Dapsone

Product NDC
16714-956
11-digit product format
167140956
Labeler code
16714
Product ID
16714-956_3980a223-560e-186f-e063-6394a90a0d68
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dapsone
Dosage form
GEL
Route
TOPICAL
Labeler
NORTHSTAR RX LLC
Application
ANDA209506
Marketing category
ANDA
Marketing start
2017-10-16
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
16714-956-01Dapsone60 g in 1 TUBEGEL602
16714-956-01Dapsone1 in 1 CARTONGEL12
16714-956-02Dapsone90 g in 1 TUBEGEL902
16714-956-02Dapsone1 in 1 CARTONGEL12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-956-01GM - Gram16714-956447396cd-9293-4214-9b15-18284347fe4e12019-08-06
16714-956-02GM - Gram16714-95617083b6f-f703-4093-b3df-df50d8fca51d12019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-956DAPSONE GEL [NORTHSTAR RX LLC]1Current NDC, Legacy NDC, 4 package rows20190516_91d027f1-cbc6-4066-870b-01b1ddb1f48f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
607295dapsone 5 % Topical GelPSN91d027f1-cbc6-4066-870b-01b1ddb1f48f2
607295dapsone 0.05 MG/MG Topical GelSCD91d027f1-cbc6-4066-870b-01b1ddb1f48f2
607295dapsone 5 % Topical GelSY91d027f1-cbc6-4066-870b-01b1ddb1f48f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-956-01167140956011 TUBE in 1 CARTON (16714-956-01) / 60 g in 1 TUBE1 tube2019-04-250000-00-00NoNoCurrent
16714-956-02167140956021 TUBE in 1 CARTON (16714-956-02) / 90 g in 1 TUBE1 tube2019-04-250000-00-00NoNoCurrent