FDA.reportPublic FDA data

Dapsone

Product NDC
13925-505
11-digit product format
139250505
Labeler code
13925
Product ID
13925-505_ec807b3c-14d5-47f0-a239-bff0363ec49b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dapsone
Dosage form
TABLET
Route
ORAL
Labeler
Seton Pharmaceuticals
Application
ANDA086842
Marketing category
ANDA
Marketing start
2016-03-10
Marketing end
2026-07-31
Substance
DAPSONE
Active strength
100 mg/1
Pharmacologic classes
Sulfone [EPC], Sulfones [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dapsone

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13925-505-012025-09-19C16284748780-19d75b9d0-fb89-f424-e053-dadaa90a57ceDAPSONE Tablets, USP 25 mg & 100 mg
13925-505-302025-09-19C16284748780-19d75b9d0-fb89-f424-e053-dadaa90a57ceDAPSONE Tablets, USP 25 mg & 100 mg
13925-505-012022-01-28C16284748780-19d75b9d0-fb89-f424-e053-dadaa90a57ceDAPSONE Tablets, USP 25 mg & 100 mg
13925-505-302022-01-28C16284748780-19d75b9d0-fb89-f424-e053-dadaa90a57ceDAPSONE Tablets, USP 25 mg & 100 mg
13925-505-012020-04-30C16284748780-19d75b9d0-fb89-f424-e053-dadaa90a57ceDAPSONE Tablets, USP 25 mg & 100 mg
13925-505-302020-04-30C16284748780-19d75b9d0-fb89-f424-e053-dadaa90a57ceDAPSONE Tablets, USP 25 mg & 100 mg
13925-505-012020-01-31C16284748780-19d75b9d0-fb89-f424-e053-dadaa90a57ceDAPSONE Tablets, USP 25 mg & 100 mg
13925-505-302020-01-31C16284748780-19d75b9d0-fb89-f424-e053-dadaa90a57ceDAPSONE Tablets, USP 25 mg & 100 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13925-505-01Dapsone100 in 1 BOTTLETABLET1004
13925-505-30Dapsone2 in 1 CARTONTABLET24
13925-505-30Dapsone15 in 1 BLISTER PACKTABLET154

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13925-505-01EA - Each13925-505893b4a0f-da31-40a9-aa2f-cd603f1aee2212016-04-04
13925-505-30EA - Each13925-50574641719-06cb-4789-83fa-46e4abf6f62e12016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13925-505DAPSONE TABLET [SETON PHARMACEUTICALS]3Current NDC, Legacy NDC, 3 package rows20200501_229af266-d901-43e2-828a-4931d1124ea3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197557dapsone 100 MG Oral TabletPSN229af266-d901-43e2-828a-4931d1124ea34
197558dapsone 25 MG Oral TabletPSN229af266-d901-43e2-828a-4931d1124ea34
197557dapsone 100 MG Oral TabletSCD229af266-d901-43e2-828a-4931d1124ea34
197558dapsone 25 MG Oral TabletSCD229af266-d901-43e2-828a-4931d1124ea34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13925-505-0113925050501100 TABLET in 1 BOTTLE (13925-505-01) 100 tablet2016-03-102026-07-31NoNoCurrent
13925-505-30139250505302 BLISTER PACK in 1 CARTON (13925-505-30) > 15 TABLET in 1 BLISTER PACK2 blister pack2016-03-210000-00-00NoNoCurrent