Dapsone

Product NDC
62332-663
11-digit product format
623320663
Labeler code
62332
Product ID
62332-663_5fa76202-2367-486b-bfe8-73f3dcd5a574
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dapsone
Dosage form
GEL
Route
TOPICAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA215718
Marketing category
ANDA
Marketing start
2023-10-30
Substance
DAPSONE
Active strength
75 mg/g
Pharmacologic classes
Sulfone [EPC], Sulfones [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dapsone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DAPSONE75 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8W5C518302
Rxcui1741905

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
62332-663-30Dapsone1 in 1 CARTONGEL16
62332-663-30Dapsone30 g in 1 BOTTLE, PUMPGEL306
62332-663-60Dapsone60 g in 1 BOTTLE, PUMPGEL606
62332-663-60Dapsone1 in 1 CARTONGEL16
62332-663-90Dapsone90 g in 1 BOTTLE, PUMPGEL906
62332-663-90Dapsone1 in 1 CARTONGEL16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-663DAPSONE GEL [ALEMBIC PHARMACEUTICALS INC.]6Current NDC, 6 package rows20250406_2811f7de-13bf-45cd-8413-5b04d11f40ff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1741905dapsone 7.5 % Topical GelPSN2811f7de-13bf-45cd-8413-5b04d11f40ff6
1741905dapsone 0.075 MG/MG Topical GelSCD2811f7de-13bf-45cd-8413-5b04d11f40ff6
1741905dapsone 7.5 % Topical GelSY2811f7de-13bf-45cd-8413-5b04d11f40ff6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62332-663-30623320663301 BOTTLE, PUMP in 1 CARTON (62332-663-30) / 30 g in 1 BOTTLE, PUMP2023-10-30NoNoCurrent
62332-663-60623320663601 BOTTLE, PUMP in 1 CARTON (62332-663-60) / 60 g in 1 BOTTLE, PUMP2023-10-30NoNoCurrent
62332-663-90623320663901 BOTTLE, PUMP in 1 CARTON (62332-663-90) / 90 g in 1 BOTTLE, PUMP2023-10-30NoNoCurrent