Dapsone

Product NDC
49938-101
11-digit product format
499380101
Labeler code
49938
Product ID
49938-101_aef3166f-2850-4709-a00f-4c8e784d8022
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dapsone
Dosage form
TABLET
Route
ORAL
Labeler
Jacobus Pharmaceutical Company, Inc.
Application
ANDA086842
Marketing category
ANDA
Marketing start
2008-08-15
Marketing end
2025-08-31
Substance
DAPSONE
Active strength
100 mg/1
Pharmacologic classes
Sulfone [EPC], Sulfones [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49938-101-01EA - Each49938-101517185e5-4993-405d-8a30-feec14f6d54712016-03-04
49938-101-30EA - Each49938-101fc6e15f1-31e3-4a53-9c99-5072e0e6834a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DAPSONEACTIVE INGREDIENT8W5C518302DAPSONE TABLET [JACOBUS PHARMACEUTICAL COMPANY, INC.]4
DAPSONEACTIVE MOIETY8W5C518302DAPSONE TABLET [JACOBUS PHARMACEUTICAL COMPANY, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDAPSONE TABLET [JACOBUS PHARMACEUTICAL COMPANY, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DAPSONE TABLET [JACOBUS PHARMACEUTICAL COMPANY, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DAPSONE TABLET [JACOBUS PHARMACEUTICAL COMPANY, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDAPSONE TABLET [JACOBUS PHARMACEUTICAL COMPANY, INC.]4
DAPSONEACTIVE INGREDIENT8W5C518302DAPSONE TABLET [PHYSICIANS TOTAL CARE, INC.]2
DAPSONEACTIVE MOIETY8W5C518302DAPSONE TABLET [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDAPSONE TABLET [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DAPSONE TABLET [PHYSICIANS TOTAL CARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DAPSONE TABLET [PHYSICIANS TOTAL CARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDAPSONE TABLET [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49938-101DAPSONE TABLET [JACOBUS PHARMACEUTICAL COMPANY, INC.]6Legacy NDC20221220_0792169d-c6f9-4af0-93ae-b75d710c47a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197557dapsone 100 MG Oral TabletPSN2b87248b-66df-70ac-e054-00144ff8d46c2
197557dapsone 100 MG Oral TabletPSNd97e6985-b508-43c0-8c1f-6dfe9cc8a5282
197558dapsone 25 MG Oral TabletPSN2b87248b-66df-70ac-e054-00144ff8d46c2
197558dapsone 25 MG Oral TabletPSNd97e6985-b508-43c0-8c1f-6dfe9cc8a5282
197557dapsone 100 MG Oral TabletSCD2b87248b-66df-70ac-e054-00144ff8d46c2
197557dapsone 100 MG Oral TabletSCDd97e6985-b508-43c0-8c1f-6dfe9cc8a5282
197558dapsone 25 MG Oral TabletSCD2b87248b-66df-70ac-e054-00144ff8d46c2
197558dapsone 25 MG Oral TabletSCDd97e6985-b508-43c0-8c1f-6dfe9cc8a5282

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49938-101-0149938010101100 TABLET in 1 BOTTLE (49938-101-01) 100 tablet2016-02-082023-11-30NoNoCurrent
49938-101-28499380101282 BLISTER PACK in 1 CARTON (49938-101-28) > 14 TABLET in 1 BLISTER PACK2 blister pack2008-08-150000-00-00NoNoCurrent
49938-101-30499380101302 BLISTER PACK in 1 CARTON (49938-101-30) > 15 TABLET in 1 BLISTER PACK2 blister pack2008-08-150000-00-00NoNoCurrent