Dapsone

Product NDC
51672-1387
11-digit product format
516721387
Labeler code
51672
Product ID
51672-1387_38e593e2-d4a5-b8dd-e063-6394a90a62c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dapsone
Dosage form
GEL
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
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
51672-1387-2Dapsone30 g in 1 TUBEGEL306
51672-1387-2Dapsone1 in 1 CARTONGEL16
51672-1387-3Dapsone60 g in 1 TUBEGEL606
51672-1387-3Dapsone1 in 1 CARTONGEL16
51672-1387-8Dapsone1 in 1 CARTONGEL16
51672-1387-8Dapsone90 g in 1 TUBEGEL906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1387-3GM - Gram51672-138733e53a7e-2c7f-4d50-8165-1c7544452e5812017-11-06
51672-1387-8GM - Gram51672-138715265e32-1da9-4b8d-9a07-871b94a9d4a312017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1387DAPSONE GEL [TARO PHARMACEUTICALS U.S.A., INC.]5Current NDC, Legacy NDC, 6 package rows20250122_97e6444c-1496-4508-9434-8a2a93225e17.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
607295dapsone 5 % Topical GelPSN97e6444c-1496-4508-9434-8a2a93225e176
607295dapsone 0.05 MG/MG Topical GelSCD97e6444c-1496-4508-9434-8a2a93225e176
607295dapsone 5 % Topical GelSY97e6444c-1496-4508-9434-8a2a93225e176

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1387-2516721387021 TUBE in 1 CARTON (51672-1387-2) / 30 g in 1 TUBE1 tube2017-10-160000-00-00NoNoCurrent
51672-1387-3516721387031 TUBE in 1 CARTON (51672-1387-3) / 60 g in 1 TUBE1 tube2017-10-160000-00-00NoNoCurrent
51672-1387-8516721387081 TUBE in 1 CARTON (51672-1387-8) / 90 g in 1 TUBE1 tube2017-10-160000-00-00NoNoCurrent