Dapsone

Product NDC
72578-178
11-digit product format
725780178
Labeler code
72578
Product ID
72578-178_710844ec-6a59-45fa-b72a-4d75a4857361
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dapsone
Dosage form
TABLET
Route
ORAL
Labeler
Viona Pharmaceuticals Inc
Application
ANDA220103
Marketing category
ANDA
Marketing start
2026-02-27
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
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
72578-178-01Dapsone100 in 1 BOTTLETABLET1001
72578-178-06Dapsone30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72578-178-01EA - Each72578-178fc7a90e0-ecc1-48fe-9d94-8ea5bc203bcd12026-04-20
72578-178-06EA - Each72578-1783d6e7963-41b2-43af-a073-6f3fd01fe6fb12026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197557dapsone 100 MG Oral TabletPSN58e7b363-99fb-4225-8df1-db2114d749281
197558dapsone 25 MG Oral TabletPSN58e7b363-99fb-4225-8df1-db2114d749281
197557dapsone 100 MG Oral TabletSCD58e7b363-99fb-4225-8df1-db2114d749281
197558dapsone 25 MG Oral TabletSCD58e7b363-99fb-4225-8df1-db2114d749281

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72578-178-0172578017801100 TABLET in 1 BOTTLE (72578-178-01) 100 tablet2026-02-27NoNoHistorical
72578-178-067257801780630 TABLET in 1 BOTTLE (72578-178-06) 30 tablet2026-02-27NoNoHistorical