Dapsone

Product NDC
72578-177
11-digit product format
725780177
Labeler code
72578
Product ID
72578-177_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
25 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
DAPSONE25 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
72578-177-01Dapsone100 in 1 BOTTLETABLET1001
72578-177-06Dapsone30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72578-177-01EA - Each72578-177f1ad7cfd-da0c-4df7-bb60-f1b924c6588c12026-04-20
72578-177-06EA - Each72578-1773787036f-632e-41fb-b2ae-87128aa0b96212026-04-20

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
72578-177-0172578017701100 TABLET in 1 BOTTLE (72578-177-01) 100 tablet2026-02-27NoNoCurrent
72578-177-067257801770630 TABLET in 1 BOTTLE (72578-177-06) 30 tablet2026-02-27NoNoCurrent