Dapsone

Product NDC
69367-410
11-digit product format
693670410
Labeler code
69367
Product ID
69367-410_94a7ec84-91fc-4cb2-9ddc-49e82e94408f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dapsone
Dosage form
TABLET
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Application
ANDA086842
Marketing category
ANDA
Marketing start
2025-08-21
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
69367-410-01Dapsone100 in 1 BOTTLETABLET1002
69367-410-30Dapsone30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-410-01EA - Each69367-410898b92f9-6d7d-453d-acd3-b452808114d212025-10-14
69367-410-30EA - Each69367-410d884b16a-11ea-4015-94c2-ea51b928a59f12025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197557dapsone 100 MG Oral TabletPSN7d317576-5edd-4c27-a00d-68b5944c04a82
197558dapsone 25 MG Oral TabletPSN7d317576-5edd-4c27-a00d-68b5944c04a82
197557dapsone 100 MG Oral TabletSCD7d317576-5edd-4c27-a00d-68b5944c04a82
197558dapsone 25 MG Oral TabletSCD7d317576-5edd-4c27-a00d-68b5944c04a82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69367-410-0169367041001100 TABLET in 1 BOTTLE (69367-410-01) 100 tablet2025-08-21NoNoHistorical
69367-410-306936704103030 TABLET in 1 BOTTLE (69367-410-30) 30 tablet2025-08-21NoNoHistorical