Dapsone

Product NDC
51672-4198
11-digit product format
516724198
Labeler code
51672
Product ID
51672-4198_4d449249-4225-5741-e063-6394a90aa772
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dapsone
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA209430
Marketing category
ANDA
Marketing start
2019-03-01
Substance
DAPSONE
Active strength
100 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
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-4198-2Dapsone2 in 1 CARTONTABLET24
51672-4198-2Dapsone15 in 1 BLISTER PACKTABLET154
51672-4198-6Dapsone30 in 1 BOTTLETABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4198DAPSONE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]3Current NDC, Legacy NDC, 3 package rows20190312_cb312185-b9f1-4fa4-9481-bcf5d9bb3edf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197557dapsone 100 MG Oral TabletPSNcb312185-b9f1-4fa4-9481-bcf5d9bb3edf4
197558dapsone 25 MG Oral TabletPSNcb312185-b9f1-4fa4-9481-bcf5d9bb3edf4
197557dapsone 100 MG Oral TabletSCDcb312185-b9f1-4fa4-9481-bcf5d9bb3edf4
197558dapsone 25 MG Oral TabletSCDcb312185-b9f1-4fa4-9481-bcf5d9bb3edf4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-4198-2516724198022 BLISTER PACK in 1 CARTON (51672-4198-2) > 15 TABLET in 1 BLISTER PACK2 blister pack2019-03-010000-00-00NoNoCurrent
51672-4198-65167241980630 TABLET in 1 BOTTLE (51672-4198-6) 30 tablet2019-03-010000-00-00NoNoCurrent