DAPSONE

Product NDC
10135-654
11-digit product format
101350654
Labeler code
10135
Product ID
10135-654_afbef0ba-7481-405d-9219-62ec25d9a618
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dapsone
Dosage form
TABLET
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA206505
Marketing category
ANDA
Marketing start
2018-05-01
Marketing end
0000-00-00
Substance
DAPSONE
Active strength
25 mg/1
Pharmacologic classes
Sulfone [EPC],Sulfones [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10135-654-012020-01-31C16284748780-19d75b9d1-01b0-f424-e053-dadaa90a57ceDapsone
10135-654-302020-01-31C16284748780-19d75b9d1-01b0-f424-e053-dadaa90a57ceDapsone

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-654-01DAPSONE100 in 1 BOTTLETABLET1001
10135-654-30DAPSONE30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-654-01EA - Each10135-6542d9d5e4f-75a9-4cc6-b7d6-15d7473630a912018-07-03
10135-654-30EA - Each10135-6540c7fd518-3ddf-4488-8373-dc48019fb4d512018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-654DAPSONE TABLET [MARLEX PHARMACEUTICALS INC]1Legacy NDC, 2 package rows20180501_6c2159ce-5ef2-418c-bb14-e58f55438f80.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197557dapsone 100 MG Oral TabletPSN6c2159ce-5ef2-418c-bb14-e58f55438f801
197558dapsone 25 MG Oral TabletPSN6c2159ce-5ef2-418c-bb14-e58f55438f801
197557dapsone 100 MG Oral TabletSCD6c2159ce-5ef2-418c-bb14-e58f55438f801
197558dapsone 25 MG Oral TabletSCD6c2159ce-5ef2-418c-bb14-e58f55438f801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10135-654-0110135065401100 in 1 BOTTLEHistorical
10135-654-301013506543030 in 1 BOTTLEHistorical