Dapsone

Product NDC
67046-1477
11-digit product format
670461477
Labeler code
67046
Product ID
67046-1477_2d018cbb-21a4-5f63-e063-6394a90aadc3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dapsone
Dosage form
TABLET
Route
ORAL
Labeler
Coupler LLC
Application
ANDA207165
Marketing category
ANDA
Marketing start
2025-01-31
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

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
67046-1477-3Dapsone30 in 1 BLISTER PACKTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-1477DAPSONE TABLET [COUPLER LLC]1Current NDC, 1 package rows20250201_2d018cbb-21b2-5f63-e063-6394a90aadc3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197557dapsone 100 MG Oral TabletPSN2d018cbb-21b2-5f63-e063-6394a90aadc31
197557dapsone 100 MG Oral TabletSCD2d018cbb-21b2-5f63-e063-6394a90aadc31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67046-1477-36704614770330 TABLET in 1 BLISTER PACK (67046-1477-3) 30 tablet2025-01-31NoNoCurrent