Dapsone

Product NDC
72578-094
11-digit product format
725780094
Labeler code
72578
Product ID
72578-094_fbed711e-945e-46aa-8883-fee0b7604485
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dapsone
Dosage form
GEL
Route
TOPICAL
Labeler
Viona Pharmaceuticals Inc
Application
ANDA214019
Marketing category
ANDA
Marketing start
2024-05-10
Substance
DAPSONE
Active strength
75 mg/g
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
DAPSONE75 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8W5C518302
Rxcui1741905

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
72578-094-01Dapsone30 g in 1 BOTTLE, PUMPGEL302
72578-094-01Dapsone1 in 1 CARTONGEL12
72578-094-02Dapsone60 g in 1 BOTTLE, PUMPGEL602
72578-094-02Dapsone1 in 1 CARTONGEL12
72578-094-03Dapsone90 g in 1 BOTTLE, PUMPGEL902
72578-094-03Dapsone1 in 1 CARTONGEL12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72578-094-02GM - Gram72578-094c2fe367c-5ba4-43a0-a43b-acccf7a6c5a512024-06-10
72578-094-03GM - Gram72578-094d676df7b-6b1b-4364-ab5c-4246f1d36c7612024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72578-094DAPSONE GEL [VIONA PHARMACEUTICALS INC]2Current NDC, 6 package rows20240512_30867c69-cf3c-4360-8e56-db96e0b0c3ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1741905dapsone 7.5 % Topical GelPSN30867c69-cf3c-4360-8e56-db96e0b0c3ab2
1741905dapsone 0.075 MG/MG Topical GelSCD30867c69-cf3c-4360-8e56-db96e0b0c3ab2
1741905dapsone 7.5 % Topical GelSY30867c69-cf3c-4360-8e56-db96e0b0c3ab2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72578-094-01725780094011 BOTTLE, PUMP in 1 CARTON (72578-094-01) / 30 g in 1 BOTTLE, PUMP2024-05-10NoNoHistorical
72578-094-02725780094021 BOTTLE, PUMP in 1 CARTON (72578-094-02) / 60 g in 1 BOTTLE, PUMP2024-05-10NoNoHistorical
72578-094-03725780094031 BOTTLE, PUMP in 1 CARTON (72578-094-03) / 90 g in 1 BOTTLE, PUMP2024-05-10NoNoHistorical