DAPSONE

Product NDC
60758-670
11-digit product format
607580670
Labeler code
60758
Product ID
60758-670_41079403-219e-4194-90e8-3b9b83dcf298
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dapsone
Dosage form
GEL
Route
TOPICAL
Labeler
Pacific Pharma, Inc.
Application
NDA021794
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2017-10-18
Substance
DAPSONE
Active strength
50 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
DAPSONE50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8W5C518302
Rxcui607295

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
60758-670-30DAPSONE30 g in 1 TUBEGEL306
60758-670-30DAPSONE1 in 1 CARTONGEL16
60758-670-60DAPSONE60 g in 1 TUBEGEL606
60758-670-60DAPSONE1 in 1 CARTONGEL16
60758-670-90DAPSONE1 in 1 CARTONGEL16
60758-670-90DAPSONE90 g in 1 TUBEGEL906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60758-670-60GM - Gram60758-670f0e06b3b-4b7e-4175-9d03-8f5ca10e723012017-11-06
60758-670-90GM - Gram60758-670ac19c257-5ec1-4fda-9967-2b779038c9a212017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60758-670DAPSONE GEL [PACIFIC PHARMA, INC.]5Current NDC, Legacy NDC, 6 package rows20230425_8dbe1a41-6d9d-414f-aa9c-09bd95857e2a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
607295dapsone 5 % Topical GelPSN8dbe1a41-6d9d-414f-aa9c-09bd95857e2a6
607295dapsone 0.05 MG/MG Topical GelSCD8dbe1a41-6d9d-414f-aa9c-09bd95857e2a6
607295dapsone 5 % Topical GelSY8dbe1a41-6d9d-414f-aa9c-09bd95857e2a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60758-670-30607580670301 TUBE in 1 CARTON (60758-670-30) / 30 g in 1 TUBE1 tube2017-10-180000-00-00NoNoCurrent
60758-670-60607580670601 TUBE in 1 CARTON (60758-670-60) / 60 g in 1 TUBE1 tube2017-10-180000-00-00NoNoCurrent
60758-670-90607580670901 TUBE in 1 CARTON (60758-670-90) / 90 g in 1 TUBE1 tube2017-10-180000-00-00NoNoCurrent