Dapsone 25mg

Product NDC
85185-104
11-digit product format
851850104
Labeler code
85185
Product ID
85185-104_50209cd1-afc6-53f4-e063-6394a90af9cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dapsone 25mg
Dosage form
TABLET
Route
ORAL
Labeler
Solis Pharmaceuticals Inc.
Application
ANDA203887
Marketing category
ANDA
Marketing start
2016-05-09
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 25mg
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
85185-104-01Dapsone 25mg30 in 1 BOTTLETABLET301
85185-104-02Dapsone 25mg100 in 1 BOTTLETABLET1001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197557dapsone 100 MG Oral TabletPSN50204029-4c29-5b8d-e063-6394a90af3831
197558dapsone 25 MG Oral TabletPSN50204029-4c29-5b8d-e063-6394a90af3831
197557dapsone 100 MG Oral TabletSCD50204029-4c29-5b8d-e063-6394a90af3831
197558dapsone 25 MG Oral TabletSCD50204029-4c29-5b8d-e063-6394a90af3831

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85185-104-018518501040130 TABLET in 1 BOTTLE (85185-104-01) 30 tablet2016-05-09NoNoCurrent
85185-104-0285185010402100 TABLET in 1 BOTTLE (85185-104-02) 100 tablet2016-05-09NoNoCurrent