557dapsone 100 MG Oral TabletSCD9cfe5fe7-abc7-4f48-a597-1b1a5c70a3541
197558dapsone 25 MG Oral TabletSCD9cfe5fe7-abc7-4f48-a597-1b1a5c70a3541

Packages#

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