Dapsone

Product NDC
70771-1538
11-digit product format
707711538
Labeler code
70771
Product ID
70771-1538_ae448df2-611f-4d56-911f-11d01983726f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dapsone
Dosage form
GEL
Route
TOPICAL
Labeler
Zydus Lifesciences Limited
Application
ANDA214019
Marketing category
ANDA
Marketing start
2024-05-10
Substance
DAPSONE
Active strength
75 mg/g
Pharmacologic classes
Sulfone [EPC], Sulfones [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
8W5C518302DAPSONE80-08-0DAPSONE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70771-1538-2707711538021 BOTTLE, PUMP in 1 CARTON (70771-1538-2) / 30 g in 1 BOTTLE, PUMP2024-05-10NoNoHistorical
70771-1538-3707711538031 BOTTLE, PUMP in 1 CARTON (70771-1538-3) / 60 g in 1 BOTTLE, PUMP2024-05-10NoNoHistorical
70771-1538-8707711538081 BOTTLE, PUMP in 1 CARTON (70771-1538-8) / 90 g in 1 BOTTLE, PUMP2024-05-10NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Dapsone GelZydus Lifesciences Limited2024-05-09HUMAN PRESCRIPTION DRUG LABEL1