FDA.reportPublic FDA data

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DAPSONE100 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
82804-989-00Dapsone100 in 1 BOTTLETABLET1001
82804-989-11Dapsone1000 in 1 BOTTLETABLET10001
82804-989-30Dapsone30 in 1 BOTTLETABLET301
82804-989-55Dapsone500 in 1 BOTTLETABLET5001
82804-989-60Dapsone60 in 1 BOTTLETABLET601
82804-989-64Dapsone240 in 1 BOTTLETABLET2401
82804-989-72Dapsone120 in 1 BOTTLETABLET1201
82804-989-78Dapsone180 in 1 BOTTLETABLET1801
82804-989-90Dapsone90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-989-00EA - Each82804-989b2b1343c-5263-49a9-945e-ddf99d3add8712024-07-12
82804-989-11EA - Each82804-9892b3b7284-2814-4a8f-a1e5-672b284a96e912024-07-12
82804-989-30EA - Each82804-9893bba5271-da6d-4bee-aedf-93f6f02b291012024-07-12
82804-989-55EA - Each82804-989ef9b4a4a-3c9e-4353-96b9-d5697ea8330e12024-07-12
82804-989-60EA - Each82804-98972957ff8-137b-41c6-890f-0a1cac755a0412024-07-12
82804-989-64EA - Each82804-989ccf1f87d-c843-4dd5-8762-abce594a49a212024-07-12
82804-989-72EA - Each82804-989102993d1-08dd-40d6-927c-dfcef43ea0bb12024-07-12
82804-989-78EA - Each82804-989d255a84a-55d3-4844-aa05-1192705ebd5812024-07-12
82804-989-90EA - Each82804-989feffd7d3-b205-4c81-aa98-6195ddc216d912024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-989DAPSONE 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
82804-989-0082804098900100 TABLET in 1 BOTTLE (82804-989-00) 100 tablet2024-05-21NoNoCurrent
82804-989-11828040989111000 TABLET in 1 BOTTLE (82804-989-11) 1000 tablet2024-05-21NoNoCurrent
82804-989-308280409893030 TABLET in 1 BOTTLE (82804-989-30) 30 tablet2024-05-21NoNoCurrent
82804-989-5582804098955500 TABLET in 1 BOTTLE (82804-989-55) 500 tablet2024-05-21NoNoCurrent
82804-989-608280409896060 TABLET in 1 BOTTLE (82804-989-60) 60 tablet2024-05-21NoNoCurrent
82804-989-6482804098964240 TABLET in 1 BOTTLE (82804-989-64) 240 tablet2024-05-21NoNoCurrent
82804-989-7282804098972120 TABLET in 1 BOTTLE (82804-989-72) 120 tablet2024-05-21NoNoCurrent
82804-989-7882804098978180 TABLET in 1 BOTTLE (82804-989-78) 180 tablet2024-05-21NoNoCurrent
82804-989-908280409899090 TABLET in 1 BOTTLE (82804-989-90) 90 tablet2024-05-21NoNoCurrent