NDC 51672-1388

Dapsone

Dapsone

Dapsone is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Taro Pharmaceuticals U.s.a., Inc.. The primary component is Dapsone.

Product ID51672-1388_10cc0056-7724-4aa0-8de9-38455805f695
NDC51672-1388
Product TypeHuman Prescription Drug
Proprietary NameDapsone
Generic NameDapsone
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2019-06-26
Marketing CategoryANDA / ANDA
Application NumberANDA210191
Labeler NameTaro Pharmaceuticals U.S.A., Inc.
Substance NameDAPSONE
Active Ingredient Strength75 mg/g
Pharm ClassesSulfone [EPC],Sulfones [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 51672-1388-2

1 BOTTLE, PUMP in 1 CARTON (51672-1388-2) > 30 g in 1 BOTTLE, PUMP
Marketing Start Date2019-06-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51672-1388-2 [51672138802]

Dapsone GEL
Marketing CategoryANDA
Application NumberANDA210191
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-06-26

NDC 51672-1388-8 [51672138808]

Dapsone GEL
Marketing CategoryANDA
Application NumberANDA210191
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2019-06-26

NDC 51672-1388-3 [51672138803]

Dapsone GEL
Marketing CategoryANDA
Application NumberANDA210191
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2019-06-26

Drug Details

Active Ingredients

IngredientStrength
DAPSONE75 mg/g

OpenFDA Data

SPL SET ID:32fcb7e0-5a6d-4d95-b81c-148012a54112
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1741905
  • Pharmacological Class

    • Sulfone [EPC]
    • Sulfones [CS]

    NDC Crossover Matching brand name "Dapsone" or generic name "Dapsone"

    NDCBrand NameGeneric Name
    0378-4830DapsoneDapsone
    0904-7018DAPSONEDapsone
    0904-7019DAPSONEDapsone
    10135-654DAPSONEDapsone
    10135-655DAPSONEDapsone
    13668-605dapsonedapsone
    13925-504DapsoneDapsone
    13925-505DapsoneDapsone
    16714-956DapsoneDapsone
    29033-036DapsoneDapsone
    29033-037DapsoneDapsone
    42291-298DapsoneDapsone
    42291-299DapsoneDapsone
    43353-222DapsoneDapsone
    43353-223DapsoneDapsone
    47781-333Dapsonedapsone
    47781-334Dapsonedapsone
    49938-101DapsoneDapsone
    49938-102DapsoneDapsone
    51672-1387DapsoneDapsone
    51672-1388DapsoneDapsone
    51672-4197DapsoneDapsone
    68151-2693DapsoneDapsone
    69543-150DapsoneDapsone
    69543-151DapsoneDapsone
    70954-136DAPSONEDAPSONE
    70954-135DAPSONEDAPSONE
    51672-4198DapsoneDapsone
    55695-005DapsoneDapsone
    55695-025DapsoneDapsone
    60429-496DapsoneDapsone
    60429-495DapsoneDapsone
    60758-670DAPSONEDAPSONE
    51672-5307DapsoneDapsone
    0023-3670ACZONEdapsone
    0023-5206ACZONEdapsone
    16110-367ACZONEdapsone
    16110-526Aczonedapsone

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