Dapsone 100 mg

Product NDC
83098-101
11-digit product format
830980101
Labeler code
83098
Product ID
83098-101_2127568d-553c-c142-e063-6394a90a4ef7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dapsone Tablets
Dosage form
TABLET
Route
ORAL
Labeler
Everest Life Sciences. LLC
Application
ANDA086842
Marketing category
ANDA
Marketing start
2024-09-01
Substance
DAPSONE
Active strength
100 mg/1
Pharmacologic classes
Sulfone [EPC], Sulfones [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dapsone 100 mg
Listing expiration
2027-12-31

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
83098-101-01Dapsone 100 mg100 in 1 BOTTLETABLET1002
83098-101-03Dapsone 100 mg30 in 1 BOTTLETABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83098-101DAPSONE 25 MG (DAPSONE TABLETS) TABLET DAPSONE 100 MG (DAPSONE TABLETS) TABLET [EVEREST LIFE SCIENCES. LLC]1Current NDC, 2 package rows20240902_1d026bb6-05da-e9cf-e063-6394a90a2485.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197557dapsone 100 MG Oral TabletPSN1d026bb6-05da-e9cf-e063-6394a90a24852
197558dapsone 25 MG Oral TabletPSN1d026bb6-05da-e9cf-e063-6394a90a24852
197557dapsone 100 MG Oral TabletSCD1d026bb6-05da-e9cf-e063-6394a90a24852
197558dapsone 25 MG Oral TabletSCD1d026bb6-05da-e9cf-e063-6394a90a24852

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83098-101-0183098010101100 TABLET in 1 BOTTLE (83098-101-01) 100 tablet2024-09-01NoNoCurrent
83098-101-038309801010330 TABLET in 1 BOTTLE (83098-101-03) 30 tablet2024-09-01NoNoCurrent