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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
8W5C518302DAPSONE80-08-0DAPSONE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-666-60596510666601 TUBE in 1 CARTON (59651-666-60) / 60 g in 1 TUBE1 tube2025-04-04NoNoHistorical
59651-666-90596510666901 TUBE in 1 CARTON (59651-666-90) / 90 g in 1 TUBE1 tube2025-04-04NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
DAPSONEAurobindo Pharma Limited | APL HEALTHCARE LIMITED2025-05-30Human Prescription Drug Label2