DAPSONE

Product NDC
59651-666
11-digit product format
596510666
Labeler code
59651
Product ID
59651-666_83966a34-02d4-4794-bc2b-3e612b121973
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DAPSONE
Dosage form
GEL
Route
TOPICAL
Labeler
Aurobindo Pharma Limited
Application
ANDA218457
Marketing category
ANDA
Marketing start
2025-04-04
Substance
DAPSONE
Active strength
50 mg/g
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
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
59651-666-60DAPSONE60 g in 1 TUBEGEL602
59651-666-60DAPSONE1 in 1 CARTONGEL12
59651-666-90DAPSONE1 in 1 CARTONGEL12
59651-666-90DAPSONE90 g in 1 TUBEGEL902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-666-60GM - Gram59651-666cd1f1ca3-9750-4e5f-9a65-2f36492bde9b12026-02-05
59651-666-90GM - Gram59651-666deda3d29-b6e2-44a5-9540-0332c1823dc312026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-666DAPSONE GEL [AUROBINDO PHARMA LIMITED]1Current NDC, 4 package rows20250418_acd33f0b-8563-467a-93db-a11902331528.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
607295dapsone 5 % Topical GelPSNacd33f0b-8563-467a-93db-a119023315282
607295dapsone 0.05 MG/MG Topical GelSCDacd33f0b-8563-467a-93db-a119023315282
607295dapsone 5 % Topical GelSYacd33f0b-8563-467a-93db-a119023315282

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-666-60596510666601 TUBE in 1 CARTON (59651-666-60) / 60 g in 1 TUBE1 tube2025-04-04NoNoCurrent
59651-666-90596510666901 TUBE in 1 CARTON (59651-666-90) / 90 g in 1 TUBE1 tube2025-04-04NoNoCurrent