NDC 72934-1064

DAPSONE 8.5% / NIACINAMIDE 2% / SPIRONOLACTONE 5%

Dapsone 8.5% / Niacinamide 2% / Spironolactone 5%

DAPSONE 8.5% / NIACINAMIDE 2% / SPIRONOLACTONE 5% is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Sincerus Florida, Llc. The primary component is Spironolactone; Dapsone; Niacinamide.

Product ID72934-1064_887a6d0f-d339-48b9-e053-2a95a90af2a0
NDC72934-1064
Product TypeHuman Prescription Drug
Proprietary NameDAPSONE 8.5% / NIACINAMIDE 2% / SPIRONOLACTONE 5%
Generic NameDapsone 8.5% / Niacinamide 2% / Spironolactone 5%
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2019-05-10
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameSincerus Florida, LLC
Substance NameSPIRONOLACTONE; DAPSONE; NIACINAMIDE
Active Ingredient Strength5 g/100g; g/100g; g/100g
Pharm ClassesAldosterone Antagonist [EPC],Aldosterone Antagonists [MoA],Sulfone [EPC],Sulfones [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 72934-1064-2

30 g in 1 BOTTLE, PUMP (72934-1064-2)
Marketing Start Date2019-05-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72934-1064-2 [72934106402]

DAPSONE 8.5% / NIACINAMIDE 2% / SPIRONOLACTONE 5% GEL
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2019-05-10

Drug Details

Active Ingredients

IngredientStrength
SPIRONOLACTONE5 g/100g

Pharmacological Class

  • Aldosterone Antagonist [EPC]
  • Aldosterone Antagonists [MoA]
  • Sulfone [EPC]
  • Sulfones [CS]
  • Aldosterone Antagonist [EPC]
  • Aldosterone Antagonists [MoA]
  • Sulfone [EPC]
  • Sulfones [CS]

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